track trace with sap solutions sh

1

Printed and bounded in Germany 2012

ISBN 978-3-00-039041-8

Author

Stefan Hockenberger

Track & Trace with SAP Solutions

2

Table of figures 7

Track & Trace wiTh saP soluTions 10

high level inTroducTion To Track & Trace 12

1 Introduction 13

2 Which industries are affected and why 21

saP’s vision of Track & Trace 22

1 Trends – Why traceability? 23

2 Different ways of Traceability 25

2.1 Traceability Types – Traceability domain 25

2.2 Unified Traceability 26

2.3 Internal Traceability 28

2.4 External Traceability 28

2.5 Deployment of internal and external Traceability 30

3 SAP’s Track & Trace Solution Portfolio today 31

3.1 SAP Global Batch Traceability 35

3.2 SAP Event Management 38

3.3 SAP Object Event Repository 39

4 Scenarios as to how the Track & Trace domain may develop 41

4.1 New technologies 42

4.2 Value Chain traceability 43

gs1 sTandards for Track & Trace 44

1 Welcome to the world of GS1 Standards - Managing complexity

and ensuring compliance 45

2 How the Standards work 46

3 Traceability Models 47

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Table of Content

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4 GS1 EPCIS 50

4.1 Introduction to GS1 EPCIS 50

4.2 EPCIS - Bridging the physical flow and the information flow 52

5 GS1 Standards in the pharmaceutical industry 54

5.1 GS1 Healthcare - Leveraging global standards to enable

pharma traceability 54

5.2 Traceability in Healthcare - Regulatory developments 55

6 Advancing a unified approach 57

drivers of Track & Trace 58

1 Legislations 59

1.1 Pharmaceutical Industry 60

1.2 Tobacco Industry 68

1.3 Explosives 71

2 Beyond compliance: potential benefits of Track & Trace 74

2.1 Improved operations 75

2.1.1 Process standardization and harmonization 75

2.1.2 Gain production performance KPIs 76

2.1.3 Gain warehouse performance KPIs 76

2.2 Competitive advantage 77

2.2.1 Customer consumption, alerts, monitoring 78

2.2.2 E-Leaflets and targeted illness or product info 78

2.2.3 Increased customer loyalty 78

2.2.4 Establishing a direct dialog with consumers 79

2.3 Better Waste Management 80

2.3.1 Waste statistics (Intelligence) 80

2.3.2 Avoid waste to revert to Supply Chain 81

2.4 Visibility in parallel trading 81

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2.5 Avoid brand damage 82

2.5.1 Avoid consumption of recalled batches 82

2.5.2 Avoid anti-counterfeits 83

2.5.3 Avoid consumption of expired product 83

2.6 Improved recall Management 83

2.6.1 Faster and partial batch recalls 84

2.6.2 Faster version replacement 84

2.6.3 Theft stocks recalls 84

2.7 Shipment visibility and alerting 85

2.7.1 3 PL performance measurements 85

2.7.2 Error-free pick & pack 85

2.8 Optimized Inventory 86

2.9 Additional aspects to consider 87

sofTware comPonenTs for Track & Trace and Their feaTures 88

1 Requirements for Track & Trace Software Components 89

1.1 Introduction 89

1.2 Process example to explain the software requirements 92

1.3 Summary of the necessary components and requirements 97

1.4 Short Description of necessary de facto standard components 100

2 Architecture examples of implemented Track & Trace

software landscapes 103

3 Detailed description of the software components 107

3.1 Printing Technologies for T&T related marking activities 107

3.1.1 Introduction 107

3.1.2 Available printing Technologies 108

3.1.3 Conclusion 112

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Table of Content

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3.2 Processes, Considerations and Software at production/packaging lines 113

3.2.1 Quick Overview of the Systech Software Components 113

3.2.2 Serialization walkthrough – old view, new view 115

3.2.3 Serialization Requirements/Considerations 117

3.2.4 How it works/How it should work 117

3.2.5 Protect data/packaging integrity and ensuring data accuracy 119

3.2.6 Protect packaging line efficiency and throughput 120

3.2.7 Serialization Considerations 121

3.2.8 Benefits of Systech’ Serialized Product Tracking (SPT) 122

3.2.9 The Bottom Line 129

3.3 SAP AII - Consolidation software/Edge Server 132

3.3.1 Functions and Features of SAP AII 132

3.4 SAP OER - Global Track & Trace Repository (EPCIS) 142

3.4.1 Classification of SAP OER in a global Track & Trace environment 142

3.4.2 Functions and Features of SAP OER 144

3.5 SAP Process Integration (SAP PI) 168

3.6 Mobile Scanning Solution 168

3.6.1 Movilizer for Track & Trace – Architecture 169

3.6.2 Technical Features of Movilizer for Track & Trace 170

3.6.3 Supported Processes 171

3.6.4 Security of Movilizer 180

3.6.5 Sample Screenshots of the mobile Application 184

besT PracTices - how To sTarT a global Track & Trace ProjecT 186

1 Disconnection of serialization and Track & Trace 187

2 Business Blueprint of a global Track & Trace System 188

2.1 Business Blueprint & Functional Specifications & Technical Mapping 189

2.1.1 Business Blueprint & Functional Specifications 190

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6 Table of Content

2.1.2 Technical mapping of the requirements 191

3 Movilitas Add-On’s for SAP Track & Trace 192

3.1 Randomization Add-On 193

3.2 Data Reconciliation cockpit Add-On 195

3.3 Authorities Reporting Add-On 197

3.4 The special events Add-On 200

3.5 The Performance Test Add-On 202

3.6 The Archiving Add-On 204

3.7 ECPIS Repository migration Add-On 205

3.8 The Industrial mobile scanning Add-On 206

3.9 The mobile app for event capturing, ID verification

and more 208

3.10 The logistics label printing Add-On 209

3.11 The lean Track & Trace Add-On 211

3.12 The 2cd level support package Add-On 213

auThors 214

definiTions, acronyms and abbreviaTions 218

aPPendix 225

1 Track & Trace Survey - Overview 225

2 Overview Survey Questions 226

3 Track & Trace Survey – Static Result 229

4 Track & Trace Survey - Dynamic Result 246

Page

7 Table of Figures

Page

fig. 1 High Level Process Flow Track & Trace 19

fig. 2 Pressures driving investments in traceability 24

fig. 3 Concept of unified traceability – levels of interrelated

traceability trajectories with an example service layer 27

fig. 4 Differentiates internal traceability from two external

traceability scenarios 29

fig. 5 Mapping of internal and external traceability example

domains to ‘On Premise’ and ‘On Demand’ solutions 30

fig. 6 Solution Domains addressed by SAP’s Track & Trace

Solution Portfolio 31

fig. 7 SAP Track & Trace Solutions at a quick glance 34

fig. 8 SAP Global Batch Traceability (SAP GBT) 35

fig. 9 SAP GBT – Search Batches 36

fig. 10 SAP GBT - Traceability Network Graphic 37

fig. 11 One-up, One-down Model 48

fig. 12 Pharma Serialization Deadlines 60

fig. 13 Big Picture: Potential benefits of Track & Trace 73

fig. 14 Overview Track & Trace process steps 91

fig. 15 High Level Software Architecture SAP AIE 101

fig. 16 Architecture example 1 – SAP’s standard proposition 104

fig. 17 Architecture example 2 – No Edge Server (SAP AII) 105

fig. 18 Architecture example 3 – Global Edge Server (SAP AII) 106

fig. 19 Traditional Packaging Paradigm 115

fig. 20 Serialization Packaging Paradigm 116

fig. 21 Timeline of changes in regards to EPC Global and GS1 standards 126

8 Table of Figures

Page

fig. 22 Configuration flexibility of packaging hierarchies and number

association 127

fig. 23 Scalability of Sentri, Advisor and Guardian (pharmaceutical view) 128

fig. 24 Bi-directional Data Flow 130

fig. 25 High Level Overview SAP AII 135

fig. 26 Rules & Activities Framework in SAP AII 136

fig. 27 Screenshot: Application Log 140

fig. 28 Main Features of SAP OER 143

fig. 29 Transaction SPROXY 145

fig. 30 View of the Integration Engine (Part of SAP PI stack

integrated in SAP OER) 147

fig. 31 SPRO transaction to configure fields for display and selection. 149

fig. 32 Sample of standard web report (Web Transaction) 149

fig. 33 Event Handler 151

fig. 34 Standard Event Handler in SAP OER - Header data 152

fig. 35 One Event Handler can handle multiple events 153

fig. 36 One Event Handler handling multiple hierarchies at different

points in time 154

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fig. 37 Graphical tool (“wizard”) for rule definition in the SAP OER

configuration workbench (Transaction SPRO) 156

fig. 38 Multichannel alerting 159

fig. 39 Central Number Range Management 161

fig. 40 Effort for dicing-type methods in relation to number

range exploitation 162

fig. 41 Movilizer for Track & Trace - Architecture 169

fig. 42 Overview supported Processes 171

fig. 43 Sample Hierarchy in SAP OER 172

fig. 44 Sample screenshots of a Marketing/Change Management

and communications app 176

fig. 45 Sample screenshots of a Marketing/Change Management

and communications app 178

fig. 46 Source system customer - Movilizer Cloud 182

fig. 47 Movilizer client - Movilizer Cloud 183

fig. 48 Sample Screenshots of the mobile application for Track & Trace 185

fig. 49 Serial Number Lifecycle 188

10 Track & Trace with SAP Solutions

Track & Trace with SAP Solutions

functions & features, standards, best

Practices, Benefi ts and other hints and

tips for starting a Track & Trace project.

functions & features, standards, best

and other hints and

starting a Track & Trace project.

11

The work inclusive all its contents are protected by copyright. All rights reserved. Reprint or reproduction (also in excerpts) in any form (prin-ting, photocopy or any other process) as well as saving, processing, duplication and distribution by electronic systems of any kind, as a whole or in excerpts, without the explicit written permission of the publisher is prohibited.Using this book and the realization of its containing information is explicitly at one´s own risk. Legal rights or compensation are ex-cluded. The work inclusive all its contents were worked out with greatest care. However, typographical errors or wrong information are possible. Neither the publisher nor the author may incur liability for immediacy, correctness or completeness of the contained information or possible typographical errors in the book. Neither the author nor the publisher may be held responsible or may incur liability for any wrong information and effects resulting out of it. The operators of the respective web pages are responsible for the content of printed web pages in this book.

Special Acknowledgements

Special thanks to jasmin sipahi and jonathan wildermuth

for building most of the graphics and making this look like a real book!

Special thanks to Pedram mohebbi

for spending hours on making this readable for English natives!

Special thanks to elina muratow

for proofreading!

Special thanks to all co-authors

for providing the valuable input!

Special thanks to all i those i may have forgotten!

12

i

High Level Introduction to Track & Trace

High Level Introduction to Track & Trace

13

1 Introduction

» why is Track & Trace becoming increasingly important for businesses?

Product piracy is an increasing problem for businesses in the broadest range of industries. A growing number

of companies are forced to confront piracy with measures such as serialization and Tracking & Tracing. Results

from surveys show that nearly every second consumer considers counterfeiting as a serious problem, and

nearly the same amount reported falling victim to counterfeiting.

However, Track & Trace offers businesses far more than assurances against counterfeiting and piracy. The

decision to serialize and track products on item level opens up a whole new range of options and can provide

real value added for the business. For example, the transparency that is gained as a result can facilitate better

control of recalls, loss reduction and the optimization of supply chain, marketing and sales strategies.

» what does Track & Trace mean?

‘Tracking’ means monitoring forward movement of finished goods through the supply chain and ensuring that

all taxes and duties have been paid and volumes verified.

‘Tracing’ means working backwards through the supply chain to establish where any genuine product was

diverted out of the legitimate supply chain.

Therefore Tracking & Tracing has the capability to determine the specific source of a particular product at the

lowest practical level of packaging, and to provide visibility to specific information (e.g. batch, lot, date, origin,

ingredients, safety, or recall status).

14 High Level Introduction to Track & Trace

» why is this useful?

The information can quickly tell the person querying the package or product on: what it is, where it came from,

whether it is subject to a recall or other security issue, when and where it was packed or manufactured and

in some cases, where the product was supposed to be shipped to (and therefore, whether it‘s in the correct

location).1

» from serialization over aggregation to Track & Trace

To achieve full Track & Trace the typical approach is to start with serialization. Serialization means to make

each single product unique by placing an item identifier on every single product. Typically the item identifier

is a Datamatrix-Code containing at least the product related GTIN paired with a serial number. This way the

product becomes the vehicle for carrying the information needed for Track and Trace and can be identified

individually. It is also then possible to store further product related information in a database linked to this

unique ID. Serialization takes place directly at the production lines and requires in most cases new printing and

scanning technologies and software.

The next big step after serialization is achieved is typically the aggregation. Aggregation is the process of

building packaging hierarchies and storing this relationship in a database. If, for example single products get

packed in a carton and these cartons get packed on a pallet, this relationship has to be recognized and stored

in a database using scanning processes. Each new packing level, e.g. cartons or pallets, also requires a unique

(serialized) identifier. Aggregation is a major step towards Track & Trace and the big advantage is that; once

the packaging hierarchy is built and stored in a database, only the highest-level identifier (e.g. pallet) has to be

15

1 Traceability: Giving every

product an authentic

identity, Package

Printing, June 1, 2008

scanned (identified) and all associated packed items in the hierarchy will automatically be known. This makes

it much easier to follow the items through the supply chain, as not every single item needs to be scanned at

different intervals in the supply chain. Aggregation can take place directly at production/packaging lines or, for

example, in distribution centers during re-packing. In most instances new or additional scanning technology

and software is required to capture the building of hierarchies and the movement of product through the

supply chain.

Once serialization and aggregation are achieved, everything is in place in order to completely Track & Trace

products through the supply chain. The final step is to define points in the supply chain where the products

or, the highest packaging level (due to aggregation) has to be scanned. As a result, the state (e.g. produced,

shipped, packed, dispensed, etc.) of all packed items can be changed in the database where the Track & Trace

data is stored (e.g. EPCIS). While serialization and aggregation take place in production and packaging lines or

in distribution centers, Tracking & Tracing mostly takes place in the supply chain.

The combination of having a unique identifier and capturing the information relating to the movement of the-

se aggregated products (when, where, what and why) is the best way to achieve a safe, secure and transparent

supply chain.

In this document, ‘Track & Trace’ will be addressed and no distinction will be made between ‘Track & Trace’

and serialization/aggregation. This is due to the fact that serialization and aggregation are integral parts of an

effective Track & Trace.


» how do things stand?

Under existing legislation, many pharmaceutical companies are obliged to serialize their products on item

level for certain markets and to pass on the complete tracking data e.g. to authorities. Consequently, the phar-

maceutical sector can be credited with a clear, leading role in the development of Track & Trace.

Nonetheless, even without statutory provisions, more and more companies are recognizing the value addition

that can be found in Tracking & Tracing. As such, the perceived high level of investment initially implied by the

introduction of complete tracking is rewarded with huge potential for improvements.

Tobacco companies, manufacturers of explosive products, luxury and high-tech products in particular as well

as manufacturers of licensed software are increasingly opting for Tracking & Tracing. It must be assumed that

other industries will recognize the value added in Tracking & Tracing in the near future or authorities will derive

benefits for consumers and therefore impose legislations. The consumer goods industry in particular should

expect to be subjected to legislation. Current media reports of contaminated foodstuffs re-emphasize the

significance of the topic and the need for action.

Ultimately, all businesses have one thing in common: they may all soon have to deal with Tracking & Tracing

and adapt their IT systems, production and packaging lines and business processes accordingly.

17

» how does Track & Trace work?

Track & Trace differs from other brand protection technologies in important ways. Overt and covert techno-

logies such as holograms, intaglio print, micro text, invisible images, and digital watermarks offer excellent

solutions for authentication, but cannot distinguish individual items at a unit level and cannot carry or point

to item-level data, something that is required for tracking & tracing.2

The key to implement Track & Trace is the ability to put variable data on item, case and/or pallet level (de-

pending on the granularity to which items need to be tracked) and to trace these items through the supply

chain. Radio-frequency identification and barcodes are two common technology methods used to deliver

traceability.

Typically a barcode or RFID transponder usually containing a combination of GTIN and serial number will be

applied to items on the production line. In some cases there will be an aggregation of the products, related to

the packaging hierarchy (e.g. item to case and case to pallet). Aggregation makes it easier to trace a bundle

of items through the supply chain as only the ID of the pallet has to be scanned and therefore identifying all

cases and items contained on the pallet.

Once the IDs are applied to the products; all product related events such as ‘produced’, ‘shipped’, ‘received’,

‘dispensed’ will be captured along the supply chain via scanning of these IDs with mobile devices. This captu-

red information will be stored in a database (EPCIS) together with product related information from produc-

tion such as ‘batch’, ‘manufacturing date’, ‘expiration date’ etc.

Authorities, consumers and/or supply chain partners can access this database to trace the origins of products

or to find the status of shipments. For example, this can be done by taking a picture of the 2D barcode using

a smartphone or entering the product ID in a dedicated website or search field of the database

and querying the related information out of the database.2 Traceability: Giving eve-

ry product an authentic

identity, Package Printing,

June 1, 2008


Fig. 1: High Level Process Flow Track & Trace

19

Fig. 1: High Level Process Flow Track & Trace


following these principles of Track & Trace it is possible to know e.g. at any point in the product’s life-

cycle, the following product related information:

» Who is the manufacturer of this product

» When and where was it produced

» When was the product shipped and received by certain parties

» Where is the product supposed to be at a certain time

» What is the expiration date of a product

» Is the Product ID known by the database

» How long was the product in the supply chain before reaching the point of consumption

» And much more depending of the granularity of stored information in the database

having this information in a database makes it easier for all parties such as manufacturers, authorities

and consumers to:

» Separate a counterfeited product from a genuine one

» Increase consumers safety

» Check whether all taxes and duties have been paid

» Discover grey-market products

» Optimize the supply chain and logistics

» Gaining information about consumers and their behaviors

» Offering customer loyalty programs and avoiding abuse of these

» And much more depending of the granularity of stored information in the database

21

2 Which industries are affected and why

As described previously, pharmaceutical companies are already obliged by legislations in various countries to

serialize at item level and to pass on the complete tracking data to authorities. This also applies to companies

in the tobacco and explosive goods industry.

Others adopt Track & Trace to address revenue lost due to counterfeiting and those whom recognize the sub-

stantial customer benefits of offering Track & Trace information.

However, in light of existing and forthcoming legislation requiring unique serialization and submission of elec-

tronic records to: authorities, supply chain partners and/or customers, more industries will need to adapt their

IT systems, production- and packaging lines and business processes in time for compliance.

from our experience this currently mainly affects the following industries:

» Shipping companies

» Returnable Transport Items

» Explosives

» Food & Beverage

» Toys

» Pharmaceutical, Medical devices, Hospital supplies, Blood supply

» Weapons

» Chemicals

» Software

» Tobacco

22 SAP’s vision of Track & Trace

ii

introduction from the world’s largest supplier of standard software

SAP’s vision of Track & Trace

saP ag (walldorf), known as the world’s largest supplier of standard software, identified

the need for Track & Trace software solutions at a very early stage and therefore started

to develop a software suite for this very problem over 10 years ago. The majority of well-

known companies that have addressed Track & Trace rely on these SAP products. No other

solution is currently able to manage the huge volume of data arising from serialization at

item level and complete tracking along the entire supply chain.

No other standard software solution offers such a broad range of functionalities and is

currently able to manage the huge volume of data arising from serialization at item level

and complete tracking along the entire supply chain.

23

1 Trends – Why traceability?

In today’s globalized economy, companies not only have global market opportunities but also face global

competition as well as global risks. Global risks can stem from counterfeited products that present a risk to

brands and Return on Investment regarding their Intellectual property (IP) and revenue as well as: from supply

risks or disruptions to raw materials sourced from global suppliers. In the global market place, quality issues

of single products can lead to enormous wide spread cost consequences and risks reverberating throughout

the whole value chain. In order to combat the spread of counterfeiting, some countries have enacted trace-

ability directives in certain value chains that posit a requirement on companies to report traceability data to

government databases.

Traceability can help in providing the visibility and intelligence of both global market opportunity as well as

risk, in an effective and speedy manner. Speed and availability of data is often a necessity to mitigate risk and

to identify and exploit new opportunities.

Companies with a superior command of their global market opportunity, resource network and attendant

goods and information flow have a clear competitive edge in the arena of global opportunity and competition.

Combined with global value and supply chain intelligence, traceability provides the core capability to both

effectively orchestrate goods to markets and to ensure efficient, synchronized and coordinated supplies.

Furthermore, there is the new phenomenon of the power of information at the fingertips of consumers enab-

led through smart computing devices. News of product quality issues spread fast through social network com-

munities such as ‘Twitter’. The immediate spread of this type of consumer communication and broadcasting

requires companies to act faster while facing product issues in order to avoid any damage to brand reputation,

liabilities and sales.


Fig. 2: Pressures driving investments in traceability

How about sustainability? If one stays true to the notion that you can only manage what you can measure,

then sustainability management requires high quality data. Why not use traceability as the backbone to re-

cord natural resource consumption data throughout a product’s lifecycle? This can be achieved if a product is

traced from the raw material stage till the point of consumption and its natural resource consumption data is

recorded as attributes throughout the product’s lifecycle.

Traceability systems today are in most cases expert systems serving a certain domain or line of business such

as supply chain management. These traceability systems serve scenarios for process compliance, logistical

supply chain Track & Trace, license key tracking, asset traceability, item serialized traceability for compliance,

batch traceability for Good manufacturing practice and recall. With few exceptions these systems are typically

deployed ‘On Premise’.

Further to the intrinsic value of the aforementioned, traceability systems can also be enablers. When tracea-

bility becomes a core part of the DNA of future corporate information system architecture within companies

(On Premise) and spanning entire value chains (On Demand) – traceability can enable complete product pro-

venance across a value chain from raw material to the point of consumption. With the right data model, expert

systems can leverage the traceability DNA for sustainability management, supply risk management, real-time

complex value and supply chain orchestration and provide real-time intelligence.

25

2 Different ways of Traceability

Track & Trace can be well defined as follows: “In distribution and logistics of many types of products, Track and

Trace or Tracking and Tracing, concerns a process of determining the current and past locations (and other

information) of a unique item or property.”

To attain authoritative traceability, which can ultimately add value in a variety of ways, it is useful to take a

deeper look at this definition of Traceability.

Firstly, one can distinguish internal from external traceability. Secondly, one can further differentiate different

traceability domains, look at different traceability object types and then look at methods of integration.

2.1 Traceability Types – Traceability domain

when looking at traceability one can distinguish different types of traceability

» Traceability of a product genealogy

» Batch- or serial number component level

» Product supply chain traceability

» Serialized

» Item serialized

» Batch level

» GTIN or part number level

» Product provenance and pedigree

» Logistical Track & Trace

» Parcel traceability

» Sea-freight container traceability

» Pallet level traceability

» Process traceability

» Procure-to-pay or order-to-cash

» Traceability for sustainability and product

footprint data recording


In many cases domain expert solutions are available for each type of traceability; in some cases expert solution

can also address a mixture of these types of traceability. For example with today’s SAP solutions; SAP Event

Management and SAP Object Event Repository. In Logistical Track & Trace the concept of handling units can

help to unify the access to different levels of distribution units.

2.2 Unified Traceability

However, ultimately; it may be necessary to arrive at data models that unify these various traceability domains

and combine various traceability trajectories such as genealogy to high resolution downstream supply chain

traceability – with sustainability data recording – in order to enable full product value chain traceability from

raw material to point of consumption together with their footprint on natural resource consumption.

27

Fig. 3: Concept of unified traceability – levels of interrelated traceability trajectories

with an example service layer


2.3 Internal Traceability

Internal traceability looks at traceability within the boundaries of a corporation. Here one can differentiate

whether the traceability serves a certain line of business domain, geography or spans traceability across cor-

porate geographies for a functional domain. An important aspect of any traceability solution (even within the

boundaries of a corporation) is a well-defined concept of data access security.

2.4 External Traceability

External traceability refers to traceability, which is extended beyond the boundaries of corporate traceability.

Here one can differentiate two scenarios:

A scenario whereby traceability extends to the immediate business partner network of customers,

suppliers & partners such as EDIFACT connections and Track & Trace portals as provided by Third party

logistics providers

A scenario whereby traceability is extended to a business partner network beyond first tiered business

partners and/or an entire value chain community (e.g. a potential network of EPCIS repositories that can

be looked up by a discovery service or a cloud-based value chain traceability community platform.

In external traceability scenarios, a well-defined concept of data access security related to the different levels

and different objects, as well as fast response time for external inquiries is of key importance.

1.

2.

29

Fig. 4: Differentiates internal traceability from two external

traceability scenarios


2.5 Deployment of internal and external Traceability

Furthermore, one can differentiate the accommodation of internal and external traceability with different

deployment models of their traceability infrastructures.

Fig. 5: Mapping of internal and external traceability example

domains to ‘On Premise’ and ‘On Demand’ solutions

31

3 SAP’s Track & Trace Solution Portfolio today

SAP Track & Trace solutions enable product, part, component and asset traceability from raw material to the

point of consumption with ‘On Premise’ solutions. SAP Track & Trace solutions, that can be integrated, support

product batch as well as item product/part serialized traceability, goods and assets in transit as well as trace-

ability for process monitoring and compliance.

Fig. 6: Solution Domains addressed by SAP’s Track & Trace

Solution Portfolio


» Product genealogy – links the genealogy of product batches, together with their relation to purchase or-

der, production order and delivery references into a complete corporate batch traceability solution. Trace-

ability into the Product (batch) genealogy can be realized with the saP global batch Traceability solution.

» item serialization & product traceability – helps to ensure secure distribution of products, prevent and

detect diversion and counterfeiting while complying with regulations and achieving full visibility of end-

product whereabouts and condition over their lifecycle. Item serialized traceability can be achieved with

saP object event repository.

» goods and assets in-Transit - improves transparency for goods in transit, including raw material supplies,

goods movements for production as well as the tracking of finished goods. This allows you to manage in-

transit inventory by exception instead of monitoring processes that are already in control. Furthermore,

allows tracking of assets/returnables as they move along the entire supply chain. Goods and Asset In-

Transit is accommodated by saP event management and can also be achieved through saP object event

repository.

33

» Procurement/Fulfillment Visibility – get transparency in your procure-to-pay or order-to-cash cycles by

using real-time status reports, which may span system or even company boundaries. This allows you to mo-

nitor procurement and respectively order fulfillment with greater granularity than within your ERP system

(e.g. by involving business partner information), and manage by exception instead of monitoring processes

that are already in control. Visibility scenarios can be implemented with saP event management, which

also serves saP object event repository as the core software component.

Combining these solutions offers a wealth of capabilities that support your organization in improving operati-

onal efficiency, reducing safety stocks, complying with regulations, reducing costly fire-fighting and improving

customer service to help you protect your brand. All solutions are offered with interfaces to SAP Business Suite

applications.


Fig. 7: SAP Track & Trace Solutions at a quick glance

Corporate Product Batch Genealogy

and tracking of related objects with

SAP Global Batch Traceability

“Trace” throughout product genealogy, Tracerelated objects such as deliveries, production and purchase order references, One click re-porting: delivery distribution, stock over-views, basis for material balances, Report processing of multiple batches in a single run.

Process, Asset and Transportation

Tracking with SAP Event Management

Management by exception, Visibility for or-der-to-cash / procure-to-pay cycles, Goods in-transit visibility, Process compliance.

Item serialized product traceability

with SAP Object Event Repository

Track & Trace throughout downstream distri-bution, Basis for traceability reporting to au-thorities. Corporate item serialized product, asset and component traceability across distributed business and sensor systems.

35

3.1 SAP Global Batch Traceability

SAP Global Batch Traceability is a new solution that is planned to be available by end of 2012. SAP Global Batch

Traceability allows for comprehensive graphical tracing of batch managed products and components and their

relationships throughout the supply chain network so that understanding the impact and possibly recall of a

flawed batch is greatly enhanced.

SAP Global Batch Traceability provides a corporate stand-alone repository that receives batch data as well

as related tracked objects data, from connected batch record systems.

Fig. 8: SAP Global Batch Traceability (SAP GBT)


A powerful search enables the quick understanding of corporate batch

genealogy for example, in the event of product issues:

Fig. 9: SAP GBT – Search Batches

With one click, it is possible to launch distribution and stock overview reports. It is also possible to customize

material balance reports with the selection of one or multiple batch IDs in a single run.

Thus, based on the faster insight provided, saP global batch Traceability:

» Reduces corporate liability risk associated with product issues

» Reduces the costs associated with product issue investigations and outright product recalls

37

It is possible to graphically explore the corporate batch network for

instance during the product investigation phase.

Fig. 10: SAP GBT - Traceability Network Graphic

» Increases customer retention rate and service levels by mitigating product issues

» Protects the brand by enabling quick reaction time in resolving product issues

» Helps comply with regulatory product issue reporting timelines

due to the release date of saP gbT by end of 2012 this booklet will

not focus on saP gbT.


3.2 SAP Event Management

SAP Event Management, as part of SAP‘s Business Suite SCM, provides visibility and the possibility to act on

processes, assets as well as performance along the entire supply chain by monitoring whether events happen

as planned or not.

SAP Event Management provides instance-level Tracking & Tracing for process monitoring, exception resolu-

tion, proactive alerting as well as operational & aggregated reporting.

Procurement and fulfillment visibility processes can be implemented concurrently, in order to get transparen-

cy in the procure-to-pay or order-to-cash cycles by using real-time status reports, which may span system or

even company boundaries. The solution allows the monitoring of procurement and order fulfillment with gre-

ater granularity than within your ERP systems (e.g. by involving business partner information), and to manage

by exception instead of monitoring processes that are already in control.

Another scenario that can be concurrently implemented is traceability for Goods and Assets In-Transit, im-

proving transparency for goods in transit including; raw material supplies, goods movements for production

as well as the tracking of finished goods. Furthermore, SAP Event management allows the tracking of assets/

returnables as they move along the entire supply chain.

as saP event management is from a technical point of view part

of saP object event repository this booklet will not focus on saP

event management.

39

3.3 SAP Object Event Repository

SAP Object Event Repository shares the SAP Event Management engine and database as its core repository.

This is complemented by SAP Auto-ID infrastructure, serving as a service engine component for encoding,

decoding and vocabularies as well as SAP NetWeaver Process Integration content for the EPCIS (Electronic

Product Code Information Service) interfaces. SAP Object Event repository is therefore, configured by an amal-

gamation of the software components; SAP Event Management, SAP Auto-ID Infrastructure and SAP Process

Integration content based on SAP NetWeaver.

With SAP Object Event Repository one can track and trace the event lifecycle of item serialized objects, their

related hierarchies, related batch data as attributes and the related business document context. The standard

content that SAP delivers for this is called product tracking & authentication – recently complemented by cold

chain monitoring extensions.

SAP Object Event Repository can serve as a corporate item serialization repository that receives data from

distributed Auto-ID systems or other systems that can map data to the EPCIS Capture notification message. In

Life Sciences, the SAP Object Event Repository may serve as a system of record for item serialized drugs and

be used as a basis for compliance reporting to authorities in the country-specific formats.


» 2-D barcoded as well as RFID-encoded serialized product items and their hierarchies can be tracked

together with batch Ids as attribute information for each item serialized product

» One can follow the event history of each serialized product item at any hierarchy level

» The corporate item serialized data store can be queried from the delivery context

» It is possible to capture requests for the status of external authentication requests for item serialized products

» SAP Object Event repository can be used for the lifecycle event traceability of item serialized assets, parts

and components – especially to track item lifecycle events across distributed systems and changes to

component hierarchies.

» The embedded event management capabilities of SAP Object Event repository also allow reaction to

events – by sending notifications to other systems or triggering workflows, in case an event is overdue or,

to deal with unexpected events.

With the right configuration and some custom extensions SAP Object Event Repository can be further leve-

raged for country-specific reporting. Manufacturers of healthcare products in particular are facing country-

specific legal regulations on serialization, aimed at combating counterfeiting, reimbursement fraud and illegal

trade. The constantly growing number of regulations imposes serious challenges to concerned parties to

achieve compliance while preserving process control & visibility.

In response to these requirements, SAP Object Event Repository (SAP OER) may be configured in a project for

regulatory compliance. Within this scope SAP OER may be used for:

41

» Handling the creation, transfer and acknowledgement of notifications to authorities

» Managing requirements of multiple authorities within one global solution

» Providing one central source of information, offering full visibility into the global process of regulatory

reporting

» Process control and exception resolution mechanisms (user approval, retriggering of notifications, alerting)

» Flexible configuration of notification types & characteristics to adapt to changing & newly issued requirements

This booklet will focus in some of the following chapters on saP

object event repository and saP auto-id infrastructure.

4 Scenarios as to how the Track & Trace domain may develop

In a global market place characterized by global opportunity as well as global competition, visibility of product

flows across their lifecycle are of key importance and may determine competitiveness.

Many companies are still working to achieve corporate or internal traceability but this will most likely be com-

plemented by external traceability in the future whereby products can be tracked and traced across a value

chain business network. Exemplary work attesting to this is for example; the GS1 Global Traceability standard

that defines different levels of traceability, their interconnections as well as internal and external traceability.

Past efforts were not futile as there has always been a concern about data sharing however, what if one only

shared elementary data? What would be the benefit/risk equation if one considers the capture of emergent

patterns and intelligence derived with traceability from an interacting network of value chain partners?


4.1 New technologies

Complete value chain traceability especially at highly granular resolution such as, at serialized level creates

huge data volumes. High-resolution traceability has great value but also poses information system challenges.

High resolution and value chain traceability create a valuable data pool that may be viewed from different

business contexts; for example from a sales, product lifecycle, audit, supply risk, pedigree and supply chain

status perspective to name but a few. However, to do this efficiently and also to allow ad hoc queries on this

wealth of data, new database technologies are needed. Such a technology may be provided by SAP HANA.

SAP HANA is a game-changing, real-time platform for analytics and applications. While simplifying the IT

stack, it provides powerful features like: significant processing speed, the ability to handle large data volumes,

predictive capabilities and text mining capabilities.

43

4.2 Value Chain traceability

Whilst internal traceability is typically realized through On Premise track and trace platforms – there is opport-

unity to address external traceability – i.e. traceability across a network of companies and consumers – in a

traceability cloud. Qualities of a traceability cloud may be elastic to data volumes, easy on boarding of network

partners, network connectivity rather than point to point connectivity and emergent value chain insights that

are being created in an emergent manner (i.e. patterns) out of the interactions and data in the cloud. Trace-

ability in such a cloud platform would be the core backbone relating product genealogy to various levels of

supply chain traceability (GTIN level, batch-level, serialized- level products, parts and assets, packing hierarchy

states, and configuration states). However, especially the value chain community services that would then leve-

rage the traceability data, would offer the value by providing insights into supply risks and reliability, alterna-

tive sourcing, compliance reporting, supply performance, sales performance, real-time visibility to the supply

chain status, integrate easily the consumer with mobile apps or web based services to gain new insights into

the product, for example provide confidence to users as to trusted pedigrees of products and so on.

44 GS1 Standards for Track & Trace

GS1 Standards for Track & Trace

iii

45

1 Welcome to the world of GS1 Standards - Managing complexity and ensuring compliance

GS1 published the “GS1 Global Traceability Standard for Healthcare” (GTSH) in February 2009. The GTSH is

based on the use of global, voluntary GS1 business standards. It includes a clear definition of traceability, esta-

blishes the minimum business model for traceability and describes the traceability process independent from

the choice of enabling technologies.

“Traceability is the ability to track forward the movement through specified stage(s)

of the extended supply chain and trace backward the history, application or location

of that which is under consideration”

For GS1, the term “Traceability” therefore includes the sub-processes of “Tracking” and “Tracing” as well as, for

example, enabling authentication (of the product identifier) and downstream reverse logistic sub-processes

such as product returns and recalls.

There is more than ever a need to agree upon and adhere to universal standards to manage product identifi-

cation and supply chain visibility. Standards are the foundation for clear, understandable exchanges between

supply chain partners in an increasingly complex supply chain.

GS1, an international not-for-profit association with Member Organizations in over 100 countries, is dedicated

to the design and implementation of global standards and solutions to improve the efficiency and visibility of

supply and demand chains globally and across sectors.

GS1 has over 30 years‘ experience in global standards. GS1 Global Office enables the Global Standards Ma-

nagement Process, managing a neutral forum that brings together hundreds of user-experts from various

sectors and countries and develops global standards to create a more efficient supply chain. GS1 Member

Organizations handle all enquiries related to GS1 Standards and provide related services.


2 How the Standards work

The GS1 System of Standards is the most widely used supply chain standards system in the world used in

multiple sectors, including consumer goods, healthcare, high tech, defense and chemicals. More than a million

companies execute more than six billion transactions a day.

GS1 Standards provide interoperable building blocks for an integrated system enabling traceability and visibility

in the supply chain.

The GS1 System of Standards is a flexible architecture built around and upon several elements:

» GS1 Identification Keys are the foundation of the GS1 System and ensure the globally unique identification

of products, locations, assets, etc. Identification Keys include for example GTIN (Global Trade Item Number)

and GLN (Global Location Number).

» GS1 Application Identifiers present a standardized way to encode additional information, such as expiry

date, lot number and serial number. A Serial Number is defined as being a variable length, up to 20 charac-

ters, alphanumeric field using Application Identifier 21 or AI (21).

» GS1 Barcodes provide a portfolio of data carriers, including GS1-128 linear barcodes, GS1 DataMatrix (two

dimensional bar codes) and others. For manufacturers, these meet the various needs including differing

pack sizes, amount of data and packaging/production rates. For users, these carriers can include all the

required data.

» GS1 EPCglobal uses Radio Frequency Identification (RFID) technology to electronically carry GS1 Identifica-

tion Keys in the Electronic Product Code (EPC).

47

» GS1 eCom enables electronic data interchange, providing clear guidelines for creating electronic versions

of all sorts of business documents in the order-to-invoice cycle, such as Purchase Order (PO) and Dispatch

Advice (DESADV), based on GS1 Identification Keys.

» GS1 Global Data Synchronization Network (GDSN) allows users to obtain, maintain, validate and exchange

master data in a secure and reliable environment via a network of GDSN-certified data pools. The syn-

chronized information (including GTIN, GLN and a defined set of product attributes (elements) empowers

electronic product catalogues.

» GS1 EPC Information Services (EPCIS) provides the ability to track and trace products as they move through

the supply chain, and includes a set of interfaces (capture and query) for obtaining and sharing data about

unique items both within and across organizations.

3 Traceability Models

A traceability system typically consists of the following building blocks, including unique identification, data

capture, links management, and data communication.

A number of models for traceability are emerging, for example, one up/one down, pedigree, point of dispense

authentication and distributed network Track & Trace. It is critical to consider regulations that may constrain

or determine which model is selected and implemented.

» one up, one down: In parallel to the physical flow of the product is the flow of data related to that product,

this is recorded and sent by “one up” party (e.g., manufacturer) to the “one down” party (e.g., Healthcare

provider) who also records it. The one up, one down flow may happen multiple times before the product

and data reach the end user/consumer.


Fig. 11: One-up, One-down Model

49

» Pedigree: A record, paper-based or electronic, containing information regarding each transaction resulting

in a change of ownership, change of custody or both. This may include sale by a manufacturer, acquisition

and sale by one or more wholesalers, manufacturers, re-packagers, or pharmacies/Shops, until final sale. A

pedigree should be maintained in an interoperable system, ensuring compatibility throughout all stages of

distribution.

» Point of dispense authentication: In general, authentication is the process of determining whether so-

meone or something is, in fact, who or what it is declared to be. The GS1 System Architecture provides the

mechanism for stakeholders to authenticate the GS1 Product Identifier (e.g. the Global Trade Item Number

(GTIN) in the carrier (bar code or RFID) through capturing data, transmitting data and communicating the

results.

» distributed network Track & Trace: In this model, parties who may have regulated, manufactured, bought,

sold, distributed, sent, received or repackaged product publish key data that is accessible by other parties

authorized to view the data in order to, for example, authenticate the product identifier, establish a products

pedigree or locate product for recall.


4 GS1 EPCIS

4.1 Introduction to GS1 EPCIS

» ePcis makes end-to-end supply chain visibility possible

EPCIS is a GS1 Standard for sharing real-time information about physical events in the supply chain between

trading partners. With the visibility provided by EPCIS, companies can improve their inventory management

by real-time tracking of their products, they can see where their shipments are stuck and if they have been

delivered, they can combat counterfeiting by identifying where products came from, etc.

» ePcis enhances business intelligence

EPCIS provides information about physical events concerning products and other assets in the supply chain.

It allows organizations to share data about the location of products or assets within their company and ac-

ross multiple stakeholders, making it possible to understand what actually happened in the physical world as

products and other assets were handled during operations taking place in factories, warehouses, retail stores,

and other facilities.

» ePcis documents real-life events

EPCIS data comprises a series of “events”. Each event documents at business-level something that happened

in the physical supply chain. Each EPCIS event has four dimensions of information:

WHAT (object identified by a GS1 Key)

WHERE (event location identified by an SGLN)

WHEN (date & time of event)

WHY (business context and object status)

51

» ePcis ensures that event data is understood

The Core Business Vocabulary (CBV) is a GS1 Standard that defines specific data values to populate the EPCIS

data model. This ensures that all parties who exchange EPCIS data have a common and consistent understan-

ding of the semantic meaning of that information. Thanks to this, EPCIS events are designed to be understood

by any business application, without the application needing to know how the process took place or how the

data was captured.

» EPCIS defines event-sharing interfaces

Besides defining the structure and meaning of physical visibility data, the EPCIS standard defines interfaces for

the secure sharing of EPCIS events between business applications and between trading partners.

The EPCIS Capture Interface specifies a standard way for business applications that generate visibility data to

communicate that data to applications that wish to consume it.

The EPCIS Query Interface specifies a standard way for internal and external systems to request business

events from repositories and other sources of EPCIS data.

» ePcis complements gs1 ecom and gdsn

By documenting supply chain events, EPCIS data complements other types of data exchange in the supply

chain, such as business transaction data (exchanged with GS1 eCOM) and master data (exchanged with GS1

Global Data Synchronization Network or GDSN).


» ePcis meets multiple industry requirements

The EPCIS standard has been developed to meet the requirements of multiple industries, from Consumer

Goods & Retail, Transport & Logistics or Healthcare. The EPCIS framework is extensible and therefore allows

industry-specific requirements to co-exist alongside the core components of the standard. This extensibility

allows for experimentation and new requirements development while still safeguarding interoperability.

» ePcis provides visibility on a “need-to-know” basis

A company implementing EPCIS can use the authenticated identity of a trading partner in conjunction with

pre-defined business rules to determine which information is made available to that partner.

business applications for ePcis include...

» Shipment Tracking

» Inventory Management

» Product Authentication

» Pharmaceutical Pedigree

» Electronic Article Surveillance (EAS)

» Promotion Tracking

» Product and food traceability

4.2 EPCIS - Bridging the physical flow and the information flow

Interfaces and protocols create a single way to capture and share information automatically and allow compu-

ters to communicate with each other, so processes can be automated.

Electronic Product Code Information Services (EPCIS) is a set of standardized network interfaces and protocols

for sharing supply chain data between supply chain partners. The What, Where, When, and Why of events

occurring in any supply chain is exchanged, safely and securely, via the EPCIS standard. The EPCIS standard provi-

des interface specifications built on top of very widely used business and Internet standards. And because they

53

are based on common Internet standards, companies can implement the standard in ways that work for them.

The EPCIS standard provides a way to share high volume, very fine grain information about material move-

ment and status among cooperating partners. EPCIS does not address purchasing, forecasts, bidding, billing,

etc. that are typically exchanged via EDI in a business transaction between two parties.

» data elements in the ePcis standard include:

WHAT - Product: It is possible to include any unique identity in the EPC field. The Electronic Product Code

(EPC) is designed as a universal identifier that provides a unique identity for every physical object anywhere in

the world, for all time. Its structure is defined in the EPCglobal Tag Data Standard, which is an open standard.

To ensure that an EPC always uniquely identifies an individual physical object, in the case of a GTIN, the EPC is

constructed as a serialized GTIN (sGTIN) by combining a GTIN product identifier with a unique serial number.

WHERE - location: ‘Read Point’ indicates the location where an event took place – e.g.: Distribution Center

X conveyor belt Y. ‘Business Location’ describes where the object is immediately after the event occurs – e.g.:

Distribution Center X, Shipping Area.

WHEN - Time: ‘Event Time’ states when an event took place. ‘Record Time’ indicates when the event was

received through the EPCIS Capture Interface.

WHY - business step and status: ‘Business Step’ indicates what business operation was taking place at the

time of the event – e.g.: Receiving, Picking, Loading, Shipping. ‘Disposition’ describes the status of the product

immediately after the event occurs – e.g.: Sellable, In Progress, Non Sellable, Destroyed.

It is possible for an end-user to build the EPCIS interfaces and data model themselves on top of an existing

enterprise system. But it may be simpler for many organizations to buy an EPCIS repository application from a

solution provider (e.g. SAP Object Event Repository from SAP), or obtain EPCIS-compliant application enhan-

cements from their existing application providers.


5 GS1 Standards in the pharmaceutical industry

5.1 GS1 Healthcare - Leveraging global standards to enable pharma traceability

The Healthcare sector today is facing one of the most serious challenges affecting the integrity of the supply

chain: Introducing traceability and serialization to increase visibility in the supply chain and fight counterfei-

ting. A multitude of regulatory initiatives worldwide responding to the threat of counterfeit medicines, risks a

significantly increased complexity for supply chain partners.

GS1 Healthcare, a global and voluntary user group, aims to lead the Healthcare sector to the successful de-

velopment and implementation of global standards in its supply chain. The user group was established in

2005, and although standards development work continues, it has built a solid foundation of global standards

available to the Healthcare sector. Local user groups in 30 countries have already launched national programs,

pilot projects and other initiatives to drive adoption and implementation in their country.

GS1 Healthcare allows users to interact with regulatory bodies and other stakeholders worldwide and to un-

derstand their needs. Those needs can be changed into solutions for the entire Healthcare sector. Hundreds

of expert volunteers participate in GS1 Healthcare work groups and meetings, representing all ‘sides’ of the

Healthcare supply chain and involving many supply chain leaders. (Twenty-two out of Healthcare Supply Chain

Top 25, a ranking by Gartner, a world’s leading information technology research and advisory company.)

55

5.2 Traceability in Healthcare - Regulatory developments

Government mandates is the main driver for traceability and serialization, for example in Brazil and Turkey.

More recently, serialization has received even more attention because of the activities of the US FDA and the

European Commission.

In Europe, the most important development is the Directive 2011/62/EU introducing obligatory safety features

to allow the verification of the authenticity of pharmaceutical products to prevent the entry of counterfeit

products in the legal supply chain. The European Commission is developing delegated acts that will set out

the details of this system, including the characteristics and technical specifications of the unique identifier, the

modalities for verification of the safety features and the repository system in which information on the safety

features is to be stored. The Commission is assessing the cost, benefits and cost-effectiveness that will be

based on the input during public consultation. The adoption of the delegated act is scheduled for 2014. The

directive needs to be transposed into national regulation in all European countries until 2016. Exempted from

this time line will only be Belgium, Greece and Italy, for them the deadline is 2022.

The european commission is raising fundamental issues in its concept paper for public consultation

(dd. 18/11/2011):

» Should individual manufacturers choose the appropriate technical solution for serialization or should the

European Commission regulate this and ensure harmonization?

» Should national reimbursement numbers be replaced with the new, harmonized serial numbers or should

they ‘co-exist’?

» What data carrier should be used: linear bar codes, 2D bar codes and/or RFID?

» When should the serial number be verified? Systematically at the point of dispensing? Random or systematic

verifications by wholesale distributors?

» Who is governing the repository system? Users themselves? An EU-body? National bodies of EU Member

States? There are a lot of questions to be answered but, serialization in Europe is no longer about ‘if’, but

‘when’ and more importantly ‘how’. Many pharmaceutical manufacturers are already considering how to

implement these important changes and have serialization projects underway, or are planning them.


The US Food and Drug Administration (FDA) is also looking into potential approaches toward a track and tra-

ce system for prescription drugs and has been obtaining input from supply chain partners on attributes and

standards for the identification, authentication and tracking and tracing of prescription drug packages.

In March 2010, the FDA published industry guidance on standards for securing the drug supply chain through

Standardized Numerical Identification (SNI) for prescription drug packages. It was the first of several regu-

lations and guidance documents that the FDA will issue to implement section 505D of the Food and Drug

Administration Amendments Act of 2007 (FDAAA), which requires FDA to “develop standards and identify and

validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted,

sub potent, substandard, adulterated, misbranded or expired drugs”. The SNI should be a serialized Natio-

nal Drug Code (sNDC), composed of the National Drug Code (NDC) combined with a unique serial number,

generated by the manufacturer or re-packager for each individual package. In line with GS1 Standards, serial

numbers should be numeric or alphanumeric and should have no more than 20 characters. This alignment was

recommended in many of the comments submitted in response to the FDA’s Request for Comments. FDA has

also further considered compatibility with GS1 Standards. The use of an sNDC is compatible with, and may be

presented within, a GTIN, which can be serialized using an Application Identifier (AI) (21).

Several other national regulatory bodies have already developed similar requirements or are looking into a

traceability initiative. For example, ANVISA, Brazil’s regulatory body has issued guidance for a traceability sys-

tem for medicines in the country. Earlier guidance required the use of a security seal, but this has now been

replaced with the requirement for serialized 2D bar codes printed directly onto secondary packaging, in line

with global developments. ANVISA will manage the national repository of serial numbers. ANMAT, the Argen-

tinian Food, Drug and Technology Administration, will launch a new drug traceability system that will allow

pharmacies, health centers and patients to verify the drug in real time. According to the 3683/2011 Regulation,

suppliers should place a code on their packaging complying with GS1 Standards.

57

GS1 Healthcare maintains a global, online repository of regional and country regulations, directives and guide-

lines relating to requirements for Healthcare product identification, product catalogues and traceability. Infor-

mation introduced in the database is compiled on the basis of information received by staff of the worldwide

network of 108 GS1 Member Organizations (MOs) and members of the global GS1 Healthcare community, or

information received directly from governmental bodies and regulators issuing the requirements, guidelines

and regulations.

6 Advancing a unified approach

There is momentum in the Healthcare sector to implement serialization, not only to comply with existing and

developing regulations, but also to drive value. There is also momentum to adopt global, user-driven stan-

dards to effectively and efficiently implement traceability solutions. The GS1 System of Standards provides

a foundational framework to meet this challenge and manage inconsistencies in legislation, regulation and

resources existing from country to country.

for more information about gs1 healthcare, visit

www.gs1.org/healthcare

58 Drivers of Track & Trace

Drivers of Track & Trace

iv

59

1 Legislations

As implied several times in this booklet Track & Trace

is still a very legislation driven topic. Investments are

high and offsetting this only with business benefits,

which are gained due to the better transparency

in the supply chain is hard to achieve. Therefore, it

is worth mentioning the most common industries

with legislations/regulations in place.

These are primarily the pharmaceutical industry,

followed by the tobacco and explosives industry.

Beside these industries, there are certainly other

regulatory requirements and it is highly likely that

there will be much more in future. Due to the rapidly

changing nature of legislation, the focus of this

chapter will be the three key industries stated.


Fig. 12: Pharma Serialization Deadlines3

1.1 Pharmaceutical Industry

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Drivers of Track & Trace

Questions asked

A) deadline date

(If applicable. If country already serialized,

simply state ‘current’)

B) method of serialization

(E.g. 2D Datamatrix, RFID, linear barcodes,

e-pedigree, etc.)

C) any additional restrictions or requirements?

(E.g. special labels? Where from? Etc.)

D) level of serialization required

(E.g. country, lot, package, etc.)

63

Argentina

A) 15.12.2011

B) 2D, The Health Authority does not give any specific recommendation. The laboratories

could choose between optical technologies (Datamatrix & GS1-128) or RFID EPC, Not

fixed. GS1 standard. (Bar code, Datamatrix or RFID) Preferred: Datamatrix

C) Security labels are required. The labels used must leave marks when removed. Visual

code in the label.

D) GTIN + SERIAL

Belgium

A) Current

B) 2D - Sequential Barcode, 1D barcode Code-128C, linear barcode

C) Special Labels - IPEX, Labels applied by “Vignette labeller”

D) Package number lot info, GTIN, lot, exp., Serial nr, Package, reimbursed medicines

Brazil

A) January 2012 (Please note: this is being contended and may change - TBC)

B) 2D as per GS1

C) Additional tamper evident label to seal carton, auto-adhesive labels with the 2D code

D) Package, secondary and tertiary packages

California

A) 50% of product by Jan 2015 and 50% by Jan 2016

B) E-Pedigree, 2D Datamatrix, RFID, Linear

C) X

D) Item, smallest saleable unit, every level of packaging, Saleable unit point of sale,

e-pedigree, full track and trace


China

A) 2015, although some started April 2010

B) 128 Barcode

C) Need to obtain barcode from Government

D) X

Germany

A) As per EU Directive; National legislation by Jan 2013, enforced by Q4 2016

B) 2D Datamatrix

C) Pilot project to be run in 2013 to decide widespread implementation strategy

D) Likely to be package level

France

A) As per EU Directive – possible extension to 2022 pending

B) 2D Datamatrix, 2D required for CIP code

C) GTIN, lot, exp., Serial nr

D) X

Greece

A) Ongoing

B) Bollini Label 1D barcode: Code-39, linear barcode

C) Labels applied by “Vignette labeller”

D) GTIN, lot, exp., Serial nr, Package, reimbursed medicines

65

India

A) Not applicable, only Expiry Date required, Primary level Packaging: 1/07/2012, Secon-

dary Level Packaging 1/01/12, Tertiary Level Packaging 1/10/11

B) Method of RFID, 2D Barcodes. Change only one tag FDA (Green/Approval). 2D or 1D

barcode as per GS1. Primary level Packaging: GS1 2D DataMatrix, Secondary Level

Packaging: GS1-128 i.e. 1D or GS1 DataMatrix i.e. 2D or GS1 Databar, Tertiary Level

Packaging: 1D Barcode (GS1-128). 2D Datamatrix

C) No more Tag/Details: of prescription drug packages. Unique serial number, product

identification code, batch number and expiry date

D) FDCA: For Domestics not for Export: chain of approval from all dealers, doctors and

pharma authorization. Every packaging level. As per DGFT notification.

Italy

A) Ongoing

B) Bollini Label 1D barcode: Code-39 (2D under discussion)

C) Labels applied by “Vignette labeller” purchase of Bollini from Italian MoH

D) GTIN, lot, exp. Serial nr, Package related to Batch Id

Nordic Countries

A) As per EU Directive

B) X

C) X

D) GTIN, lot, exp., Serial nr


Russia

A) 2015, current

B) Linear, 1D barcode Code-128C

C) Serials provided by Government (not GS1-compliant)

D) Serial nr, every packaging level

Scandinavia


B) 2D Datamatrix

C) X


Spain

A) 2016, Pilot project finished

B) Datamatrix (pending Delegated Acts in EU Directive &

their transposition into Spanish laws)

C) All reimbursed medicines

D) Unit/package level

67

UK


B) 2D Datamatrix

C) X


USA

A) 2015-16 on some pharma

B) E-pedigree, 2D as per GS1, e-ped (RFID or barcode)

C) Possibly (if RF then encoding important)

D) Sales pack, Lot – Potency, Expiration - NDC -eProduct Code - Manu

- DC/Pharmacy – UID


1.2 Tobacco Industry

The WHO Framework Convention on Tobacco Control (WHO FCTC) is the first treaty negotiated under the

auspices of the World Health Organization. The WHO FCTC is an evidence-based treaty that reaffirms the right

of all people to the highest standard of health. The WHO FCTC represents a paradigm shift in developing a

regulatory strategy to address addictive substances; in contrast to previous drug control treaties, the WHO

FCTC asserts the importance of demand reduction strategies as well as supply issues.

The WHO FCTC was developed in response to the globalization of the tobacco epidemic. The spread of the

tobacco epidemic is facilitated through a variety of complex factors with cross-border effects, including trade

liberalization and direct foreign investment. Other factors such as global marketing, transnational tobacco

advertising, promotion and sponsorship, and the international movement of contraband and counterfeit ciga-

rettes have also contributed to the explosive increase in tobacco use.4

The who fcTc also regulates the illicit trade in tobacco products

in Part iv, article 15 in the ‘who frame work convenTion on

Tobacco conTrol’. following is an abstract of article 15:

1. The Parties recognize that the elimination of all forms of illicit trade in tobacco Products, including smugg-

ling, illicit manufacturing and counterfeiting, and the development and implementation of related national

law, in addition to sub-regional, regional and global agreements, are essential components of tobacco

control.

2. Each Party shall adopt and implement effective legislative, executive, administrative or other measures to

ensure that all unit packets and packages of tobacco products and any outside packaging of such products

are marked to assist Parties in determining the origin of tobacco products, and in accordance with national

law and relevant bilateral or multilateral agreements, assist Parties in determining the point of diversion and

monitor, document and control the movement of tobacco products and their legal status. In addition, each

Party shall:

1.

2.

69

(a) Require that unit packets and packages of tobacco products for retail and wholesale use that are sold

on its domestic market carry the statement: “Sales only allowed in (insert name of the country, sub

national, regional or federal unit)” or carry any other effective marking indicating the final destination

or which would assist authorities in determining whether the product is legally for sale on the domestic

market; and

(b) Consider, as appropriate, developing a practical tracking and tracing regime that would further secure

the distribution system and assist in the investigation of illicit trade.

3. Each Party shall require that the packaging information or marking specified in paragraph 2 of this Article

shall be presented in legible form and/or appear in its principal language or languages.

4. With a view to eliminating illicit trade in tobacco products, each Party shall:

(a) Monitor and collect data on cross-border trade in tobacco products, including illicit trade, and ex-

change information among customs, tax and other authorities, as appropriate, and in accordance with

national law and relevant applicable bilateral or multilateral agreements;

(b) Enact or strengthen legislation, with appropriate penalties and remedies, against illicit trade in tobacco

products, including counterfeit and contraband cigarettes;

(c) Take appropriate steps to ensure that all confiscated manufacturing equipment, counterfeit and cont-

raband cigarettes and other tobacco products are destroyed, using environmentally friendly methods

where feasible, or disposed of in accordance with national law;

(d) Adopt and implement measures to monitor, document and control the storage and distribution of

tobacco products held or moving under suspension of taxes or duties within its jurisdiction; and

(e) Adopt measures as appropriate to enable the confiscation of proceeds derived from the illicit trade in

tobacco products.

4.

3.

4 WHO Framework

Convention on Tobacco

Control


5. Information collected pursuant to subparagraphs 4(a) and 4(d) of this Article shall, as appropriate, be provi-

ded in aggregate form by the Parties in their periodic reports to the Conference of the Parties, in accordance

with Article 21.

6. The Parties shall, as appropriate and in accordance with national law, promote cooperation between nati-

onal agencies, as well as relevant regional and international intergovernmental organizations as it relates

to investigations, prosecutions and proceedings, with a view to eliminating illicit trade in tobacco products.

Special emphasis shall be placed on cooperation at regional and sub-regional levels to combat illicit trade

of tobacco products.

7. Each Party shall endeavor to adopt and implement further measures including licensing, where appropriate,

to control or regulate the production and distribution of tobacco products in order to prevent illicit trade.5

7.

6.

5.

5 WHO Framework

Convention on Tobacco

Control - http://whq-

libdoc.who.int/publica-

tions/2003/9241591013.pdf

6 FEEM European Explosives

Code Structure - http://

www.tt-e.de/download/

Guidance%20Note%20

on%20the%20FEEM%20

European%20Explosives%20

Code%20Structure.pdf

71

1.3 Explosives

Regulatory requirements in the explosives industry are regulated in the “European Directive 2008/43/EC on

Identification & Traceability of Explosives for civil uses”.

» in the following an abstract of the ‘feem european explosives code structure’:

This FEEM (Federation of European Explosives Manufacturers) Guidance document has been prepared to out-

line the method adopted by FEEM Members to achieve a harmonized system for the purpose of implementing

the European Commission’s Directive 2008/43/EC to establish “a system for the identification and traceability

of explosives for civil uses”, and the associated national legislation. The system being recommended is not bin-

ding on any FEEM Members, but the adoption and adherence to it shall minimize logistical problems throug-

hout civil explosives supply chains in Europe. It is also available for others to adopt should such as system be

seen as beneficial.

The European Directive on Identification & Traceability of explosives came into effect on the 4th of April 2008.

This directive is intended to establish a harmonized system for the unique identification and traceability of all

packaged explosives, detonators, reels of detonating cord, primers and other explosives used in civil appli-

cations across the European Union. The directive was adopted into the national legislation of each European

Union member state on 5th of April 2009 with compliance achieved throughout Europe by the 5th of April

2012. The requirements of the Directive apply to all explosives manufactured, used and imported into the Eu-

ropean Union from 5th April 2012.

The European legislation states that all packaged explosives for civil uses must be uniquely identified and

tracked at every stage throughout its life cycle. This requires every explosives cartridge, detonator, detonating

cord (every 5 meters), reel of detonating cord, and primer to have a visibly readable unique number on a label,

with a barcode or RFID tag, and an associated data capture/recording/reporting system. It is also a require-

ment for the records of every uniquely identified article to be maintained and to be available for inspection

for a period of 10 years.6

72

Fig. 13: Big Picture: Potential benefi ts of Track & Trace

72

73


73



2 Beyond compliance: potential benefi ts of Track & Trace

Setting up an item serialization infrastructure from scratch is always very cost intensive and disruptive and

most companies would only do it if they have very good reasons to do it (patient safety, compliance etc.)

However, putting a Track & Trace infrastructure in place in addition to pure item serialization is even more

disruptive and requires not only technology on the packaging lines, but lots of change management within

the entire supply chain.

For this reason, the ‘Million Dollar question’ is always: how can we leverage our Track & Trace investment?

As the reader can derive from the diagram above, there is no simple answer to the question. There are many

opportunities to gain benefi ts out of Track & Trace, however which of those become real tangible gains stron-

gly depends on the following factors:

What are the process requirements in order to achieve the benefi t?

What are the data requirements?

Subsequent sections of this chapter are aimed at providing some guidance to the reader. The insights and

inputs are the results of many workshops, discussions and analysis conducted mainly with multinational cor-

porations from predominantly pharmaceutical industries, tobacco, agrochemicals or chemical industries.

1.

2.

See Fig.13 on

page 72-73

75

2.1 Improved operations

The opportunity to improve operations mainly results from the following:

2.1.1 Process standardization and harmonization

Running a Track & Trace project always means going back to the manufacturing plant and warehouses or

distribution centers and introducing new processes in order to scan IDs on goods receipt, good dispatch, de-

structions and any changes in the aggregation (Pallet-case-bundle-item). Those processes are in most cases

(even though the particular country legislations might differ significantly) very standard and homogenous

across all warehouses and plants. Thus, if embedded in current processes, they represent a clear opportunity

of standardizing operational procedures and harmonizing processes.

The global IT and Supply Chain teams are the main beneficiaries of standardized processes and operations,

as it makes it significantly easier for them to support different countries and deploy new practices and tech-

nologies.

The process pre-requisite to realize this potential benefit, is to “build in“ Track & Trace processes within supply

chain processes. Although this is not always practical due to timelines pressure (e.g. legal compliance driven by

a given market could make it impossible to run an exhaustive change management program), it should always

be the long-term vision of any global corporation to put Track & Trace in place. In many instances corporations

put Track & Trace on top of current processes and design a long-term roadmap to move from “on top“ to

“built-in“. This kind of transition roadmap has been observed to be the most efficient and risk free approach

to implement Track & Trace across the supply chain. The alternative, to place integrated processes everywhere

from day one, tends to have very high failure rates, running into escalations and high impact operations pro-

blems (e.g. deliveries could not go out because Track & Trace process or technical failure).


2.1.2 Gain production performance KPIs

Even with pure item serialization (comprehensive Track & Trace not required) it is possible to gain more in-

sights into the production performance as individual items are produced, read and recorded on each of the

packaging lines. In this way it is possible to have a 100% accurate rate of packaging line performance, rejec-

tions etc. Obviously the gain derives not so much from the KPI itself but from the actions taken as a result of

the KPI analysis.

The factory manager is the main beneficiary of gaining KPI data from the packaging lines. Based on this data;

maintenance, purchase and other strategic decisions can be taken.

There are no process requirements in order to convert this potential into a benefit. The required numbers for

the KPI calculation are usually recorded automatically; there are however data requirements as a KPI reporting

system needs to be linked to the Track & Trace system in order to obtain the desired KPIs.

2.1.3 Gain warehouse performance KPIs

An obvious potential in cases of comprehensive Track & Trace deployments, in which the operators need to

scan nearly everything as a part of daily operations, is gaining transparency in warehouse performance as a

whole and taking it further, and also gaining insights into the individual operator performance. This kind of

transparency however is not always desired, and very frequently, especially in European countries with strong

trade unions and large social considerations, this is often an unacceptable practice, and almost taboo; as a

result scanning mobile solutions treat users as anonymous (without any personal logins etc.) in order to avoid

the corporation from deriving operator performance KPIs through the scanning activities in warehouses or

manufacturing plants.

77

The warehouse manager and on a higher level, the head of logistics in the country or region is the main be-

neficiary of gaining KPI performance data from the warehouses.

As was the case for the production performance KPIs, there are no process requirements in order to convert

this potential into a benefit. The required numbers for the KPI calculation are usually recorded automatically;

there are however data requirements as evidently a KPI reporting system needs to be linked to the Track &

Trace system in order to obtain the desired KPIs.

2.2 Competitive advantage

When we first started working in the Track & Trace space, back in 2006, we were surprised by the high degree

of collaboration between directly competing corporations when it came to Track & Trace implementation.

We have even observed how industry wide working groups were formed across verticals in order to share

knowledge, establish best practices and even reuse IP and software solutions (good examples are the tobacco

industry working group or the CRISTAL working group from the agrochemicals industry). The only reason for

this was that Track & Trace was perceived as a non-value adding “must have”; something that must be done

for compliance, costing large amount of money and not bringing any competitive advantage.

In recent years however, we have noticed a paradigm shift in this perception. Although the collaboration

around technicalities is still on going, companies are starting to leverage the existing investments to go bey-

ond compliance. In industries like pharmaceutical or agrochemicals (less in tobacco due to legal restrictions in

terms of consumer facing marketing activities) we see great interest in areas that create customer value added

services. Examples are:


2.2.1 Customer consumption, alerts, monitoring

The most common example is mobile apps for the end customer that assists medicine or product consump-

tion. In pharmaceutical mobile apps, corporations are starting to link Track & Trace data with consumption

profiles, alerting consumer about medication, and monitoring dosage consumption etc. (assuming the patient

scans every medicines pack bought before consumption).

In the agrochemical industry the materialization of those customer added services also come in the form of

mobile apps, such that once deployed, the consumers are able to advise on quantities to put in fields, calculate

bend formulas based on expected weather forecasts for a given location (based on device coordinates) etc.

2.2.2 E-Leaflets and targeted illness or product info

Driven by Track & Trace, but not necessarily linked to this (as Track & Trace is not really required to provide tho-

se services), are those mentioned customer friendly apps usually containing more additional functions which

allow the patients to scan the medicine ID (not necessarily the unique ID) and display the electronic leaflet

(what we call the e–leaflet) or receive some additional information about the illness for which the medicine is

being taken (a sort of electronic flyer, which would normally be acquired in the pharmacy or from the doctor,

explaining the illness and ways of combating it etc.).

2.2.3 Increased customer loyalty

For lifestyle drugs (less prescription drugs), the luxury goods industry or for other industries where products

are more commoditized (like agrochemicals, electronics, beverages etc.) we participated in several projects

with the mission of linking Track & Trace to loyalty programs.

79

A good example of this is the ‘Bonusland’ program launched by Syngenta for the German market in 2010; a

program that allows farmers who bought Syngenta products (all products containing random serial numbers)

to collect unique ID labels (the 2D data matrix could be extracted from the bottle) and exchange the collected

labels for rewards. The publicly accessible documentation for this project is available on YouTube (search for

Syngenta ‘Bonusland’).

The reason for integrating Track & Trace with loyalty programs is normally to ensure that any unique ID re-

ceives points only once (as the numbers are unique), and that only real IDs are awarded (hence, the unique

numbers have to be randomized and cannot be sequential).

2.2.4 Establishing a direct dialog with consumers

This is all about crossing the bridge to the consumers; thanks to the previously mentioned services, manufac-

turers from any industry are in the position to establish a direct dialog with consumers and patients. Even in

industries where the consumer might have to stay anonymous for legal reasons (e.g. patient protection laws

in some countries) this direct dialog has a great marketing value for producing companies. In the past the

only channel to the consumers was via wholesalers/retailers. This new channel brings a whole range of new

opportunities.

From all the mentioned value added services, Marketing managers are typically the main beneficiaries of gai-

ning this new channel to the end consumers.

Requisites in order to exploit these opportunities by gaining the required data are: building the consumer mo-

bile app and linking it in with the Track & Trace system, with the loyalty/CRM systems or with whatever other

systems required (e.g. weather forecast databases).


However, the real benefit is not in collecting the data, but in acting on this data (cross selling, up selling,

profiling etc.). Therefore, there are process requirements in order to ensure that the marketing department is

capitalizing on the benefit of gathering all this additional data. Those processes are always by their nature very

customer specific and normally subject to confidentiality (as this is effectively what creates the competitive

advantage).

2.3 Better Waste Management

Scanning scrapped/decommissioned products whenever single items are taken out of the supply chain is

normally compulsory for a company that puts Track & Trace in place (even in simple item serialization scena-

rios this is a must). This small process change has the potential to add additional gains to any corporation

in terms of:

2.3.1 Waste statistics (Intelligence)

Knowing exactly which items, when and for what reason were decommissioned (e.g. quality sampling or pro-

duct expired) and having this information in a global centralized database can be of great value especially for

supply chain managers (allowing central monitoring of warehouse waste) or to quality managers (documen-

ting the entire size of samplings etc.).

The data requirement means that the central Track & Trace repository is able to provide a report of decom-

missioned items per location.

81

2.3.2 Avoid waste to revert to Supply Chain

The greatest benefit is for the patient or consumer, and of course for the quality manager within the corpora-

tion, because flagging every decommissioned product in the Track & Trace database and offering the corre-

sponding look up/verification services to consumers can avoid waste product from being re-introduced into

the supply chain and be consumed.

In order to gain this benefit the data requirement is that a corresponding verification service is accessible to

the end consumer via a mobile app, internet website or pharmacy Point of Sale (PoS) integration during dis-

pensing etc.

2.4 Visibility in parallel trading

Parallel trading is very frequently an illegal practice in many industries, especially in those in which additional

import/export taxes are added to the product price (e.g. tobacco or alcohol). In the tobacco industry for ex-

ample parallel trading (thus, avoiding tax evasion) is the main driver for governments to enforce Track & Trace.

In other industries such as pharmaceuticals, parallel trading however is partially legal, like in the EU, where free

trading of goods allows many re-packagers to run very lucrative businesses by purchasing drugs in Greece

and re-packaging them for the UK market. Parallel trading is however not legal outside of the EU (e.g. drugs

purchased in EU cannot be legally imported into the US).

Even though it is not widely acknowledged, especially in the pharmaceutical industry (despite parallel trading

being encouraged by governments based on the free trade of goods principle) Track & Trace is without ques-

tion a very useful instrument to gain insights in parallel trading activities from wholesalers.

Again the supply chain manager is the main beneficiary. The main requirement to realize this benefit is to be


able to gather feedback from the market on a given ID. Thus, whenever an ID is dispensed, this ID needs to

be validated against the Track & Trace repository. With the corresponding alert mechanism in place, it is then

possible to identify the first purchaser of this item and the country in which the item was intended to be sold.

2.5 Avoid brand damage

For any marketing responsibility the worst possible nightmare is when a consumer dies or is injured due to the

consumption of expired, defective or counterfeit product. But even in less extreme cases (e.g. in the luxury

goods industry) the image of your products can be seriously damaged by falsified copies sold as the genuine

one but obviously qualitatively inferior as the original product. In other industry, like in the cars or machinery

spare parts industry, the problem is not even the quality of the falsified products, but the fact that this results

in revenue losses. The most common benefits in most industries can be summarized as:

2.5.1 Avoid consumption of recalled batches

Provided that items belonging to defective batches (and therefore recalled) are flagged in the Track & Trace

database as “recalled” and provided that the corporation offers its customers some means for verifying the

product before its consumption, the usage/consumption of items belonging to re-called batches can be easily

avoided.

83

2.5.2 Avoid anti-counterfeits

Provided that the end consumer is able to verify a given product ID, (and that this product ID contains authen-

tication features in addition to plain unique printed randomized numbers) any consumer will be able to verify

the authenticity of a given item before its consumption.

2.5.3 Avoid consumption of expired product

Provided that the expiration date is an attribute of each unique item in the Track & Trace database, and as-

suming that the corporation offers to its customers a means of verifying the product before its consumption,

(e.g. during product dispensing at pharmacies, via mobile apps or internet etc.) the usage/consumption of

expired items can be avoided; although, in most cases, expiration date is printed in human readable format on

the item packaging thereby adding an additional alert for the end consumer.

2.6 Improved recall Management

Batches can be recalled for different reasons but the most common is the detection of faulty ingredients within

a given batch. In this case, neither item serialization nor Track & Trace help to identify which batches are affec-

ted; this requires tracking of raw materials and product and complete product genealogy tracing (tracing all

materials purchased, consumed, manufactured, and then distributed in the supply network).

However, once the affected batch is identified, Track & Trace helps to find out in which storage locations, who-

lesalers and retailer’s stocks the affected batch exists.

In the event of a batch recall, the quality manager and supply chain director in charge of the recall campaign

are the main stakeholders. The most common derived benefits resulting from the improved batch recall ca-

pabilities are:


2.6.1 Faster and partial batch recalls

Having a global Track & Trace system that contains serialized item information (in which typically each unique

item has the batch Nr. attribute populated) and provides reporting capabilities using Batch Nr. as a filter (and

groups the resulting items by location) would allow the execution of a batch recall much faster than usual,

since normally such a central system does not exist. In reality, most companies today require lock ups in several

systems in order to be able to consolidate all required information to initiate the recall campaign. Also, partial

batch recall might be something useful in given circumstances.

2.6.2 Faster version replacement

In particular, the pharmaceutical industry has regulations around product instructions, packaging, information

and artwork and related updates (medicine leaflets) that are very prescriptive. In many cases, even though a

given batch might not have any quality related issue, if it contains an older version of a leaflet or of the art-

work, the given batch supplied to a given market needs to be retired from the market. Thanks to Track & Trace,

in future, it would be possible to improve the management of versions and its stocks.

2.6.3 Theft stocks recalls

With non-serialized products, in the event that genuine product is stolen, it becomes quite impossible to

identify during trading exchanges in the supply chain or during its later consumption. Thanks to Track & Trace,

any stolen product IDs (given that each product ID is a unique number) can be flagged as stolen and later be

identified by inspectors, quality managers or trading partners.

85

2.7 Shipment visibility and alerting

Whenever Track & Trace is implemented (not the case if only item serialization is in place), any warehouse

operator needs to scan individual items (or hierarchies of items) during receiving, shipping, aggregation or de-

aggregation operations. Two side effects of these scanning activities are potential opportunities to generate

benefits for any warehouse manager or supply chain manager.

2.7.1 3 PL performance measurements

If Track & Trace is required, scanning operations are also required in outsourced operations. Due to this fact

it is relatively simple to compare work performance between different 3PL partners, and so review existing

contracts or agree on measures to boost productivity and efficiency.

2.7.2 Error-free pick & pack

Probably the most apparent benefit of integrating Track & Trace in the current logistics operations is to avoid

errors during picking and packing and ultimately wrong shipments. Usually, warehouse operators only confirm

quantities during delivery processes (whenever an SKU is packed to fulfill a delivery, the operator manually

confirms the quantities of the delivery line items after a visual counting procedure). With Track & Trace, an

automatic confirmation of quantities takes place instead of a manual one. As a result, deliveries containing

Track & Trace relevant products can only be completed if all the correct items with the correct SKU and batch

combinations were scanned in the exact quantity as expected in the delivery. Clearly a very low error quote

increases customer satisfaction and decreases error handling related costs.


2.8 Optimized Inventory

Optimized Inventory is one of the key principles of the lean enterprise (very widely considered a best practice

in manufacturing companies). To the greatest possible extent, the following will be maximized: just in time,

first in first out, produce to order and possibly working capital and ‘out of stocks’ can be minimized. Optimi-

zing inventory is usually a project in itself, frequently not related to Track & Trace. With Track & Trace however,

because a central repository for individual items is usually created, it is possible to build on top of this, the

dream tool of any supply chain manager: a real time global inventory monitor. In order to achieve a strong

reporting tool, a connection to the items repository is required. Furthermore, the raw data exist, it is global

and it is extremely granular (on item level). The following points below are just some of the examples that this

global inventory monitoring could offer in terms of functionality:

» Updated planning process with actual lead times

» In-transit inventory

» Reduce & stabilize lead time

» Multi-stage inventory (Safety stock)

In any case, achieving these benefits requires that the corresponding reports are built. This however, does not

imply changes to processes, as the data is available and collected as part of Track & Trace operations. It is only

a question of providing different views and perspectives of the existing Track & Trace data.

87

2.9 Additional aspects to consider

There are additional advantages that can be gained from full item traceability, which are not shown on the

graphic at the beginning of this chapter. An interesting aspect for example is sustainability.

Traceability is one key pillar for sustainability

Much of today’s sustainability data recording is a somewhat fuzzy exercise, apportioning through statistics or

averages of for example energy consumption of products.

With the right traceability system as backbone, the product genealogy, downstream traceability and product

provenance data could be attributed with product footprint data such as energy and/or water consumption

actually used in each production step. Actual natural resource consumption data across a product’s lifecycle

can be recorded from raw material till the point of sale. Emission calculations or measurements could be in-

tegrated as well.

Traceability to support sustainability strategies and its associated data recording will increase in importance

to support the maintenance and building of brand image, especially as resources become scarcer. In that

sense, traceability not only serves supply chain management or distributed manufacturing or the compliance

to traceability directives but also helps support corporate sustainability strategies. And ideally, a corporation

and their value chain partners have a single harmonized traceability data set that provides a single traceability

DNA supporting the different Supply Chain Management (SCM), Manufacturing, Quality Management (QM)

and sustainability context views.

88 Software components for Track & Trace and their features

Software components for Track & Trace and their features

v

89

1 Requirements for Track & Trace Software Components

1.1 Introduction

In recent years, an entire industry providing Track

& Trace solutions to businesses has arisen. Track &

Trace systems include both hardware and software

components. In this booklet the primary focus will

be on the software components required to set up

a Track & Trace solution.

The principal software components are described in

more detail in subsequent chapters. In order to get

a better understanding of the features, which will be

described later, the requirements for Track & Trace

software components will be addressed first. The

best way to do this is to start with a simple example,

describing the single process steps and the require-

ments they generate for the software components.

91

Fig. 14: Overview Track & Trace process steps


1.2 Process example to explain the software requirements

1. Track & Trace in the production

Process step 1: Production

Physical: The products are produced

System: This process is not yet managed by Track & Trace software components. In general, the production

and packaging lines are connected to a Manufacturing Execution System (MES) in order to guarantee better

transparency and control.

Process step 2: application of the storage medium

Physical: The storage medium (RFID transponder, 1D-, 2D barcode) is inscribed with the unique serial number

(e.g. EPC) and further data may be applied to the products and packaging containers (e.g. boxes, shippers,

pallets, etc.). This normally happens during production/packaging process. In general, the medium is checked

before it is applied to the product.

System: At this stage 4 necessary Track & Trace components are apparent. There has to be a global Track &

Trace repository (in regards to GS1 standards = EPCIS System), which at this stage contains all replicated pro-

ducts from the backend system and the associated GTINs (Global Trading Item Number). A so-called consoli-

dation system (which can have different functions, at least if it comes to the SAP product which is described

later in this booklet and which in regards to GS1 standards is called edge server) manages the local number

ranges (e.g. per production plant). The software system on the production line (e.g. Systech, PCE, Werum,

Seidenader, etc.) that generates the RFID or barcode labels calls up a web service and automatically requests

new number ranges from the site manager/consolidation system. It is therefore ensured that labels can be

created without interruption, although the serial numbers are managed on the global software level (EPCIS

System). And finally the printing software/technology at the production lines, to print the storage medium

in cases where on-line printing is used.

1.

93

Process step 3: creation of Packaging hierarchies

Physical: In this process stage, outer packaging is applied to the individual products. By allocating individual

products to an outer packaging, a packaging hierarchy is created. In further process stages, it is then sufficient

to read only one label from this container in order to identify all of the corresponding products.

System: The software system on the production line notes the relationship between the individual products

and the outer packaging. As soon as the complete packaging hierarchy has been generated (e.g. after the

outer packaging’s have been palletized), this information is passed through the edge server (if there is one)

to the global Track & Trace repository (e.g. EPCIS System). Multi-level hierarchies are of course possible,

e.g. items in folding boxes, folding boxes into shipping boxes, shipping boxes on pallets. Some important

attributes of the individual products, e.g. batch, expiry date, lot size, etc. are also carried over and can now be

retrieved at any time for each individual product.

Process step 4: loading the goods for Transport

Physical: The pallets are loaded e.g. onto a truck for transporting to the next station in the supply chain.

System: Each pallet has its own label, by means of which it is clearly identifiable, e.g. with a SSCC (Serial Ship-

ping Container Code). From the pallet label, the complete hierarchy of the pallet and the attributes of each

individual item can be queried in the global Track & Trace system. While loading the truck the individualized

pallets are scanned by a mobile scanning solution. Due to the scanning process two things will happen; the

automation of the goods issue posting will be triggered in the backend system using a system providing the

necessary logic and rules framework (e.g. the edge server) and a “shipping” event will be stored for each

individual item on the pallet with a time stamp and related location in the global Track & Trace system for

tracking and tracing purposes.


2. Track & Trace in the Distribution Centre

Process step 1: unloading the Transport

Physical: The pallets are unloaded in the distribution facility. If the production and distribution facility are lo-

cated in the same place, the pallets enter a finished goods store.

System: By scanning the pallets while unloading with the mobile scanning solution again two things will

happen: the automation of the goods receipt posting will be triggered in the backend system using a system

providing the necessary logic and rules framework (e.g. the edge server) and a “receiving” event will be stored

for each individual item on the pallet with a time stamp and related location in the global Track & Trace sys-

tem for tracking and tracing purposes.

Process step 2: Picking

Physical: In reference to a consignment, the ordered products are picked. It may be necessary to create entirely

new packaging hierarchies for this, e.g. if items from various outer packaging’s have to be placed together in

one new consignment.

System: In the backend system, based on the customer order, a consignment is generated and sent to the

edge server. Picking is now carried out from this consignment. If e.g. individual products are removed from

an existing packaging unit at this stage, this is registered in the global Track & Trace repository by scanning

(RFID or barcode) the units with the mobile scanning solution. The same applies if new hierarchies are for-

med. In this case, new serial numbers are also assigned. As a result, a current hierarchy is always available in

the global Track & Trace repository and it is possible to track at any time where which product is now or has

been at a given time in each packaging hierarchy.

Process step 3: generating the dispatch unit

Physical: When picking is completed, a new dispatch unit (pallet) is packed / generated.

System: The generation of the dispatch unit (pallet) is also based on the consignment received by the edge

server from the backend system. In the first stage, the picker must therefore assign the consignment from

the edge server to a mobile terminal (barcode scanner or RFID reader), which is connected to the mobile

2.

95

scanning solution. When loading the pallet, the employee scans the packages and thus aligns them with the

consignment received. If the scanned products or corresponding quantities, batches etc. do not match the

details from the assigned document, a warning notification is issued. As soon as the pallet is fully packed,

the employee closes the packing process and thereby activates the automatic generation of the pallet label

including a new serial number. As soon as all pallets in the consignment have been packed, the data is sent

from the edge server to the backend system and potential goods movements are posted. The global Track

& Trace repository holds all of the current data about the products, attributes, hierarchies and new states

(event messages, e.g. ‘packed’).

Process step 4: loading the dispatch units

Physical: The finished dispatch units are loaded onto the transport. Here, various consignments can be com-

bined in one transport.

System: For each dispatch unit loaded onto the transport, the mobile scanning solution scans the units in

relation to the shipping document. The global Track & Trace system receives the information of the scanned

units/pallets, the related shipping document and a new “shipping” event with time stamp and location, which

will be added to each individual item on the scanned units/pallets. As soon as the dispatch units have left the

distribution facility, the goods issue must be entered in the backend system. This can again automatically be

triggered with the scanning process and using business logic in a consolidation system.

Process step 5: during Transport

Physical: The transport is on the way to the next stage in the supply chain.

System: With fleet management solutions and integrated cold chain monitoring, it would be possible to in-

tegrate e.g. GPS data and temperature profiles into the global Track & Trace system. This information can

be saved at individual item level and accessed later for use by integrated alert management in such a global

Track & Trace system.


3. Sending Track & Trace Data to Authorities or supply chain partners

The following process steps are explained with an example of e-pedigree.7 E-pedigree only concerns compa-

nies in the pharmaceutical industry, however, it can (to understand the process) be adapted by all companies

obliged to operate Track & Trace due to legal provisions.

Process step 1: loading the dispatch units

Physical: The distribution facility sends the dispatch units to a wholesaler.

System: As soon as the dispatch units have left the warehouse and the goods outwards have been entered

in the backend system, an Advanced Shipping Notification (ASN) is automatically generated and sent to the

global Track & Trace system. The ASN generally contains information about the recipient, such as contact

details and address, but no serial numbers from which products would be clearly identifiable.

Process step 2: enriching the asn and sending

Physical: The manufacturer sends the wholesaler all of the information about the pallet, packaging’s and indi-

vidual products (attributes and serial numbers).

System: The global Track & Trace solution receives the ASN from the backend system and enriches it with

the corresponding serial numbers of the pallets, packaging and products it contains. The global Track & Trace

repository then converts this data into the format required by the external receiver. An external program now

receives the ASN enriched with the serial numbers, from which it generates the official E-Pedigree document.

Process step 3: receipt of the e-Pedigree document by the wholesaler

Physical: The wholesaler receives the E-Pedigree document even before the pallets physically arrive.

System: The E-Pedigree document is received by the wholesaler’s Track & Trace system, where it is checked

(sender’s authorization etc.).

3.

97

Process step 4: unloading the dispatch unit at the wholesaler’s

Physical: The dispatch unit is unloaded at the wholesaler.

System: The wholesaler enters the goods inwards in their backend system. The goods physically received are

validated for correctness against the information from the enriched ASN by the Track & Trace system.

4. Authentication

Process step 1: authentication and Track & Trace

Physical: The recipient takes delivery of the ordered products. By scanning the barcode/RFID transponder on

the product, the authenticity of the products can be checked and Track & Trace data can be shown.

System: As explained above the global Track & Trace system contains all the product-related information

(serial numbers, attributes, supply chain information etc.) right from manufacturing, through the parties in

the supply chain and till it reaches the recipient. In addition, the global Track & Trace solution can hold

authentication features, such as unique characteristics of the product. By scanning the serial number with a

mobile scanning solution, every partner in the supply chain who has access to this data is now able to view

the necessary information, in order to conclude whether the product is genuine or counterfeit. Furthermore,

all product-related data such as the date of manufacture, batch, expiry date, temperature data etc. can be

displayed for any desired point in the supply chain.

1.3 Summary of the necessary components and requirements

The simple example above, has illustrated that the following software components are

needed to fulfill the above mentioned requirements. There are additional functions avail-

able for each component, which will be described in subsequent chapters.

4.

7 An epedigree

(sometimes referred to as

e-pedigree or electronic

pedigree) is an electronic

document , which provi-

des data on the history

of a particular batch of

a drug. It satisfies the

requirement for a ‚drug

pedigree‘ while using a

convenient electronic

form (http://en.wikipedia.

org/wiki/E-Pedigree)


» Printing software/Technology

» Printing and applying the storage medium

» Etc.

Please refer to chapter V, 3.1.

» line system

» Managing local serial number ranges

» Checking Labels

» Building Hierarchies

» Etc.

This booklet will focus on Serialized Product Tracking (SPT) from Systech as a Line system.


» edge server/consolidation system

» Business Logic for automation of business processes

» Checking the physical goods against e.g. shipping documents and consignments

» Consolidation of data

» Etc.

This booklet will focus on SAP Auto-ID Infrastructure as a consolidation system/Edge Server.


» global Track & Trace system (ePcis)

» Storing all Track & Trace relevant data such as events, attributes and hierarchies

» Access/Query of all these data

» Transferring data to authorities and supply chain partners

» Etc.

This booklet will focus on SAP Object Event Repository as a global Track & Trace system/EPCIS.


99

» mobile scanning solution

» Scanning of different process steps along the supply chain to capture the data for the global Track & Trace

solution and to trigger business processes/goods postings

» Authentication features for e.g. consumers

» Etc.

This booklet will focus on Movilizer for Track & Trace as a mobile scanning solution.


» why is this booklet focused on a line system from systech?

With the friendly support from Systech, significant details and specialized knowledge has been gathered for

the chapter on line systems than what the author would have been able to provide. It is for this reason that

Systech’s solution has been addressed in this chapter.

» why is this booklet focused on the edge server and ePcis system from saP?

SAP, known as the world’s largest supplier of standard software, identified the need for Track & Trace solutions

at a very early stage and developed a software solution for this very problem over 10 years ago. All well-known

companies that have dealt with Track & Trace rely on these SAP products. No other solution is currently able

to manage the huge volume of data arising from serialization at item level and complete tracking along the

entire supply chain. The early start of development and the early confidence of leading companies that rely

on these solutions have given SAP an unsurpassable edge in terms of maturity level, stability and the standard

range of Track & Trace functions of this solution. Therefore it is justified to call them the ‘de facto’ standard.

» why is this booklet focused on the mobile enterprise application Platform from movilitas?

Besides the fact that Movilitas as a company has extensive experience in this software, it is also the only soft-

ware in the market for mobile data capturing known to the author which offers many ‘out of the box’ and

easy to implement Track & Trace features. Therefore, ‘Movilizer for Track & Trace’ is regarded as the ‘de facto’

standard for mobile data capturing in Track & Trace processes.


1.4 Short Description of necessary de facto standard components

In subsequent sections a brief description of the above mentioned software components will be covered to

provide a better understanding of the architecture overview in the next chapter.

a) Printing Technologies for Track & Trace related marking activities Tracking and Tracing applications require products and/or handling or packaging units to be uniquely iden-

tifiable. The identification if captured at the point of manufacture, is usually done automatically by a fixed

reading unit, installed within or directly after the production line.

The most common and most effective way to mark these units is to label them directly at the production line.

b) systech serialized Product Tracking - software at production linesSystech Serialized Product Tracking (SPT) application enables track and trace, ePedigree and authentication.

SPT leverages Systech Advisor and Systech Guardian to obtain Electronic Product Code (EPC) serial numbers

and assigns them to items, cases and pallets, establishing parent-child relationships for each. It also addresses

pharmaceutical manufacturers‘ needs for elegant solutions that are alternatives to customized software to

configure and administer line- and machine-level operations.

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Fig. 15: High Level Software Architecture SAP AIE


c) saP auto-id enterprise (saP aie) – edge server & ePcisSAP AIE combines SAP Auto-ID Infrastructure (SAP AII) and SAP Object Event Repository (SAP OER) in one

software package and therefore offers the possibility to use serialized information in different software ap-

plications such as for example; Supply Chain Management, production, and service- and asset management.

» saP auto-id infrastructure (saP aii) – edge server

SAP AII acts as a factory consolidation server. This means that all packaging lines are sending seria-

lized information to the SAP Auto-ID Infrastructure, which then consolidates it and sends only event

relevant information to the centralized SAP Object Event Repository. Furthermore SAP AII can be

used for the automation of logistic processes, (e.g. deliveries are confirmed in SAP AII as soon as IDs

are scanned and automatically updated in SAP ERP, including the materials movements and necessa-

ry postings). If you refer to the GS1/EPC Global terminology SAP AII is called the ‘Edge Server’.

» saP object event repository (saP oer) - ePcis

The Fig. 15 demonstrates that Track & Trace always requires a global component. A component,

which acts as a central repository for serial numbers and product related information. On the one

hand this data storage repository has to hold all product related serial numbers and information (Tra-

cking) and on the other hand it is the basis for every product related reporting (Tracing). SAP Object

Event Repository fulfills exactly these requirements and is 100% EPCIS compliant. Following the GS1/

EPC Global terminology, SAP OER is called the EPCIS-System (Electronic Product Code Information

System). In addition SAP OER takes care of the coordination of any local SAP AII system.

» saP Process integration (saP Pi)

SAP PI is an integration broker that allows the asynchronous processing of EPCIS messages. The

integration between SAP AII, SAP OER and SAP ERP is done through SAP PI. This ensures message

processing regardless of peaks within the different manufacturing locations and warehouses. With

SAP PI a Track & Trace landscape will be able to cope with incoming messages containing serialized

data. Additionally, SAP PI allows data buffering, data reprocessing and audit trail.

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d) movilizer for Track & Trace – mobile scanning solutionThe Movilizer is standard software developed and supported by Movilitas. This software is an on demand

mobile enterprise applications platform. It supports most of the available mobile devices in the market (And-

roid, iOS, Blackberry, Symbian, etc. as well as any industrial PDA/Handheld). It allows a secured connection via

end-to-end encryption with any SAP or non-SAP System. Additionally, it includes some interesting features

like usage of mobile phone cameras as barcode scanners, geo location, etc. ‘Movilizer for Track & Trace’ is

an out of the box SAP certified plug In for SAP AIE to support all Track & Trace relevant mobile process steps

online and offline.

2 Architecture examples of implemented Track & Trace software landscapes

In the following figures you will see some sample Track & Trace software landscapes that we have already

implemented at different companies.


Fig. 16: Architecture example 1 – SAP’s standard proposition

figure 16 shows SAP’s standard proposition. In short this means 1 global SAP OER, 1-n local SAP AII’s, 1-n

SAP ERP systems and integration of those via SAP PI. The line systems report serialized information and ag-

gregation information directly into SAP AII. The mobile scanning solution can be integrated in different ways,

depending on the related process step it is used for within the supply chain.

The diagrams below show different variations of SAP’s standard proposition.

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Fig. 17: Architecture example 2 – No Edge Server (SAP AII)

As can be seen in figure 17, some companies don’t use SAP AII or a consolidation system/Edge Server. Simply

speaking these are usually customers who don’t want to use the consolidation functions and features to auto-

mate logistic processes or those that only need to serialize products and store the serialized information in a

global Track & Trace repository without integration of logistic operations.


Fig. 18: Architecture example 3 – Global Edge Server (SAP AII)

It is not always necessary to use SAP AII as a local system with different instances. Generally it depends on the

data volumes and performance, specific to each company. Therefore figure 18 shows an architecture example

where only one global SAP AII system is used. These companies can still use the checks against e.g. shipping

documents at the point of scanning and automation of logistic processes but abstain from the local consoli-

dation functionalities and therefore accept a certain level of potential performance issues.

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3 Detailed description of the software components

3.1 Printing Technologies for T&T related marking activities

3.1.1 Introduction

Tracking and Tracing applications require products and/or handling- or packaging units to be uniquely iden-

tifiable. The identification, if captured at the point of manufacture, is usually done automatically by a fixed

reading unit, installed within or directly after the production line.

The most common and most effective way to mark these units is to label or mark these units directly on the

production line.

Marking Technology – regardless of its nature – impacts the production Equipment’s efficiency (OEE). OEE

impacts of up to 5% could be observed in difficult environments. Therefore, special attention needs to be paid

to the requirements for printing technology, when introduced into an operational environment as part of a

Track and Trace project.

The Basic Requirements for printing can be distinguished as General Requirements and Application specific

(Track and Trace) Requirements.

» general requirements:

» Lowest possible performance impact (OEE)

» Acceptable TCO for equipment

» Long maintenance cycles

» Required certificates for respective Production environments

» Possibility to integrate with existing Production IT Systems i.e. SCADA or MES Systems

» Printing and Application speed must to be greater (or minimum equal to) production

speed of the Line / machine


» Track and Trace Specific Requirements

» Capability of the printing equipment to reliably generate a globally unique Code (according to the desired

Standards) in the desired Code Format (i.e. Barcode, 2D Matrix Code etc.)

» Sufficient resolution for subsequent code reading applications

3.1.2 Available printing Technologies

3.1.2.1 Continuous Inkjet

The continuous inkjet technology is often used for markings onto existing wrapping materials in high-speed

applications, where a cost-effective and reliable marking technology is required. The downside however is a

degraded reading capability for automated readers compared to traditional label printing and application.

This is due to the fact that only a single line of ink is used to print the code.

In Continuous Inkjet applications, a single string of ink is adjusted up and down by piezo-electric diodes to

form – in accordance with the object’s speed.

Special kinds of Inkjet printers are the types sold by “Wolke” that use a standard Office-grade printer cartridge.

Almost the same speed is possible with this technology and the print image is more stable in terms of optical

accordance. However the printing height is limited by the Cartridges used (typically around 10mm).

advantages:

» Requires just one step to finish

» Available for very high speeds

» Relatively Robust in operation

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limitations:

» Limited printing height, which may result in small codes that are more difficult to read by automatic reading

devices

» Needs regular maintenance and supervision during operation (ink-supply)

» Material use is restricted due to possible bleeding on certain materials (e.g. dark surfaces cannot be used)

» Printing on dark backgrounds, such as corrugated cardboard, results in low contrast

3.1.2.2 Direct Laser marking

In-Line Laser marking uses an approach similar to continuous inkjet technology, however a Laser is used to

physically alter (“burn”) the base material, to add the information onto it. Laser applications are not suitable

for all applications, as it may have unwanted side-effects such as undesired heating of the content (i.e. in

pharmaceutical applications) and may increase the risk in heat sensitive environments. Also, depending on the

base-material, the actual contrast is typically lower compared to printed markings.

advantages:

» Requires just one step to finish

» Available for very high speeds

» Very Robust in operation

» No Supply materials required (e.g. Ink)

limitations:

» Printing Contrast is low -> may impose problems during reading

» Axial conformity of 2D Codes critical to achieve


3.1.2.3 In-Line Label printing and application (Thermal Transfer/Thermo Direct)

A very typical application for package markings is the in-line Label Print and application technology.

A printer with an attached application device is present on the production line and labels the goods that are

transported by a conveyor. The information is printed onto a self-adhesive label on demand and is applied

using a packaging specific application device (stamp, blow or any special combinations of these) connected

to the printer. Label printers require a certain effort in regular preventive maintenance to maintain the desired

print quality as well as to ensure proper operation and low performance impact. This maintenance usually

consists of cleaning and changing of print heads as well as maintenance of mechanical components such

as rollers, motors and transmissions. Compared to Inkjet printing or laser marking, the costs for Labels and

consumables are higher but the amount of information as well as the printing quality is best. This printing

technology is very well suited for Code-applications, such as Barcodes or 2D Codes.

For in-line label application there are two major printing technologies available. Thermal transfer and thermal

direct printing.

A) A thermal transfer printer prints onto the carrier material by melting a coating of ribbon so that it

stays glued to the material on which the information is applied.

B) A direct thermal printer produces a printed image by selectively heating coated thermo chromic

paper. The coating turns black in the areas where it is heated, producing an image.

Both printing technologies have comparable results in terms of image quality, however not all tech-

nology is suitable for all kinds of applications, as environmental factors may mandate a certain tech-

nology. If for example the product is exposed to high temperatures after the printing process, direct

thermal printing must not be used, as the thermo chromic paper may degrade (turn black) and the ID

will become unreadable.

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A) Thermo transfer Label Printing and application

advantages:

» High readability of the code

» Flexibility to include other information on the

label

» More robust labels than direct thermo printed

labels

» Lower abrasion of print heads as with Thermo

direct printers

limitations:

» Labels sensitive to temperature, light and other

environmental factors

» Relatively complex systems requiring supplies

(e.g. compressed air)

» Requires regular maintenance and constant

supervision during operation

» Considerable running costs (Labels, Ink Ribbon,

Printing heads)

B) Thermo direct Label Printing and application

advantages:

» High readability of the code

» Flexibility to include other information on the

label

» Lower complexity compared to thermo transfer

printing

limitations:

» Labels sensitive to temperature, light and other

environmental factors

» Relatively complex systems requiring supplies

(e.g. compressed air)

» Requires regular maintenance and constant

supervision during operation

» Considerable running costs (Labels, Printing

heads)


3.1.3 Conclusion

There are multiple factors that influence the choice of the best marking technology such as wrapping material,

form factor, means of transport, speed of the line, surface of packing material and others.

In general, a good compromise between printing quality, price, reliability and flexibility is available when using

Label print & applied technologies.

» in-line printing vs. pre-printed codes

In general, printing the unique code for Track and Trace purposes in-line has multiple advantages over the

usage of pre-printed codes:

Greater Flexibility

Depending on the technology used, it is easily possible to add information delivered by the printer to the

product, also in later stages.

Reliable Code-Generation

With modern printing technology it is possible that the required globally unique code used for Track and Trace,

is generated by the printer autonomously. This can guarantee uniqueness of the code by the self-checking

mechanism between the printer and a subsequent reading system that captures the code shortly after its

generation. This allows quick reaction on malfunction (e.g. duplicate printing). Furthermore, the autonomous

code generation guarantees independence of the printing system from any surrounding systems such as MES,

ERP, SCADA etc.

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Nevertheless most Printing/Print & Apply Systems can be integrated into existing environments if desired to

maintain process control and to streamline the data handling on the shop floor.

There are multiple options, to print the required T&T Code in line, the two basic concepts are via self-adhesive

label or directly onto the surface of the packaging object. It is important however, that the code is printed with

high contrast and according to the specifications e.g. axial conformity (especially important when 2D Codes

are used).

3.2 Processes, Considerations and Software at production/packaging lines

3.2.1 Quick Overview of the Systech Software Components

» sentri – machine level

Sentri offers an extensive set of vision tools including Optical Character Verification (OCV), Optical Character

Recognition (OCR), Bar Code Verification (BCV) and Print Quality Verification (PQV), which complement gene-

ral quality inspection functions such as gauging, object presence, shape, defect, count and color.

The Sentri product comes complete with audit logs to provide assurance for procedural control, quality and

regulatory compliance. It also conducts device set up, recipe-driven workflow, reject station management, and

control of intelligent online devices (printers, bar code scanners, and weight checking) to ensure integrated

quality control.


» advisor – line level

Systech Advisor is a packaging line automation product that seamlessly integrates with Systech Sentri for real-

time production monitoring, control, data collection and reporting. Advisor connects and manages intelligent

devices on the packaging line, provides data reporting and archiving, line security and procedural controls

through one central source. Advisor conducts the line management activity and data functions necessary to

support performance metrics, serialization and advanced business intelligence applications.

» guardian – Plant level

Systech Guardian enables enterprise-wide visibility of packaging line data, empowering management to make

better-informed business decisions. Systech Guardian, integrated with Systech Sentri machine vision inspec-

tion and Systech Advisor line management and control solutions, represents a comprehensive Packaging

Execution System (PES) for pharmaceutical manufacturers. Guardian is capable of supporting multiple Advisor

line solutions.

Systech Guardian also provides the foundation of unique item-level serialization and aggregation of serial

numbers to packaging units. Systech‘s software manages the writing, reading, and printing of serial numbers

at the line level and controls the provisioning of serial numbers within the packaging environment.

» serialized Product Tracking (sPT)

Systech Serialized Product Tracking (SPT) application enables track and trace, ePedigree and authentication.

SPT leverages Systech Advisor and Systech Guardian to obtain Electronic Product Code (EPC) serial numbers

and assigns them to items, cases and pallets, establishing parent-child relationships for each.

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3.2.2 Serialization walkthrough – old view, new view

For the purpose of this document the term ‘unit’ refers to the smallest packaging level

and the term ‘packaged item’ or ‘item’ refers to any package level (unit, bundle, case,

or pallet).

The traditional packaging paradigm has been to produce large numbers of identical items to an exacting stan-

dard. Thus packaging lines (manual and automated) and SOP’s for those lines have focused on making sure

every item is identical; uniqueness constitutes a deviation from the norm, which therefore makes it a reject.

These workflows do not specify the need to track the status and location of individual package items. Rework,

samples, line stops, and machine jams resulting in the manual movement of product have no impact on the

end results. It does not matter if the same bottle was inspected twice or was packed into one case, removed

and packed into a different case. Each packaged item is associated with lot or batch data; there is no need to

maintain individual data about each item. Inventory records must be created for the original lot and updated

to reflect samples, damaged goods and shipments. The focus is on quantity not tracking.

Traditional Packaging Paradigm – Produce large numbers of identical items to exacting standards.

Fig. 19: Traditional Packaging Paradigm

The serialization packaging paradigm is to produce large numbers of uniquely identified units containing

common information and associated with lot data and packed into multiple sterilized package levels. This is a

radical change in thinking at the packaging line level. Packaging workflows must now consider each packaged

item individually, track it, update its status, and reference the physical package to an individual data set. Sud-


denly operators are forced to change their way of thinking about each item. No longer can they stack cases

on the floor to keep the case packer running when the case labeler is down. No longer can they take items

from a reject bin and place them back for a re-inspection. No longer can samples be pulled from one case to

be manually replaced at the end of the lot. All of these common practices now jeopardize the data integrity

of each physical serialized item and its representative serialized data set.

serialization Packaging Paradigm – produce large numbers of uniquely identified units containing common

information and associated with lot data and packed into multiple sterilized package levels.

Fig. 20: Serialization Packaging Paradigm

It is a dangerous world outside of the packaging line for serialized items. Every step of the way, there are tradi-

tional processes aimed at breaking the integrity of the item’s data from the physical item. Sampling, reworking

damaged goods, reconfiguring pallets and manual quality inspections: all threaten the data integrity of the

serialized package.

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3.2.3 Serialization Requirements/Considerations

Serialization requires new workflows not only on the packing line but also throughout the site up until the

time of shipment. The key element in all of this is the human factor. Serialization requirements place a great

deal of burden on operators and supervisors. The automated and IT solutions, once installed, will operate as

designed over and over again. The human factor changes day by day and if not considered in the workflow, it

will result in an unstable and unreliable serialization deployment. From the operator’s point of view, the ideal

workflow would be the same for serialized and non-serialized products. The reality is that new workflows will

be required and will force changes in standard operating procedures. The key to success is to create workflows

that reduce the impact on human processes while maintaining data integrity.

Serialization starts with the provision of serialized numbers (involves obtaining unique unused serial number).

This can be a manual or automated process and can be performed ahead of time or on-demand. Once a seri-

alized number is available, it needs to be formatted in order to comply with label formats, country regulations

and data carriers. At this point, the serialized number has been issued and cannot be issued for another item.

The formatted numbers, multiple formats may have to be created from the same original number, can now be

sent to the printer or RFID reader. Once the item passes all inspections it can be commissioned.

3.2.4 How it works/How it should work

In a commissioned item, the child, is available for packing into a higher-level package, the parent. At this point

the child is considered as an orphan- a commissioned child that has not been packed into a parent. Aggre-

gation is the process of assigning (packaging) children to a parent. The aggregation rules are defined by the

packaging hierarchy, which specifies what package types can be packed into other package types (e.g. bottles

into case, case into pallet). The aggregation operation checks the child’s type, state and maintains a child count

against the required count or pack factor. If the child type does not match, or a child is not an orphan, or the

expected count is not reached, the aggregation will fail. In order to commission the parent three things must

happen:


» The parent must be issued a serialized number

» The aggregation has to be completed

» The required inspections must pass

The commissioned parent may now become a child for higher-level packages (e.g. case is the parent of a bottle

but the child of a pallet).

On line level, any serialized number assigned to an item will in general have one of three states, issued, com-

missioned or decommissioned. Decommissioning is the result of a failed inspection or a manual operation.

Once a serial number is decommissioned, its state cannot be changed. Decommissioned children cannot be

packed (aggregated) into parents.

At some point, the product will reach the highest-level package or top-level parent. The top-level parent will

vary depending on the required serialization hierarchy. For single level hierarchy the top-level parent would be

the bottle, for two levels it could be the case and for three levels it could be the pallet. Before ending the lot,

reconciliation of all the used serial numbers is required.

» dealing with abnormalities

Now that the packaging lot is over, something has to be done with the physical product and the data for this lot.

Let’s assume that we are not going to ship each pallet immediately after it is wrapped and commissioned. We

will move all pallets for the lot into a holding area until quality assurance formally releases the lot into inventory.

During this holding period, quality assurance decides they have to pull additional samples from cases of each

pallet. The removed samples will be replaced, so that all case will have a full count again. The physical aspect of

this process is straight forward but how does one allow this and maintain the integrity of the serialized data?

Manufacturers need to consider a solution that will ensure data integrity and has the ability to meet the de-

mands of existing and emerging regulations around the world (see also chapter V, 3.6 Mobile Scanning Solution).

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3.2.5 Protect data/packaging integrity and ensuring data accuracy

data integrity for serialized products is the ability to ensure that the physical world matches the data repre-

sentation. There is a large manual component to maintaining the integrity between the stored data and the

physical product. Even on automated packaging lines there exist exception use cases where product may

deviate from the expected workflow. On the packaging line quality assurance sampling, machine jams, pow-

er failures, reject bins, manual rework and quality challenges all cause multiple products to deviate from the

data representation. After packaging is complete, quality assurance sampling/inspection, damaged packages,

shipping configurations and manual rework all have an impact on the ability to maintain the match between

the data and physical world.

Maintaining Data Integrity is not just an aggregation issue but also applies to single item level serialization.

The level of reliance on the operators to maintain the data integrity is always present. It is recommended that

a solution is implemented that can reduce the dependence on trained operators as much as possible. Features

such as auto-decommissioning products that have not made it to the end of the packaging line reduce the

need for operators to manually decommission products.

virtual packaging functions support aggregations where no parent serial number is assigned. This allows a

single child serial number to be used to obtain all siblings utilizing inference to facilitate higher levels of ag-

gregation. Virtual packaging may also be used to provide some level of auto-decommissioning when dealing

with item level serialization.

end of lot reconciliation is the ability to verify that the physical world matches the data storage. A solution

is recommended that can provide reconciliation reports prior to ending the packaging lot and gives opera-

tors visibility to the commissioned, decommissioned, packed and orphaned products. This allows operators

to verify the physical product against the recorded data ensuring what was produced was not inadvertently

modified through manual intervention.


manual overrides must be in place to:

» Allow packaging to continue, if an automated piece of equipment is down

» Maintain data integrity with minimal impact on the operator

Any time an operator has to manually pack and label a case there is an increased risk of error. It is recommen-

ded to have a solution that provides checks and balances to assist the operator during the manual process

and will not allow an operation to be completed if there is a discrepancy. Additional support for authorized

exception to the rules allowing the creation of partial pack quantities when approved is also suggested.

It is important to support centralized operations such as manually palletizing to match the movement of the

physical product and the associated data. For example, when cases are completed on a packaging line and

then moved to a central area for palletizing, it is important to keep this data consistent with the case data and

all its children at the time the case is commissioned. Being able to access that data to verify that the case is

commissioned and not packed on another pallet is vitally important.

Functionality to maintain the data integrity for offline use cases is important. For both aggregation and unit

level there has to be functionality to address physical changes in the packaged product. Removing additional

samples, removing or replacing damaged packaging, replacing damaged labels or changing shipping confi-

guration all require an update of the data to match the physical world.

3.2.6 Protect packaging line efficiency and throughput

There are two fundamental principles that must be maintained for serialization to be successful in the package

environment. The first is to keep the packaging lines running. This concept goes beyond the actual packaging

line and needs to take into account the relationship with corporate networks and enterprise level systems. Having

a solution that provides a gateway between the corporate enterprise systems and the packaging line will help

(e.g. Systech Guardian or SAP Auto-ID Infrastructure or a combination of both). For serialized products this

includes provisioning, notification, number formats, packaging hierarchies and package quantities that are

required regardless of what packaging line a product is packed on.

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A solid solution will allow number ranges to be obtained from enterprise systems in sufficient quantities to

allow packing to run prior to the start of a packaging lot. A solution that provides sufficient number ranges

to run several days of any single product, breaks the dependency of IT schedules and availability for corporate

enterprise systems on packaging operations.

The second principle is to not negatively affect throughput of the packaging line. It is important that the so-

lution pre-verifies all provision number ranges and performs any pre-formatting of these numbers.

Maintaining processing data rates that exceed packaging line throughput requirements is recommended. In

this way, software is not the gating factor on line performance.

3.2.7 Serialization Considerations

» Total cost of ownership – Total cost of ownership extends for years beyond the initial equipment purchase,

non-recurring engineering and installation costs. Change control, support, training, flexibility, scalability

and lower downtime are all factors that go into total cost of ownership.

» reduced deployment risks – Serialization is a reality in today’s world. The days of small pilots for learning

are over and companies have to deal with multi-line and multi-site deployments. The deployment risks in-

clude technology, varied line equipment, network connectivity, internal engineering resources, IT resources

and corporate and site sponsorship.

» flexible – Flexibility is the ability to easily adapt to changing demands while introducing minimal impact.

Each packaging site and each line within a site has its unique set of requirements and challenges. Each site

will have preferences for specific devices and packaging equipment as well has different market regulations

that have to be followed. Packaging line workflows can range from fully automatic to fully manual and any-

where in between. Multiple lines may run the same products or individual lines may be dedicated to specific

products or markets. In the traditional packaging paradigm, flexibility was not dependent on higher-level


systems. With the serialization paradigm, data integrity must be maintained regardless of the packaging

line configuration. With the consolidation of packaging lines due to mergers and plant closures, unique

site-specific solutions will be hard to manage.

» scalable – Scalability is the ability to start with a base system and at a later date, add functionality without

replacing the base system. In today’s economy companies are merging, consolidating and cutting expenses.

To reduce their total cost of ownership they are looking for solutions that offer them an entry level that can

be scaled to meet future demands. Scalability is only truly achieved if pervious equipment and enginee-

ring costs can be leveraged. Paying twice for the same functionality is not scalable; paying for the added

functionality is.

3.2.8 Benefits of Systech’ Serialized Product Tracking (SPT)

Systech SPT’s value resides in the ability to address a manufacturer’s business concerns while supporting their

packaging needs without custom development. Since 2005, Systech has been working with customers to de-

fine packaging, use cases and uncover risk areas related to packaging serialization. This experience is rolled

into a standards library of proven work products based on actual deployments. From these standards emerge

the requirements that allow the creation of composites. Composites are packaged solution standards that not

only include the functionality, but design and validation documentation as well. Standard packages and com-

posites reduce deployment risks by reducing the design time assumptions and unknown deployment effects.

Companies can create a corporate standard deployment package that can be proven on pilot lines and then

deployed globally. Sites can benefit from previous efforts in design, configuration and validation. Repeatable

deployments are possible because all sites are based on common solution architecture. In the section that

follows there is a synopsis of some Systech specific considerations matched to the points of: Total Cost of

Ownership, Reduced Deployment Risk, Productized Solutions, Flexibility and Scalability.

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3.2.8.1 Total Cost of Ownership

Reducing the total cost of ownership by addressing the packaging serialization issue as a whole, instead of

a disconnected sub system is the ultimate objective. Unfortunately, the hidden costs and unanticipated use

cases are not obvious to manufacturers at this point. Serialization is a new concept to many companies, and

those with experience typically have a narrow perspective due to a single project executed within one depart-

ment or manufacturing site. The following is a short list of things to consider when discussing total cost of

ownership.

» Configurable Software vs. Custom Code

» Change management and the development

lifecycle

» Dealing with evolving standards

» See Flexibility and Scalability (chapter V, 3.2.7,

V, 3.2.8.4, V, 3.2.8.5)

» No standards for communication as applies

to serialization between L3-L2 and L2-L1

systems

» XML and OPC are not sufficient for real-

time processing and communications speed

(serialization) Passing data to a printer at

600 parts per minute deterministically. OPC

is not deterministic and is better suited for

batch type processes not individual items.

» Consistent architecture with a core solution

across multiple sites

» Traditional systems designed around the

ISA95 stack were focused on batch processes

and not individual items.

» Customer Support for packaging serialization

software

» What types of global support programs are

available for systems?

» Line re-validation efforts due to software up-

grades at the IT level

» Isolate changes at the plant-level from the

packaging level

» Separate packaging and IT

» isolation between packaging and IT

» Who has the ownership of bi-directional com-

munication between disparate systems?

» Ability to scale across multiple sites

» See Scalability (chapter V, 3.2.7, V, 3.2.8.5)

» Ability to gain financial and productivity benefits

from repeatable deployments

» See Reduced Deployment Risks

(chapter V, 3.2.7, V, 3.2.8.2)


3.2.8.2 Reduced Deployment Risks

As packaged software, a productized serialization solution such as Systech Serialized Product Tracking (SPT) is

ready to be quickly installed when it is bought, thereby increasing efficiency and speed of line set-up. In additi-

on to speedy installation, productized solutions are replicable, making each packaging line consistent. As more

countries globally implement serialization requirements, manufacturers benefit from investing in a serializati-

on solution that is quickly installed and replicable line-to-line or plant-to-plant. For instance, a manufacturer

who installs a productized serialization solution to address regulations in France can use the same solution at

their plant in Turkey to meet regulations there. This repeatability reduces design, deployment, maintenance,

and associated training costs. Moreover, since it does not require new code to be written, productized soft-

ware is easily upgraded and can be deployed more easily than custom software. On the other hand, custom

solutions are built line-by-line increasing the cost and time of installations. Lines of code need to be developed

for changes and maintenance, which often require more steps and more resources and results in additional

downtime for software developments. As a result, there is a greater loss of opportunity cost and additional

risks that are involved from line to line and from plant to plant.

manufacturers need to be aware of the

following:

» Additional costs that will be incurred to support

new functionality

» Systems Integrator Management costs with

regard to managing requirements, design, im-

plementation, unit testing, debugging or finally

deployment.

» Lost opportunity costs if only one vendor com-

pletes the new functionality on time

» Who is paying for the communication interfaces

that tie it all together? Is the customer paying

once/twice for each side to implement a com-

mon interface?

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3.2.8.3 Comprehensive Productized Solutions

Serialization extends risk mitigation beyond the comfort zone of most packaging engineers. Touch points that

did not exist in the traditional packaging paradigm extend beyond the packaging line and cross over to other

areas. Packaging Engineers may not be aware of the added risks or may assume that it is someone else’s

problem. IT and network groups most likely don’t realize the impact they are going to have when imposing

IT policies and requirement down to the packaging line. Corporate engineering and IT groups need to be

confident that sites can deploy quickly and with minimal disruption. Site engineers and managers need to be

confident that they can upgrade multiple lines without impacting production quotas. Site operations need to

be confident that new workflows will have minimal impact on other areas of the business.

To address corporate and site concerns it is important to combine productized software, proven standards and

a repeatable methodology to reduce deployment times and risk. By utilizing a productized software solution,

manufacturers do not have to go through the software development lifecycle for design, implementation, unit

testing, formal testing and deployment packaging. Systech takes on the responsibility of this development

lifecycle. Their development, QA and implementation procedures have been developed based upon mee-

ting the cGMP needs of their customers. They are frequently audited by their customers and maintain the

industry’s most comprehensive development and QA procedures.

3.2.8.4 Flexibility

Flexibility is the ability to easily adapt to changing demands while introducing minimal impact. Serialization

is a corporate initiative that is mandated to individual sites. Corporate has specific goals and objectives that

must be met while allowing sites the autonomy to manage site-specific requirements. Addressing the corpo-

rate needs with a common architecture but allowing sites the flexibility to manage their unique requirements

is of major importance. Refinement of workflows and device selection allow sites to achieve their objectives

while supporting the corporate goals. Sites can leverage design and validation documentation from other

sites while maintaining the ability to modify where needed.


The introduction of serialization into any existing packaging workflow will result in new workflows and proces-

ses. Some processes will have to change others will have to be eliminated or added. Software and tools that

recognize this and provide functionality to help to minimize the impact to the packaging workflows will help.

For example, if a product is run on a manual line and on an automated line only the workflow and the confi-

guration change. The solution architecture, software and deployment strategy remain the same. Systech SPT

also provides the flexibility to extend beyond the packaging line to address offline operations such as rework,

sampling and pallet building.

The following timeline shows the changes that have taken place in regards to EPC Global and GS1 standards.

In the past years the numbering format standard has changed four times. Solutions that are tightly tied to a

single number standard are not in a position to manage change without development. SPT has the flexibility

to handle evolving standards and regional regulations because the products are data carrier and number for-

mation agnostic. The formatting is in the configuration and not hardcoded in the software.

Fig. 21: Timeline of changes in regards to EPC Global and GS1 standards

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The same configuration flexibility applies to packaging hierarchies and number association. The image on

the left (Fig. 22) shows the most common packaging levels. This provides consistency across all packaging

lines and SPT work areas while allowing flexibility to handle changes through configuration. The image on the

right (Fig. 22) illustrates the flexibility to associate multiple serial numbers with a single packaged item. This

ability is managed at the Advisor SPT level and provides the support for multiple product class workflows on

the same packaging line. Similar products packaged for different geographical regions may include or exclude

data carriers. Because Systech SPT is not rigid in its numbering support data-name value pairs can be added

as needed to meet changing requirements.

Fig. 22: Configuration flexibility of packaging hierarchies and number association


3.2.8.5 Scalability

In measuring the scalability of a product family, it is not necessary to know where the start and end points are.

A product that can scale by adding 16 additional outputs may be valuable to an OEM but are not applicable

to the overall customer solution. In the context of serialization scalability needs to be assessed based on the

product’s ability to solve new application demands through the reuse of existing products. The diagram below

shows how Sentri, Advisor and Guardian scale to address different standards and regulatory requirements.

Customer’s with immediate initiatives for CIP13 can start with Sentri and then add Advisor and Guardian in

the future.

Fig. 23: Scalability of Sentri, Advisor and Guardian (pharmaceutical view)

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3.2.9 The Bottom Line

A holistic solution ends up providing lower cost of ownership, reduced deployment risks, handle site require-

ments (flexibility) and the ability to scale the solutions to meet future needs. The fewer the moving parts in-

volved, the lower the overall cost of ownership will be; this includes maintaining a high level of independence

between Packaging Operations and IT. A productized solution that is configurable instead of customizable, re-

duces the engineering cost for the contract dollars and internal resource investment. Internal resources attend

meetings that are focused on defining workflows and business use cases instead of low-level interoperability,

compatibility and software testing efforts.

Deploying a Holistic Solution will ultimately result in less time and money expended for planning, design in-

tegration and validation of disparate system interfaces. A productized solution that supports site variations

through configuration while maintaining corporate global objectives for global roll outs can leverage pervious

designs to reduce startup, deployment and validation efforts.

By leveraging the capabilities of such a solution, the overall individual site resource investment can be redu-

ced. Sites can leverage design, deployment, validation and training deliverables from other sites and adapt

them to meet their specific workflows. Sites may be less apprehensive of new technology and business requi-

rements if they all share a common approach. Greater acceptance leads to shorter deployment times by not

having to revisit every requirement and issue. If sites can see for themselves a working solution they may gain

confidence in what others have done instead of starting from a blank page each time.

Another consideration in today’s reality is the global consolidation of line equipment from various sites. If

each site has its own unique solutions, moving a packing line to another site introduces additional design and

risk into an already complex and expensive endeavor. A global solution must isolate the line variations at the

packaging level while maintaining a common IT architecture. By utilizing a common approach a line can be

moved from one location to another without requiring new integration with existing enterprise systems. The

greater the isolation between IT technology and packaging technology the easier the move will be.


A solution must be able to scale and adapt as the industry regulations evolve and internal business requi-

rements change. A productized solution allows customers to configure rather than design and implement.

Having a solution that is: evolved, maintained, tested and released following a defined and auditable product

life cycle makes things easier in many ways.

ISA 95 was created years before serialization was even a concept and was targeted for process automation

more than packaging. The reality is that PES solutions, specifically serialization solutions, do not fit perfectly

into the traditional ISA95 stack. There is a gray zone created that not only bridges the Level 3 and a Level 2

layers but plays a little in each space.

Fig. 24.: Bi-directional Data Flow

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There is no single accepted standard interface between Server Solutions (Level 3 MES) and Line Management

Solutions (Level 2 SCADA) or between Line Management Systems (Level 2 SCADA) and Line Devices (Level

1 PLC) to meet the serialization demands. Even the available standards are typically vendor specific or cus-

tomized by the systems integrator. There is no single accepted standard for high performance bidirectional

communication between these layers.

It is also an accepted conclusion that all of these elements (server, line management, devices) are required to

provide a complete serialization solution for packaging; in many cases a forth element is required to handle

offline post lot operations. These elements are now mission critical to keeping packaging running while not

impacting line throughput.

in summary you should consider the following questions:

» Who owns the lines of communication between systems?

» Who is responsible to keep up with software version and backward compatibility?

» What additional validation testing is required to exercise all of the communications between these systems?

» Can all of the above be accomplished integrating disparate systems?

» Anything can be accomplished with enough time and money but is that the best approach?


3.3 SAP AII - Consolidation software/Edge Server

SAP Auto-ID Infrastructure (SAP AII) is a flexible and adaptable infrastructure, which creates a connection

between Auto-ID technologies and existing systems. On delivery, SAP AII offers various logistical processes,

which are pre-set. Furthermore, the user has the option of adapting this content and implementing completely

individual processes in a simple way. The following diagram clarifies the main elements of SAP AII and the

integration options:

In the context of Track & Trace, SAP AII is generally used as a local solution for the issues of data consolidation,

control and automation of logistic processes.

3.3.1 Functions and Features of SAP AII

3.3.1.1 Integration Scenarios

The following integration scenarios are available for saP auto-id infrastructure:

» Standalone Installation

» Integration with the ERP system

» Integration with the SAP Object Event Repository

» Integration with the SAP Object Event Repository and the ERP system

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3.3.1.2 Master Data

The basic master data in SAP AII are products, locations and devices. A location may be e.g. a storage location.

This storage location generally has various devices (e.g. barcode and RFID scanners).

3.3.1.3 Number Range Administration

Number range administration is required in order to achieve clear identification of individual products through

serialization. The tasks of number range administration are mainly the generation, distribution and monitoring

of the individual number ranges. If several local SAP AII instances are in use, SAP OER takes on the administra-

tion of the entire global number range, whilst the local SAP AII instances order and administer the respective

local number ranges.

3.3.1.4 Rules and Activities

SAP AII offers an extensive control processor. This is where configuration takes place of what should happen

e.g. when an RFID transponder or a barcode is registered. The standard SAP AII package already includes a

large set of predefined rules and the associated activities. With the highly flexible rule framework, users with

SAP knowledge are able to adapt and add to these rules with no programming effort. New, customized rules

can, of course, be defined at any time.

135

Fig. 25: High Level Overview SAP AII


Fig. 26: Rules & Activities Framework in SAP AII

A breakdown of the main processes already supported by the corresponding rules and activities with delivery

of SAP AII out-of-the-box are listed below. Most supported processes are listed, despite not all being relevant

for Track & Trace. However, this does give the reader an idea of what SAP AII is able to support besides Track

& Trace processes.

137

3.3.1.4.1 Goods Issue

SAP AII supports the following processes in the goods outwards process, in order to be able to successfully

dispatch serialized products:

» Generation of serial numbers (e.g. EPC, DoD UII or individual formats)

» Creation of RFID transponders and/or printing of barcode labels

» Allocation of transponders and/or barcodes to packages, cartons, pallets etc.

» Automatic generation of hierarchies, e.g. with several levels for boxes outer packaging’s and pallets

» Communication of this information e.g. to SAP ERP/SAP OER

» Scanning and tracking of products or containers in relation to shipping

» Linking of serial numbers with shipping documents

» Completeness check at the point of shipping

» Automatic entry of the goods issue in the SAP ERP system

» Automatic dispatch of a delivery notice (ASN) to the customers

3.3.1.4.2 Goods Receipt

SAP AII supports the following processes in the goods receipt process, in order to be able to successfully re-

ceive serialized products:

» Receipt and processing of the delivery notice (ASN)

» Logging of the serialized information in the goods receipt control

» Reconciliation of serial numbers with the delivery notice (ASN)

» Association of serial numbers with the goods receipt documents

» Entry of the goods receipt in SAP ERP

» Automatic creation of the delivery confirmation

» Updating of SAP OER


3.3.1.4.3 Returnable Transport Items (RTI)

The RTI process involves tracking reusable items in a closed cycle (e.g. reusable containers). SAP AII supports

the following:

» Tracking the current and historic locations of RTIs on their way through the closed cycle. Here, the place

time and condition (full, empty, defective etc.) are recorded for each item.

» Creation of RFID transponders or barcode labels using all current formats such as sGTIN, GRAI, SSCC etc.

» Automatic monitoring of events and conditions and integrated notification functions (alert management)

3.3.1.4.4 Kanban

In the Kanban scenario, the serialization of containers in the production processes and the automatic initiation

of Kanban-typical replenishment strategies are supported. The following functions form the main standard

delivery package for the Kanban scenario:

» Automatic emptying of the containers and automatic set-up of the replenishment element (e.g. order, pro-

duction order, stock transfer) by scanning one or several RFID transponders or barcode labels.

» Automatic change of the container status to full and automatic stock increase in the relevant area as well

as closure of the replenishment element by scanning one or several RFID transponders or barcode labels.

139

3.3.1.4.5 Product Tracking and Authentication

The core functions of product tracking and authentication include the following:

» Recording of IDs/serial numbers, hierarchies, locations and events

» Linking of IDs/serial numbers with business objects, e.g. batches, lots, orders, consignments etc.

» Data exchange with trading partners

» Queries about IDs, status, place, events, order or other business characteristics

» Notification (alert management) in predefined exceptional situations

» Authentication using Track & Trace information (secure supply chain)

» Authentication with extended features, e.g. such as transponder ID, hologram tags, images with clear

product features

» Logging of authentication attempts and the responses

3.3.1.5 CCMS Monitoring and Alert Management

All error notifications and warnings coming from SAP AII are accessible through the standard CCMS (Computer

Centre Management System) monitoring.

3.3.1.6 Technical Reporting and Application Log

All events and movements in SAP AII are recorded in the application log. This memory constitutes the basis

for the technical reporting.


Fig. 27: Screenshot: Application Log

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3.3.1.7 Interface with SAP ERP through SAP PI

saP auto-id infrastructure can be used with an erP system to:

» Provide SAP Auto-ID Infrastructure with documents

» Provide SAP Auto-ID Infrastructure with GTIN serial number ranges

» Provide SAP Auto-ID Infrastructure with material master data

» Have SAP Auto-ID Infrastructure create and update handling unit information in SAP ERP

3.3.1.8 Other Functions

The Generic Document Interface allows the simple integration of documents into SAP AII and the processing

of these documents with Auto-ID data.

Auto-ID integration with SAP Extended Warehouse Management (SAP EWM) covers the following processes:

» Inbound, inclusive ASN handling, unloading, goods delivery (inwards) and warehousing

» Outbound, comprising picking, container processing, packing, provision, loading, goods outwards and de-

livery

» Return goods deliveries

» Resources, including the set-up of a warehouse order, opening and confirming on the basis of RFID scan-

ning procedures


3.4 SAP OER - Global Track & Trace Repository (EPCIS)

3.4.1 Classification of SAP OER in a global Track & Trace environment

SAP Object Event Repository (SAP OER) together with SAP Auto-ID Infrastructure (SAP AII) forms the SAP pro-

duct ‘SAP Solutions for Auto-ID and item serialization’ or the so-called ‘SAP Auto-ID Enterprise’.

While SAP AII can be used in manufacturing plants and distribution centers as a consolidation system for

SAP OER relevant events or for business process automation during logistics operations, SAP OER is a global

centralized system of record. It supports inter- and intra-company tracking of serialized objects and collects

and administrates all via auto-id technology (1D-, 2D Barcode, RFID, etc.) captured information in accord with

the central requirements specified by EPCglobal for an EPCIS (Electronic Product Code Information System).

SAP Object Event Repository is built on top of the very reliable and mature SAP solution called ‘Supply Chain

Event Management’. With SAP OER you will have a scalable and high performing repository for managing your

global serial numbers.

SAP OER has the mission to store all Product IDs in a global database (Tracking). Any site (Manufacturing site,

Distribution Centers, etc.) has to be able to report scanned Product IDs to the central database. For this pur-

pose, the Global Repository needs to have a standard ‘Capture Interface’ (EPCIS Compliant if interoperability

with trade partners is or maybe will be required in the future). But on the other hand, this repository is the

basis for any Product ID related reporting (Tracing). For this purpose the Global Repository for product IDs

has to have a standardized reporting interface to extract the required data. This interface is called in the EPCIS

standard ‘Query Interface’.

SAP OER is the key component of a SAP Track & Trace scenario. Due to the very large data volumes handled

in a common Track & Trace scenario, this central repository is a separated database and is not part of the ERP

System.

As you see in the picture below, SAP OER has different functions and features, which will be described in the

chapters that follow.

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Fig. 28: Main Features of SAP OER


» advantages of saP oer:

» Preconfigured out-of-the-box processes available including operational monitoring and aggregated

reporting

» Easy implementation of individual processes due to a high flexible infrastructure

» Support of established data format standards

» Active participation of SAP in all relevant standardization committees and research projects

» Continuous enhancement of supported standards according to new developments across industries

» SAP Object Event Repository is based on SAP NetWeaver Technology to provide a scalable and robust

platform

» Seamless integration into the existing SAP solution landscape

» Ensuring data security by fulfilling SAP’s security guidelines

» Proved and enhanced due to many high volume productive Track & Trace projects

3.4.2 Functions and Features of SAP OER

3.4.2.1 The EPCIS compliant Capture Interface

This Interface allows your Manufacturing Plants and

Distribution Centers to send Product ID informati-

on to SAP OER in a standardized format (In form of

EPCIS Events).

In the standard EPCIS specification, there are typi-

cally four different Event Types:

» Object Event

» Aggregation Event

» Transaction Event

» Quantity Event

145

SAP OER supports all four event-types. For more information about event formats, parameters etc. please refer

to the GS1/EPC Global EPCIS standard specification.

SAP OER is 100% EPCIS compliant, which means that the capture interface as well as the query interface

(which is described later) is delivered as a part of the standard software. Both interfaces are accessible in the

development workbench via the transaction ‘sproxy’ (Transaction displayed in the screenshot below). The

capture interface and its processing and monitoring capabilities in particular are crucial strengths of the SAP

OER solution.

Fig. 29: Transaction SPROXY

Beside the above mentioned event types the capture interface supports, via EPCIS vocabularies, any kind of

‘bizSteps’, which can be defined via configuration (e.g. commissioning, decommissioning, shipping, dispensed,

returns, recalled).

The capture interface during the processing logic is able to execute any rules defined within the rules framework.


Therefore, it is possible to trigger any consequent action as a result of an event processing. An example here

would be to change the status of a given ID (e.g. to ‘shipped’) according to the ‘bizStep’ (e.g. ‘shipping’) con-

tained within the incoming event.

Aggregation events are supported and so SAP OER is capable of creating (packing with Action = ADD) or

delete (unpacking with Action = DELETE) a hierarchy of IDs at any point of time. Multilevel hierarchies are

supported as well (e.g. an item-case-pallet is a three level hierarchy).

The capture interface supports EPCIS messages of large size containing multiple EPCIS events. It is however

recommended, for performance optimization reasons, that the sending applications limit the size of the EPCIS

messages. However, the capture interface supports parallel processing of multiple messages.

Additionally, it is possible to implement any customer specific logic in the capture interface via BADI imple-

mentation (customer enhancement rather than implementation). This allows for example; to easily implement

any authorization check before event processing (e.g., check if incoming request belongs to authenticated

users with registered addresses IP/MAC Address). It also allows checking of commissioned IDs for a registered

company prefix from the sender (in case the target country uses GS1 GTIN standard).

Non real time processing of EPCIS message is supported in SAP OER as well.

saP oer handles two timestamps as standard:

» Event Timestamp (recorded by the actor and part of the EPCIS message)

» Record timestamp (recorded by SAP OER and documenting the arrival of the EPCIS event in SAP OER)

147

Fig. 30: View of the Integration Engine (Part of SAP PI stack integrated in SAP OER)

The relevant timestamp for processing steps is always the event timestamp.

SAP OER also offers a track changes functionality for any status change. Timestamp, user, old value and new

value can be logged for any ID status change. However, in large volume scenarios it should be considered that

switching on the track changes functionality generates a considerable amount of additional data that needs

to be handled additionally.


3.4.2.2 The EPCIS compliant Query Interface

This interface allows internal and external users (e.g.

legal authorities) to report on the Product ID infor-

mation in a standardized format (In the form of EP-

CIS queries).

Thanks to this interface, any business user is able

to retrieve data based on any parameter out of SAP

OER (e.g. product IDs in a given timeframe reported

by a given business location).

In EPCIS specification, there is one generic query,

which is called ‘Simple Event Query’. With this event

query it will be possible to retrieve the data corres-

ponding to the EPCIS events specified by the para-

meters in the query. Additionally this query can be consumed by ‘Interrogation’ or by ‘Transmission’, for which

SAP OER as well as the EPCIS Specification has defined the concept of ‘Subscriptions’. For more information

about the Query Interface please refer to the GS1/EPC Global EPCIS standard specification.

» additional reporting functionalities (standard saP oer)

Additionally, SAP OER provides a standard reporting interface (not EPCIS compliant), which is available via the

web. In general it is possible to authenticate the user based on user and password in order to allow a report

to be run.

The report interface in SAP OER supports role based assignment of reports. Each web report in SAP OER ter-

minology is called ‘Web Interface Transaction’, and can be highly configured.

Modifying exiting reports or creating new reports based on existing reports can be done mainly via customi-

zing (no programming required to hide or display fields). BADI’s can also be populated to fill certain report

fields if required with specific logic etc.

149

Fig. 31: SPRO transaction to configure fields for display and selection.

Fig. 32: Sample of standard web report (Web Transaction)


3.4.2.3 The Event Handlers, Event Messages and Hierarchies

In SAP OER, Event Handlers are “IDs”. This means

that any ID/serial number that needs to be tracked

(e.g. Item IDs, Cases IDs, Pallets IDs or even Delivery

Document IDs) becomes an Event Handler in SAP

OER. Event Handlers can then have:

» A current ID hierarchy (e.g. Pallets have cases and

cases have product items)

» One or more event messages

The reason why IDs are called Event Handlers in SAP OER terminology is that Event Handlers are able to hand-

le events (in our particular case EPCIS events like Object Events, Aggregation Events and Transaction Events).

For example a pallet ID could have one or more event messages such as ‘Packed’, ‘Shipped’, ‘Received’, etc.

This means that in SAP OER, each single Product ID becomes an Event Handler. But this also means that any

Document ID becomes an Event Handler in SAP OER as well. (E.g. every Outbound Delivery, Inbound Delivery,

Stock Transfer Order etc. becomes an Event Handler of a different type)

Event Handlers are the most important entities created in SAP OER and can handle Rule Sets, expected or

unexpected event messages, Status Profiles and Additional Parameters.

151

Fig. 33: Event Handler

It is possible for example, to define different types of Event Handlers in the system, having different attributes,

different status and different associated behaviors.


Fig. 34: Standard Event Handler in SAP OER - Header data

Although the standard Event Handler entities allow lots of configuration and parameterization in SAP OER (as

depicted in the picture above) the leanest possible implementation of the Event Handler entity is recommen-

ded considering the expected volumes of data.

Event Handlers in standard SAP OER can receive one or more EPCIS events (Event Messages). The description

of the Event messages is taken from the bizStep. BizSteps are customer vocabularies and can be configured

specifically via standard SAP Customizing

153

Fig. 35: One Event Handler can handle multiple events

Additionally, Event Handlers are able to have one or more hierarchies in SAP OER standard at different points

of time. Hierarchies are always updated in SAP OER by the EPCIS Aggregation Events (representing packing

or unpacking).


Fig. 36: One Event Handler handling multiple hierarchies at different points in time

For example, in SAP OER it is possible to display the hierarchy contents of a pallet.

but there are two different types of hierarchies:

» Current Hierarchy

» Hierarchy valid for a given event (Event Hierarchy)

For example, a given Case ID may have been packed in totally different pallets after the packaging in the ma-

nufacturing plant and after the shipping from the Distribution Centre. SAP OER supports the management of

these different hierarchies during the Product ID lifecycle.

155

» event handlers attributes

In SAP OER it is possible to define and populate via the capture interface any specific attributes that may be

required for the Product ID without any code of programming (via configuration). Some typical attributes are

for example Product ID, Batch Number, Expiration Date, Unit of Measure, etc.

3.4.2.4 SAP OER: Tracking Services and Rule Processing

Whenever an event message arrives in SAP OER, the

rule processing starts the execution logic. For each

of the Event Handler types contained in an EPCIS

Message SAP OER can execute different rules. It is

here that custom logic can be added during mes-

sage processing. For this purpose SAP OER offers a

very flexible configuration workbench which allows

consultants and IT staff with ABAP knowledge to

create rules, conditions etc. without programming

efforts. The rules engine is already a standard com-

ponent in SAP OER. The Rules Engine allows adding,

deleting or modifying any rules via the SPRO transaction in the SAP customizing workbench. SAP OER pre-

delivers rules for all relevant EPCIS events. Predefined rules for Object Events, Aggregation Events, Transaction

Events and Verification Events also exist. Additionally via SPRO it is possible to define new rules via a system

assistant (Not exactly a rules wizard, but a kind of graphical tool delivered in SAP OER standard). Adding new

rules to the rule engine does not require any system downtime, and any of the rules built within the framework

is able to access any of the inbound parameters passed through by the interface (including potentially newly

defined parameters). Rules can be defined at a very low granularity and within the rules processing frame-


work it is possible to call any type of remote function, which is able to trigger the connection to any external

system. Of course the rules engine supports parallel processing and asynchronous communication, so that no

messages can be lost unprocessed (messages are stored in the SAP OER integration engine before and after

processing with the current status).

Fig. 37: Graphical tool (“wizard”) for rule definition in the SAP OER configuration workbench (Transaction SPRO)

157

3.4.2.5 ID Types

In SAP AII (in the stack of SAP Auto-ID Enterprise),

ID types are used to specify the formats of the IDs

passed to SAP OER via the EPCIS message. This is

only relevant to guarantee interoperability with tra-

ding partners in the future.

3.4.2.6 Authentication

SAP OER supports technical authentication fea-

tures. This authentication means that via a Web

User Interface, an OER user is able to ‘authenticate’

a given Product ID based on the ID and based on

additional attributes if required (any authentication

feature can be defined in SAP OER).


3.4.2.7 Alert Framework

It is possible to use this feature as an alert system to

notify the SAP OER system administrator about any

irregularities or potential bottlenecks, inconsisten-

cies etc. in the Track & Trace scenario.

E.g. an ID was marked as ‘destroyed’ but then, in a

later stage the same ID was scanned during a ship-

ping process; this could trigger an alert.

For this purpose SAP OER offers integration with the

standard SAP monitoring system so called “CCMS”

(Computer Center Management System).

SAP OER offers a full-blown alert framework, which

allows any agent to be notified about any irregulari-

ties or potential bottlenecks, inconsistencies etc. in

the Track & Trace system.

159

Fig. 38: Multichannel alerting

Via configuration in the alert framework it possible to define:

A) When an alert is triggered (embedded within the SAP OER rules engine)

B) What should happen: the ABAP program to be executed can be defined via configuration

C) To whom it should be sent: alert recipient can be determined

D) What should be sent: text and content of the alert

E) How it should be sent: via email, fax, text message etc.

For this purpose there is a specific customizing node in the transaction SPRO where any alerts can be configu-

red and custom built with minimum or no development. Generated and notified alerts are always registered

in the SAP OER system for audit trail purposes and can be accessed via the standard transactions ALRTDISP

and ALRTINBOX.


3.4.2.8 Central number range management

SAP OER is able to control the creation and distribu-

tion of number ranges in a system landscape with

one or more instances of SAP AII. SAP OER has a

number range administration user interface: it of-

fers an upload report for integration of external

number ranges, Web Services to allow the request

of additional serial numbers (e.g. for Third Party

Manufacturers integration), is able to block and al-

locate number ranges and keeps a historical log of

distributed number ranges etc.

161

Fig. 39: Central Number Range Management

However, the standard SAP OER functionality for number range management does not support randomized

numbers. In order to support randomized numbers an external tool/algorithm for serial number randomiza-

tion has to be used (see chapter V, 3.4.2.9). This tool will receive an index from SAP OER, based on the index,

parameter and the number of ID’s to be generated, it will generate a block of randomized serial numbers. The

generated block is then uploaded to SAP OER.

3.4.2.9 Excursion: Serialization vs. Randomization

Serialization is the technique to mark items or objects with a unique numeric or alphanumeric identifier. This

technique is applied wherever unique identification of single objects is required. Examples include the ship-

ment tracking provided by parcel services, the tracking of components in the assembly of e.g. cars or electro-

nic devices, and the registration of end-consumer products on a manufacturer website as part of the warranty

processing. What these examples have in common: The information related to a single object unveils its value

in particular if one can get access to the physical object too.


However, a second type of situations exists where just the knowledge of a serial number provides a benefit.

Activating the copy of software through the internet using the software license code or earning bonus points

in a customer loyalty program by entering promotional codes on a website, are examples, where, whether the

requester has the actual object or not cannot be controlled or verified. To avoid any misuse, it is of utmost

importance that the serial number cannot be guessed or predicted, not even with the knowledge of other valid

serial numbers. The method of choice for this second scenario is: randomization i.e. usage of random numbers

as serials.

Unfortunately, standard random number generators lack the uniqueness of the generated serials. This leads

to a trial-and-error type of implementation that is similar to dicing: A number is generated and checked for

previous occurrence. If the number is already known it is thrown away. If not, it is accepted. A major disadvan-

tage of this type of method is the time required to calculate the next serial and thus, the effort to exploit the

full pre-defined number range grows exponentially.

Fig. 40: Effort for dicing-type

methods in relation to number

range exploitation

163

As we have seen, generating randomized serials using a random number generator is not the best option for

a Track & Trace scenario. A ‘direct formula’ that has a sequential index as an input and calculates the random

numbers out of this index is much more suitable. But how can it be assured that the calculated numbers are re-

ally random? The European Federation of Pharmaceutical Industries and Associations (EFPIA), has formulated

minimum requirements on the quality of randomization for their case of application. They postulate that the

probability to guess a valid serial number should be less than 1:10.000, that the serials are independent and

distributed across the entire number range, and that they must not be built using an algorithm that is easy to

decipher when a given set of serials is known or a subset thereof.

To summarize, the requirements for randomized serialization are as follows:

» The serial numbers must be unique

» A prescribed number range should be fully exhausted

» The randomization should fulfill appropriate quality criteria

» The generation of serials should be with high performance

An algorithm that fulfills these criteria is the BayCoder® that has been developed by Bayer Technology Servi-

ces GmbH. This algorithm is in use in different industries and comes with additional features that are impor-

tant for its customers. First of all, the customer itself parameterizes it, so that no third party is able to generate

identical serial numbers. Furthermore, it calculates each serial in less than 1 msec i.e. the production output

is not negatively impacted. Due to the lean implementation, no additional hardware is required. And finally,

it has proven to be quick and easy to integrate into existing serialization solutions (e.g. SAP OER) due to its

standardized interface.


3.4.2.10 Master Data Management

In SAP OER it is usually possible to replicate the fol-

lowing master data (not mandatory) from the SAP

ERP system:

» MATERIALS (Material IDs and Description, Unit of

Measure and Conversions, EAN numbers, Number

Ranges (only required for repacking purposes)

» In addition to the materials, in SAP OER the fol-

lowing master data is defined (this can also be

defined in SAP OER directly):

» locaTions (Location IDs, GLNs, Location ID

Mapping Readers etc.) Location ID Mapping

Readers are optional. Only if detailed informa-

tion is required

» oTher Master Data required for delivery Infor-

mation (e.g. Sold-to-party, Ship-to-party), &

Business Description of Events (EPCIS bizSteps)

165

3.4.2.11 Locations & reading points

In SAP AII (in the stack of SAP Auto-ID Enterprise)

it is possible to maintain Locations and Reading

Points. Locations are the sites reporting Product ID

information to SAP OER (E.g. Manufacturing Plants).

Reading Points are areas within those locations.

(E.g. Packaging Line 1 at the Manufacturing Plant)


3.4.2.12 Archiving

SAP OER contains archiving tools to save SAP Event data on external mediums and then deletes data from the

database.

The following objects can be archived in the object event repository:

» Event Handler Tables (e.g. All item, cases and pallet IDs)

» Event Messages Tables (e.g. All event messages to item, cases and pallet IDs)

The approach is based on the assumption that for each object/Event Handler an event can be defined that is

the last event expected to occur for the said object. When tracking an item from production to goods issue

for instance, the last event to be monitored is the goods issue event. This goods issue event can be identified

by a number of parameters, e.g. event type, business step, action and location. When this last event happens,

the representation of the object and the relating events shall still be retained in the database for a pre-defined

“residence time”. Within this residence period all selection criteria supported by the database can be used and

(if configured accordingly) further events, which were not expected to happen can still be received. As soon

as the residence time has passed, the object will be archived. If those event messages need to be displayed

completely, the standard SAP OER user interface (Web UI) is able to display archived and non-archived data

within the same screen.

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3.4.2.13 EPCIS Vocabularies

EPCIS Vocabularies are nothing other than the

descriptions of the EPCIS Events (e.g. Shipping,

Packing, Receiving, Decommissioning, etc.)


3.5 SAP Process Integration (SAP PI)

SAP Process Integration (SAP PI) is the interface from which the SAP OER system can be reached. Any inbound

and outbound message will always go through SAP PI.

The main functions of saP Pi are:

a) monitoring: It allows the monitoring of the inbound and outbound queues, provides the ability of displaying the EPCIS

Message processing status and also offers reprocessing capabilities (in case of EPCIS message failure).

b) buffering: Any EPCIS message is buffered in the SAP PI integration engine. The size of the buffer is configurable, but

typical customer implementation allows a 4-week buffering period, so that any incoming or outgoing EPCIS

message is accessible via the integration engine. This provides audit trail functionality for a 4-week timeframe

in which the buffering occurs.

c) routing: The SAP PI integration engine allows message routing in both directions (in and outgoing messages). Ad-

ditionally SAP OER has an integration engine (accessible via the transaction SXMB_MONI), which effectively

allows SAP PI message monitoring directly in SAP OER.

3.6 Mobile Scanning Solution

Mobile scanning is the only way to guarantee that product IDs are scanned as they move across the supply

chain. Therefore a Track & Trace solution will sooner or later require mobile access to at least the global repo-

sitory. Access will primarily be required for: verification purposes, special exceptional situations (e.g. decom-

missioning IDs) and operations with aggregations for example (e.g. packing, unpacking, shipping, rework).

169

3.6.1 Movilizer for Track & Trace – Architecture

Fig. 41: Movilizer for Track & Trace - Architecture


5. The movilizer client is a very small software (some few Kilobytes) written in different native languages

(depending on the target device) capable of running on most mobile phones, smart phones, PDA’s, Tablet

PC’s, industrial devices, etc.

6. The movilizer cloud is a secured multitenant and hosted middleware with 99,5% guaranteed availability

that can connect any backend system with any mobile device by sending and receiving business data in

both directions. Because it is multitenant, it allows economies of scale (single infrastructure is leveraged by

many tenants). The Movilizer cloud follows the classic principles of Software as a Service (SaaS).

7. The movilizer connector is a SAP certified “out of the box” Connector available for SAP OER, SAP EM and

SAP PI, which once installed on the system, accelerates the integration of the system with the Movilizer

Cloud and provides all features described in the following chapters.

3.6.2 Technical Features of Movilizer for Track & Trace

» Online & Offline capability

» Optimized for sites with poor infrastructure (maximum data compression)

» 100% EPCIS compliant

» Background integration with existing DSD, PoD mobile applications

» Background integration with exiting mobile Warehouse Management applications

» Barcode/RFID Scanning

» Supports Printing (for Re-Packing and other reports)

» Offline field validations of any type and centrally managed

» Capturing of GPS geo-coordinates

1.

2.

3.

171

3.6.3 Supported Processes

Movilizer for Track & Trace supports all Track & Trace relevant processes, which are required by a mobile scan-

ning solution for supporting Track & Trace at a glance. In the picture below you can see an overview of the

supported processes. In this section the key processes will be described in more detail.

Fig. 42: Overview supported Processes


3.6.3.1 Capturing packing events

In order to be able to pack, the parent ID is normally entered followed by all the children IDs that are packed

into the parent. With this function it is possible to pack any hierarchy level (e.g. packing items into cases,

packing cases on pallets). In SAP OER the packing events and the corresponding Hierarchy can be seen.

Fig. 43: Sample Hierarchy in SAP OER

3.6.3.2 Capturing unpacking events

In order to be able to unpack, the parent ID is normally entered followed by all the children IDs that are being

unpacked. With this function it is possible to unpack any hierarchy level (e.g. unpacking items from cases, or

unpacking cases from pallets). The changed hierarchy is then automatically updated in SAP OER.

173

3.6.3.3 Capturing shipping/receiving events

In order to be able to capture a shipping or receiving event, normally, the reference document number must

be entered or selected, against which the shipping (outbound delivery ID) or receiving (inbound delivery ID) is

being done. Once the Delivery ID is entered, the user can then proceed to enter the Pallet IDs (or cases, items

IDs) shipped or received with the delivery.

As soon as the delivery is completely shipped, the synchronization is started and SAP OER will be updated.

Alternatively it is possible to get a confirmation screen with the details of the shipped Ids. In SAP OER the

Product IDs (including Pallets and cases can be displayed) as well as the details of the corresponding delivery.

3.6.3.4 Decommission – Capturing decommissioning events

In order to be able to document the destruction of Product IDs, the user would use decommissioning function.

Via this function, it is possible to decommission a single ID (provided the hierarchy was unpacked before) or

the entire hierarchy (e.g. a full case with its corresponding items can be fully decommissioned). In SAP OER the

new event „decommissioning“ will be visible not only for the observed ID (e.g. the case ID in case a full case

was decommissioned), but also for all Product IDs contained in the hierarchy.

3.6.3.5 Verify/Authenticate Product ID’s

This feature allows any Product ID to be verified against the global repository. For this, the user enters the

Product ID to be verified and the synchronization starts automatically. SAP OER then sends the relevant infor-

mation with regards to the Product ID (Event handler attributes and overall status „known“ or „unknown“) to

the mobile device. For each verification transaction, an event type ‘authenticated’ is created and booked in the

system containing the requestor of the verification event as well as the timestamp for when the verification

event was created. Thanks to this feature audit trail is guaranteed.


3.6.3.6 Design and print Track & Trace labels

For re-labeling or re-packaging processes it is important to take label-printing options into consideration.

Therefore the ‘Movilizer for Track & Trace’ offers label-printing functionalities out of the Movilizer Cloud (using

third party NiceLabel software).

» Enables any label to be printed out of the Cloud without requiring any additional new infrastructure in the

IT landscape

» Requires no footprint to be deployed locally other than a local printer connected to any standard PC with

periodic connection to the internet

» For the purposes of business continuity, there is offline functionality within the Printing portal. The purpose

of this functionality is to enable users to continue printing in the event of losing network connectivity

» Over 2000 printer types supported, with out of the box drivers

» Flexible label and forms designer allows printing layouts to be easily defined centrally

3.6.3.7 Device management

Dispersing several devices around the world, often in areas with no IT experts in place, results in the need for

central control of the devices. Therefore, a Device Management tool will be necessary.

a mobile device management tool is mainly

required for:

» Remote control for helpdesk (troubleshooting)

» Preventive control of hardware resources (sto-

rage capacity, timestamps etc.)

» Security: killing the device in the event of losing

etc.

The major features provided in that area are:

» Remote Device Control

» Lock Device

» Wipe Device

» Send Message

» Warm/Cold reset

» GPS Tracking

» Screen Capture

» Device Status

» System Manager

» Call Log

175

3.6.3.8 Create Marketing/Change Management and Communication mobile Apps for e.g. Smartphones

The Movilizer can improve change management and communications by providing the following features:

a) dynamic contents which are always available (offline support):

Today, commonly used platforms for change and

communications management are still Power Point,

PDF files, flyers and some more advanced portal

based solutions. Most of them have the disadvan-

tage of being static, so the contents and key mes-

sages cannot be changed without considerable ef-

fort. Via a mobile App, organizations will be able to

update the contents without programming efforts

and without end user involvement (changing the

content of the app does not require any new de-

ployment of the App).

b) role based approach:

The contents of the App can be defined at very low

granularity, so that it is possible to define user roles,

which have a different view and access to different

functionality within the application. Roles and users

can be managed centrally out of the Movilizer

cloud. (E.g. country manager sees T&T project de-

tails like timelines, but an operator is not able to see

them). Furthermore an App can increase the level

of engagement and involvement from the stake-

holders involved compared to a document.

c) mashing up Track & Trace communication with Track & Trace functionality:

It is possible to embed communications and

change management within the application itself.

E.g. ‘white-collar’ users of the mobile App could

run ID authentication out of the App and ‘blue-

collar’ users of the App could see an additional

menu item on their handheld, where they are able

to find user manuals and FAQs.

d) Two way communication channel:

With using a mobile App for communications and

change management the communications mana-

ger can also receive end user feedback in the form

of surveys or questionnaires, which can be embed-

ded within the App contents. It is possible to defi-

ne the structure and contents of the questionnaires

without any programming skills and the answered

questionnaires will be available in digital format

automatically.

e) usage statistics and usage patterns:

Via the app it is possible to monitor the usage of

the mobile application and recognize behavior pat-

terns etc. User synchronization and navigation can

be protocolled and in this way centrally monitored.


Fig. 44: Sample screenshots of a Marketing/Change Management and communications app


Fig. 45: Sample screenshots of a Marketing/Change Management and communications app


3.6.4 Security of Movilizer

Security is always a major problem in Track & Trace projects. In particular in a scenario where another user/

system is accessing the global database where serialized information is stored. Therefore, security is a very

important topic for the mobile application platform.

The security of the Movilizer has already been proofed and accepted by several customer audits and because

the Movilizer is a cloud based mobile application platform its security standards will be discussed as a kind

of benchmark of security features which have to be fulfilled by a mobile enterprise application platform, in

particular when considering cloud based solutions.

3.6.4.1 Security of the Cloud Servers

The servers are hosted in a secure computing center on a multi-tenant server landscape, which obeys the

following standards:

security » Building safeguarded through a VdS certified gu-

ard service

» 24x7 responsible Security Manager according to

BDSG

» Electronic access control for respective security

levels

» VdS certified alarm system

» Closed circuit surveillance for both interior and

exterior areas

fire protection » VdS certified fire protection

» VESDA early warning system

» VdS certified extinction system

» Supplementary measures for fire extinction ac-

cording to BGR 133

» Fire safety engineer according to VFDB 12-09/01-

2009-03

» Architectural measures with T30-RS doors, and

F90 walls according to DIN 4102

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3.6.4.2 Data Management

Enterprise information will be stored inside the Movilizer Cloud only while it is required to execute the corre-

sponding business processes on a mobile device. The Movilizer does not represent, and cannot be compared

with, a database for storing company data in terms of database outsourcing.

Process related information is kept on the Movilizer server as long as the corresponding process step is still

located on a mobile device. Reply information for a process will be stored on the Movilizer server until it has

been transmitted to the source system, e.g. SAP OER (acknowledgement mechanism). Additionally, data will

be stored for monitoring purposes for a defined period of time.

The process related information is stored in the Movilizer database in an unstructured format (text represen-

tation). The business data is filed together with formatting information and technical characteristics, which

complicates an automated analysis. In addition, only fragments of information will typically be part of a mobile

process therefore, no complete business information units (business object instances) will be transferred to the

Movilizer Server as a whole.

failover concept » 24/7 staff availability in the datacenter

» Power Grid Ring Structure, n+1 Emergency Pow-

er Concept, n+1 redundancy for Air Conditioning

Systems, Network and Power Grid Uplinks

» 3 Emergency Power Aggregates (5.540 KVA and

51.000 liter oil reserve)

» Redundant entrances for suppliers

Certifications » Certified high availability and security: Level Tier

3 (TÜV Saarland)

» Certified high availability and security standards

according to ISO 27001

» Eco Datacenter Star Audit Level 4


3.6.4.3 Data Transfer

Data transfer among the system components will be executed securely, by applying high grade SSL encryption

The following communication paths exist:

» Source system customer - Movilizer Cloud

» Movilizer client - Movilizer Cloud

Data transmission between the backend system (e.g. SAP OER) and the Movilizer Server will happen via a SSL

encrypted http connection. The connection can additionally be routed via a regular web proxy.

The authentication information for the Movilizer web service is part of the payload data. It will therefore also

be subject to SSL encryption.

Fig. 46: Source system customer - Movilizer Cloud

The initiator of data exchange is always the customer system (e.g. SAP OER). Therefore a customer network is

not required to accept incoming calls. For the encryption, a Thawte SSL certificate is used.

The data exchange between a mobile device and the Movilizer Cloud is also accomplished via an SSL- secured

http connection (https). For encryption a Thawte SSL Certificate is used.

183

Fig. 47: Movilizer client - Movilizer Cloud

3.6.4.4 User authentication on a mobile device

In the standard deployment, the mobile client becomes personalized during installation, and does not need

any further user authentication at start-up.

If required, user authentication can be activated. In such a case the user must enter a password phrase before

the Movilizer can be used. Some users also prefer authentication cards for user authentication.

The password for this purpose will be transmitted to the mobile device in the form of a MD5 hash code. The

input of the user will be translated into a hash value as well. If both hash code values are identical, access to

the functions of the Movilizer client is granted.

The password of the mobile user is not saved on the mobile device, neither in plain text nor encrypted. The

password cannot be reconstructed out of the hash value either (one way transformation).


3.6.5 Sample Screenshots of the mobile Application

Typically these transactions run on industrial mobile devices such as Intermec or Motorola barcode scanners.

However, it is also possible to use the same transactions on smartphones.

185

Fig. 48: Sample Screenshots of the mobile application for Track & Trace

186 Best Practices - How to start a global Track & Trace project

Best Practices - How to start a global Track & Trace project

vi

187

1 Disconnection of serialization and Track & Trace

To ensure that products are serialized and traced in a consistent manner, many companies develop separate

user requirements for both serialization and for centralized business systems (e.g. SAP OER) used for Track

& Trace. (In this chapter serialization mean all activities, which have to take place to get the production lines

ready to serialize products)

Serialization requirements provide in general, guidance for how products will be encoded at packaging sites,

while the Track & Trace requirements focus on the systems that will manage information about serialized

items. Separating requirements for serialization from Track & Trace allows local packaging sites to implement

serialization technologies that meet their regional requirements the most, while allowing centralized traceabi-

lity systems to be defined by a central IT department and supply chain responsible persons.

a serialization requirements document covers in general (high level only):

» Serial number and data carrier formats

» Handling of pre-encoded serial numbers

» Recording of serial numbers

» Communication of packaging batch serialization

information to Track & Trace systems

» Software used at a packaging site to store serial

numbers before transmission to a central Track

& Trace system

» Serial number allocation

» Packaging control and inspection software

» Hardware used for encoding or reading seria-

lized items

» Etc.


Fig. 49: Serial Number Lifecycle

2 Business Blueprint of a global Track & Trace System

In the previous chapter we learned why some companies disconnect serialization and Track & Trace systems

from a requirements and project setup point of view. As Movilitas is an expert in setting up Track & Trace

systems, the focus in the following chapters will be on the work packages that are necessary for setting up a

global Track & Trace system and the necessary documentations to start implementing such a system.

189

2.1 Business Blueprint & Functional Specifications & Technical Mapping

as already mentioned, Track & Trace Projects are, from experience, always global projects. There are

various reasons and could be as follows:

» For example it makes no sense to have more than one global EPCIS System to manage and store the serial

numbers of a company. This means that all plants, factories, warehouses, etc. have to report the serialized

data and supply chain information to this single global repository.

» Also the underlying software components such as EDGE Servers are affected by the way data is received

and managed.

» Considering the synergies of all line systems and printing technologies on a global level can be an inte-

resting prospect. The reason is that in most cases many of the production and packaging lines are not yet

equipped with the necessary technology to serialize products during the production and packaging process.

Due to the typically global nature of Track & Trace projects; stakeholders from various countries, business are-

as and divisions are inevitably involved (IT, Logistics, Supply Chain, Plant Managers, Packaging, Commercials,

Marketing, Managers). Therefore, it is crucial to commence Track & Trace projects with a detailed Business

Blueprint and writing of Functional Specification. If this is not done, it can lead to expensive change manage-

ment activities in later stages.

The following are typical topics, which should be touched on during the blueprint phase of setting up the

software systems and processes. Some of them require more attention than others, but these are the key

considerations.


2.1.1 Business Blueprint & Functional Specifications

During Business Blueprint workshops the following topics should be covered in order to create a comprehen-

sive business blueprint and appropriate functional specification documents:

» business Process summary: Summarizing the overall business processes, which will be affected due to the

implementation of Track & Trace on a high level.

» serial number management: This topic is about where the serial numbers are generated, where are they

managed, which formats will they have, are there national codes which have to be included, is the govern-

ment or authority providing serial numbers, are randomized serial numbers required, are there external

serial numbers which have to be transferred into the global repository, should the number ranges be given

to 3rd party manufacturers, etc.

» managing labels: This topic relates to the serialization at packaging lines

» manufacturing Processes: Capturing in detail on a global level all manufacturing processes and what hap-

pens at each stage with the serial numbers, e.g. when should there be an interaction between line systems

and EDGE/EPCIS System, etc.

» site logistics & warehouse processes: Capture all Track & Trace relevant logistic and warehouse proces-

ses, how to collate Track & Trace relevant data in the different steps in the software systems and what should

be done with it, are there any processes or postings that should be triggered automatically, etc.

» special scenarios in supply chain: Are there any special scenarios?

Maybe only relevant in dedicated countries?

» exception processes within supply chain: Are there any exceptions from standard processes?

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» integration of supply chain stakeholders in the Track & Trace repository: Who has to interact with the

global EPCIS System, what are the interaction patterns, how are they integrated, etc.

» main features: What are the main features of the Track & Trace systems, e.g. product verification, exception

handling, product history, product re-packing, entering of new product details, product recalls, administra-

tive features, etc.

2.1.2 Technical mapping of the requirements

while mapping the requirements gathered during business blueprint workshops, for the technical fea-

tures more in-depth topics must be considered, such as:

» Overall System Architecture

» Master Data Management

» Serial Number Range Management

» Alignment with current standards (e.g. GS1)

» Indirect Use of coding structures versus direct

use Data carriers

» The use of a GTIN or pseudo GTINs as part of

product code.

» The use of a serial number, which combined

with SKU is unique

» Support of randomized or non-randomized

serial numbers

» Inclusion of the product batch code and pro-

duct expiry date.

» Supported data carriers (2D and/or RFID) and

minimum sizes

» Alignment with current standards (e.g. EPCIS

GS1)

» Types of required communication messages

(e.g. manufacturing, import, decommissio-

ning etc.)

» Required message parameters

» Standardized identification of location and

supply chain actors (e.g. GLNs)

» Communication security and privacy

» Event Handlers

» Capture Interface

» Query Interface

» Misc. Interfaces


» Alert & Exception Handling

» Archiving

» Role & Authorization concept

» Security Requirements

» Connection authentication

» Manufacturer access

» Pharmacy access

» Firewall/Intrusion prevention

» Monitoring

» System Requirements

» Handling high data volumes

» Reliability

» Availability

» Administration

» Response time

» Coding standards

» Constraints

» Health and safety requirements

» Procedural constraints

» Design constraints

» Compatibility

» Maintenance

3 Movilitas Add-On’s for SAP Track & Trace

All the Track & Trace Add-On’s described below were conceived during one of the more than 30 implementati-

on projects (status in 2012) in which Movilitas has implemented item serialization and Track & Trace processes

and systems with customers running SAP.

The value of using those Add-On’s for our customers and partners can be summarized in three points:

1) do not reinvent the wheelThere is no need to re-develop what has already been developed and is in operation at several customers.

Re-using out of the box Add-On’s save project time and mitigates the risks, as the Add-On has already been

implemented, tested and gone live successfully.

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2) supported codingThe problems of customer developments almost always arise in support later down the line (e.g. in future

upgrades they need to be updated to ensure they continue to work with newer versions of other components

and interfaces; in case of problems during operations expert advice is required to solve problems). All of the

Movilitas Add-On’s presented below are supported Add-On’s.

3) no need to engage any movilitas consultants As a partner, when future requirements dictate, one or more of those Add-On’s can be used without having

to involve any Movilitas consultants in the Track & Trace projects. For customer, this allows the freedom of

working with local partners of choice and still leveraging the in-depth Track & Trace knowledge accumulated

by Movilitas.

3.1 Randomization Add-On

brief overview:The Randomization Add-On allows SAP OER to integrate with an external library to produce randomized serial

numbers according to a number of variable parameters.

» who should use it?Any company using SAP OER and needing randomized serial numbers, as randomization is not supported

in standard SAP OER/AII (Version 7.1 or lower). Via the randomizer Add-On, SAP OER can connect to a ran-

domization service and receive back-randomized unique serial numbers, which can then be used for later

processing.

detailed architecture:The Randomization Add-On is comprised of two components:


1. The randomizer ABAP classes which allow for the integration of the external randomizer service out of the

box (no additional ABAP development required). Those classes are delivered as ABAP transports. Depending

on the customer landscape, the Add-On can be installed on the SAP OER system or on the SAP AII system.

2. The randomizer algorithm (an algorithm called BayCoder® (see also chapter V, 3.4.2.9), written by Bayer

Technology Services). The algorithm is a piece of software written in Java that can be installed on any server

supporting Java.

detailed functional description:The following are the key highlights of the product:

01) Each single number generated only once

02) Probability of guessing a valid serial number in any case is more than 1:10.000

03) Serials are equally distributed across the number range

04) The algorithm is not easy to find out even when a the given set of serials or a

subset thereof is known

05) Numeric or alphanumeric codes

06) Length of serial number customizable (max. 30)

07) Java coding, flexible in all system landscapes

08) Initialized by customer using self-chosen parameter values

09) Pre-defined number range is fully exhausted

10) Customer specific parameterization: Third parties not able to generate identical

serial numbers by using BayCoder®

11) High performance: Unique serial numbers generated in less than 1 msec per

number. No impact on production output!

12) No specific hardware required

1.

2.

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3.2 Data Reconciliation cockpit Add-On

brief overview:The data reconciliation cockpit Add-On allows the reconciliation of captured Track & Trace data.

» who should use it?Any corporation that needs to rollout Track & Trace in a number of markets, in a limited timeframe, or any

organization deploying Track & Trace in manufacturing plants and warehouses with heterogeneous processes

and system landscapes. In those cases, the only feasible solution is to put Track & Trace on top rather than

integrating it with existing processes. The advantage of this approach is the speed of deployment, (as existing

processes or systems already in operation are not touched) but the clear downside of it is that, scanning Track

& Trace data is an addition to normal operations and therefore, technically optional (an outbound delivery can

leave the warehouse without the operator scanning the serial numbers of the delivery).

Any customer putting Track & Trace on top requires some level of reconciliation in order to monitor the ac-

curacy of the Track & Trace data collected and in order to measure the scanning performance in the different

locations capturing Track & Trace data.

detailed architecture:The Reconciliation Cockpit Add-On is comprised of two components:

3. The Reconciliation ABAP classes which are delivered as ABAP transports and are to be imported into the

SAP OER system.

4. SAP PI business content (SAP PI Interfaces) that provide the data channels in order to feed the reconciliation

cockpit in SAP OER with reconciliation data.

1.

2.


detailed functional description:The data reconciliation cockpit Add-On provides the following functions. In any of the four main functions

described below, the user can always select by timeframe and location:

a) manufacturing reconciliationVia the manufacturing reconciliation it is possible to monitor the printing and reading accuracy of a given

manufacturing plant. In cases where numbers were printed and scanned on the packaging lines but, never

arrived in SAP OER, these will be highlighted and the missing numbers will be displayed in the SAP OER

reconciliation cockpit. In the scenario where full cases were produced in the packaging lines, but the cases

arrived incomplete (less items than expected in SAP OER) or even empty in SAP OER (e.g. the items to cases

relationship was not created), those incomplete or empty cases are highlighted.

b) logistics reconciliationVia the logistics reconciliation it is possible to monitor the accuracy of the Track & Trace scanning during

delivery processing. For example, if a delivery number was processed in the warehouses, but is not visible in

SAP OER, this will be highlighted in the reconciliation cockpit; or if fewer items were scanned against a deli-

very than what was expected and confirmed based on the delivery line items, this will be highlighted in the

reconciliation cockpit as well.

c) Timestamp reconciliationThe event timestamp is one of the most critical parameters in EPCIS messages. Since the capturing applica-

tions (packaging lines or mobile scanning devices) are generating messages, it needs to be ensured that none

of those devices has the wrong timestamp during operations. Also, every device needs to be registered in the

right time zone and use the correct timestamp terminology to express the timestamp in UTF or local time.

The timestamp reconciliation enables the central monitoring of any of the capturing devices and to define

timestamp deviation thresholds in order to trigger automated alarms should a capturing device go out of

sequence.

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d) logical random checks reconciliationFor any Track & Trace scenario, there is the so-called expected logical sequence. (E.g. an item normally is

first packed in a case, that case on a pallet and that pallet is then shipped). This functionality caters for daily

random checks to be run and to highlight and/or trigger alerts in case a given ID does not follow the logical

sequence of expected event messages (number of randomly checked numbers as well as expected logical

check configurable by location).

3.3 Authorities Reporting Add-On

brief overview:The authorities reporting Add-On allows leveraging on experiences of other companies when connecting their

SAP OER/AII with external authorities. This Add-On is specifically built for the pharmaceutical industry. The

Add-On includes among other things, standard coding to interact with the Ministry of Health (MoH) in Turkey,

with the sFDA in China, and also allows the creation of a pharma ASN based on SAP OER serial number infor-

mation (which can then be used to generate an e-Pedigree document or any other type of electronic Track &

Trace documentation).

» who should use it?Any pharmaceutical company using SAP OER as the EPCIS repository is confronted with the same problem:

reporting to the authorities is compulsory and a key driver for the serialization of SKUs for the country. This

functionality is however not standard in SAP OER (Version 7.1 or earlier versions) and means custom coding

and new complex interfaces in SAP PI.


detailed architecture:The authorities reporting add-on is comprised of two components:

5. SAP OER pre-configured setting (BC Sets) and ABAP Classes which are delivered as Workbench or Customi-

zing transports and are to be imported into the SAP OER system; which allows:

Map Global codes – local codes:

National codes such as the National Chinese Medicine Code or the PZN (Pharmazentralnummer) in Germany

need to be mapped in the central system.

Adapt your number range management to the country requirements:

This Add-On supports various ways of doing number range management (and not only sequential numbers

based on sGTIN). It supports:

a) number ranges import (e.g. china)

b) alphanumeric serial numbers

c) random serial numbers

Extract data from SAP OER:

The data pool is used to extract data for authorities reporting, taking the date from SAP OER.

6. SAP PI business content (SAP PI Interfaces) that allows:

Data formatting, mapping and conversions in SAP PI

Data formatting, mappings and conversions are required to adapt generic reporting to local format require-

ment (e.g. adding Chinese texts for product codes)

1.

2.

199

Audit trail, monitoring and error handling interfaces

Any incoming or outgoing interactions need to be handled as an event handler, so that

a detailed protocol can be created (including re-processing capabilities etc.)

detailed functional description:The following functionalities are provided today out of the box with the delivery of the

Authorities Reporting Add-On:

a) authorities reporting for china - sfda:

» Serial Number request, import and export to the lines

» Master data mapping (GTIN – National Chinese Medicine Code)

» Output formatting for the required messages to the sFDA

» Error handling, audit trail and monitoring of the sFDA Interface

b) authorities reporting for Turkey:

» Output formatting and for the required messages to the Turkey MoH

» Web service integration with the Turkey MoH for message submission

» Error handling, audit trail and monitoring of the Interface

c) Pharma asn:

» Output of enriched ASN with SAP OER serial numbers (triggered by ERP)

» Used as basis for other outputs like e-Pedigree

» Error handling, audit trail and monitoring of the sFDA Interface

d) Pdf report generation for requested Product id:

» Generation of a full Track & Trace record for a given requested ID

» Integration with SAP connect so that e-mail with PDF report is created

» User registration, report versions and white/black lists


3.4 The special events Add-On

brief overview:The Special Events Add-On provides transactions that will allow product Ids to be marked

as „stolen“, „missing“, „contraband“, „counterfeit“ or „seized“.

This add-on comprises in total three abaP transactions:

» Mark Product IDs as stolen

» Mark Product IDs as missing

» Upload Product IDs scanned during a seizure

» who should use it?Any company running Track & Trace with a need to flag products as stolen, missing, counterfeit or contraband

under special circumstances. This functionality is mainly used in exception events (e.g. full shipment stolen).

This functionality is not standard in SAP OER.

detailed architecture:The special events Add-On is comprised of a single component:

7. ABAP transaction and classes which are delivered as ABAP transports and are to be imported into the SAP

OER system. All three special transactions mentioned are delivered as new transaction codes to be used

within the SAP OER system (ABAP transactions executed from the SAP GUI).

1.

201

detailed functional description:The following three transactions are added as a part of this Add-On:

a) stolen goods transactionWhenever goods are stolen, typically the only information available is a reference delivery number (or the

shipment number and from there it is possible to find out the affected deliveries in your ERP system). This

transaction allows users to enter a delivery number; the transaction then displays all pallets, cases and items

contained in that delivery with the corresponding hierarchies. It is then possible to select one or more of the

pallets, cases or items contained in the delivery and create a special event called “stolen”. When this event is

posted against the Event Handler, the status then changes to “Stolen”.

b) missing goods transactionSometimes the received quantities do not matched the shipped quantities. In those scenarios, the only so-

lution is to flag those disappeared product IDs as missing. This transaction allows entry of two reference

document numbers (e.g. and outbound deliver and the inbound delivery); the transaction then displays the

differences only (e.g. all pallets, cases and items contained in the outbound delivery but not scanned during

the inbound delivery processing. It is then possible to select one or more of the pallets, cases or items and

create a special event called “Missing”. When this event is posted against the Event Handler, the status then

changes to “Missing”.

c) Product seizures transactionDuring project seizures, inspectors collect serial numbers, inspect them and come to conclusions. This tran-

saction allows the documentation of any seizure activity; by allowing the import of an Excel file with the coll-

ected numbers (any formats etc. are checked), highlighting ID numbers if the numbers uploaded exists in the

SAP OER repository or are new and then posting event messages against the affected IDs flagging them as

seized, contraband or counterfeit in the SAP OER database (new event created in addition to the change of

the Event Handler attribute accordingly).


3.5 The Performance Test Add-On

brief overview:The performance test Add-On provides all the transactions required to run stress and performance testing in

a landscape, simulating future expected data volumes. Two types:

A) SAP OER – performance and stress test

B) End to End – performance and stress test

» who should use it?Any corporation implementing SAP OER and expecting large amounts of future data should ensure that the

implementation of the SAP OER repository fulfills the performance requirements. This exercise is a must mi-

lestone on any SAP OER implementation. The risk of not performing this test during the initial implementation

is that, further down the line, the SAP OER repository may not cope with the serialized items sent by the pa-

ckaging lines and the entire landscape might have to be redesigned (normally, the ramp-up phase for any cus-

tomer to achieve high data volumes is 1 to 2 years depending on the implementation of the packaging lines,

software and hardware). A performance test is key for customers with enhancements or specific configurations

of SAP OER (e.g. long tracking IDs or many event handler attributes). In general any ABAP enhancement in

SAP OER that has not been performance tested (due to the high volumes expected on any SAP OER system)

has a probability of 90% to fail (e.g. timeout) as soon as the repository starts receiving larger volumes of data.

detailed architecture:The Performance Test Add-On is delivered in two packages:

8. ABAP package (as ABAP workbench transports) – contains the ABAP classes and transactions that are nee-

ded in order to generate IDs (configurable) and in order to measure database performance during the test

execution.

9. .Net executable: which contains a program used for ID generation (configurable) used during End to test.

1.

2.

203

detailed functional description:Normally performance is first tested end to end in the repository itself (to ensure that the expected volumes

can be handled), in order to ensure that the SAP PI landscape or WAN network can handle the expected volu-

mes. Both tests are fundamental and for both tests tools are required for execution as well as for performance

measurement. Therefore, the following functions are delivered:

a) Performance test execution » SAP OER ABAP program to generate high volumes of different IDs and event message types within SAP OER

(not end to end). EPCIS Messages are sent to SAP OER within the ABAP proxy. The attributes, types of IDs

and types of messages to be generated and sent are configurable via the customizing tool.

» .Net program to generate high volumes of different IDs and event message types outside of SAP OER. Ge-

nerated EPCIS messages are then sent via the SAP PI web service interface to SAP OER (End to End). The

attributes, types of IDs and types of messages to be generated and sent are configurable via the customi-

zing tool.

b) Performance test measurements » SAP OER ABAP set of reports that measure the database performance when writing data in SAP OER and

generated various ratios and statistics (e.g. Number of Event Handlers created per minute).


3.6 The Archiving Add-On

brief overview:The SAP OER data archiving Add-On is a holistic package to implement SAP OER archiving. (OpenText is part

of the prepackaged standard offering).

» who should use it?Any corporation using SAP OER and handling high data volumes should have an archiving strategy. The main

reason is that in most industries, data retention policies are around 10 years. However, there is no real need

to keep IDs in the active database once no further EPCIS messages are expected for those IDs. For this reason

most customers archive data after one or two years. This data can still be retrieved at any time, however it does

not reside in the active database (archived data is deleted from the SAP OER active database once archived).

detailed architecture:The archiving Add-On is delivered in two packages:

10. SAP OER Configuration transports, which configure the archiving objects in the SAP OER system and prepa-

res the system to support archiving (standard business content in SAP OER).

11. Underlying archiving system (extra archiving server normally required), which builds the platform for the

physical data archiving and is connected to SAP OER via the standard ArchiveLink interface.

detailed functional description:

Most of this functionality is standard in SAP OER. Thus, the Add-On needs to be understood as an accelerator

to configure and implement archiving twice as fast and risk free (leveraging previous experiences around data

archiving with SAP OER.

1.

2.

205

There are four main functionalities provided by this add-on: » Data flagging and selection for archiving (Event Handlers and Event Messages)

» Data writing on the archive file and further posting in the archive system

» Data deleting from the SAP OER active database

» Data retrieval test (customer specific as this always depends on the type of data consumption)

3.7 ECPIS Repository migration Add-On

brief overview:The EPCIS Repository Add-On allows the extraction of an entire database from SAP OER into EPCIS format, so

that this data can be seamlessly migrated to a different EPCIS directory.

» who should use it?Any customer migrating from SAP OER7.0 to SAP OER7.1 or any customer migrating from SAP OER7.0 or SAP

OER7.1 to another non SAP EPCIS repository.

detailed architecture:This Add-On is delivered as an ABAP transport that contains the required ABAP classes and transactions, not

only to extract data from SAP OER structures back into EPCIS messages but also to monitor the migration run

(this functionality is only available for SAP to SAP migration and not for SAP to non-SAP migrations).

detailed functional description:The add-on contains functionality to:

A) Extract data from SAP OER structures back into EPCIS messages

B) Monitor the data extraction process (e.g. Statistics)


3.8 The Industrial mobile scanning Add-On

brief overview:The industrial mobile scanning Add-On allows the use of industrial scanners (e.g. Motorola or Intermec de-

vices) to capture events and to send them in EPCIS format directly to SAP OER. The Add-On provides over 20

different mobile transactions (goods receipts, goods dispatch, aggregate, disaggregate, decommission, etc.)

and it works offline/online (so not even a Wi-Fi infrastructure is required in the locations where it is deployed).

All that is required to send data is a connection to the Internet (no special VPN required etc.).

» who should use it?Any company with the need to deploy Track & Trace to many locations with heterogeneous infrastructure and

possibly even with different system landscapes, as well as any corporation having to fulfill aggressive timelines

in deploying Track & Trace in those sites. It is also a must have for those companies deploying Track & Trace

to external agents. In all cases, investing in process harmonization (in order to integrate Track & Trace within

current logistic processes) and investing in the required infrastructure in the sites is normally not practicable.

Deploying this industrial mobile scanning solution capable of capturing and sending any kind of EPCIS events

without any changes in the current processes or infrastructure (Track & Trace on top) is the most appropriate

approach in all the scenarios considered.

detailed architecture:The Movilizer for Track & Trace (see also chapter V, 3.6) is an SAP certified Add-On that is delivered as an ABAP

Add-On which can be imported in to the ABAP stack of SAP PI or SAP OER. The Movilizer Connector (delivered

as a part of the Movilizer for Track & Trace ABAP package) connects the corporate system with the mobile de-

vice via the Movilizer Cloud, which allows mobile customers to send EPCIS messages from any device running

the Movilizer client with the right credentials (and send messages via a simple internet connection)

207

on the mobile device:

• Goods receipt

• Goods receipt and palletize

• Goods dispatch

• Pack (items, bundles, cases, pallets etc.)

• Unpack (items, bundles, cases, pallets etc.)

• Decommission

• Merge pallets

• Unload and dispatch

• Break bundles, cases, pallets, etc.

• Print labels

• Print KPIs

• View deliveries/transfer orders

• Edit scanned transactions

• Display scanned transactions

• Helpdesk info

• Change language

• Logon/Log Off

• Synchronize

on the movilizer connector:

• Configure user roles per location

• Configure scanner functionalities and

behavior per location

• Configure EPCIS message packaging

• Configure EPCIS conversion rules

• Configure user logon and device details

per location

• Configure location dependent helpdesk

• Configure handhelds and time dependent

settings

• Configure Movelets (sequence of screens)

• Configure scenarios

detailed functional description:The following functions are delivered out of the box as part of this Add-On:


3.9 The mobile app for event capturing, ID verification and more

brief overview:An app for event capturing and ID verification that allows smartphones to be used.

» who should use it?Any company willing to use smartphones in order to capture EPCIS events and verify ID’s against any type of

EPCIS repository (and of course against SAP OER). In particular, those companies willing to connect external

agents to the EPCIS repository will require this Add-On, as it would allow them to provide a mobile app sup-

porting any major smartphone or tablet (iPhone, iPad, Android, etc.) capable of using the smartphone camera

as a barcode scanner and able to send data via the internet (no VPN or additional software required).

detailed architecture:Please refer to chapter VI, 3.8


The following functions are delivered out of the box as part of this add-on:

On the mobile device (ID verification):

• Verify ID (Synchronously)

• Verify ID (Asynchronously)

• Get ID details (header, event messages

and hierarchy)

on the mobile device (ePcis event capturing):

• PleaserefertochapterVI,3.8

on the movilizer connector:

• PleaserefertochapterVI,3.8

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3.10 The logistics label printing Add-On

brief overview:

The logistics label printing add-on allows:

A) Advanced label printing as well as the design of labels and input forms. This Add-On would normally

be used in connection with fixed printers and especially useful in logistic operations, where operators

need to be able to print new labels during rework operations. The advantage of this approach is that

it does not require any footprint at all.

B) Basic label printing triggered directly from the mobile device and printed via a Bluetooth printer.

» who should use it?Any companies completing re-work in warehouses or distribution centers (re-work meaning: having to create

new aggregations and therefore having to print new IDs) will need this functionality. Also companies running

re-labeling operations across the supply chain (it does not matter where) may use this Add-On to generate

and print out unique IDs from a mobile scanner. Several customers have also used this solution in order to

avoid implementing serialization on a whole packaging line, if only a small amount of SKUs with low volumes

have to be serialized for a given market. For a small amount of IDs per year, a manual relabeling of cases can

save significant costs.

detailed architecture:The label printing Add-On does not require any local footprint.

The advanced label-printing suite (based on a third party underlying label printing technology) is running on

the Movilizer Cloud and can be accessed via the Internet (provided the required credentials: user/password/

token, are known). It supports over 2,000 printer models and does not require any other software than an

Internet Explorer browser and Silverlight in order to work.


The basic label printing capability, only requires a mobile device connected to a mobile printer via Bluetooth.

Handhelds are able to print labels even in offline operation.


The advanced label-printing suite provides the

following functions:

• Generation of IDs offline or online

• Certified connector for SAP for master data

• Able to work in pure offline environments

• Support of 2,000+ printers

• Installation via internet browser

(no local footprint)

• Print new labels for items

• Print new labels for bundles

• Print new labels for cases

• Print new labels for pallets

• Multi-language support

• Label repository and configuration per location

• Central repository for label layouts and input forms

• Location dependent input forms for ID

generation

• Label reprint for items, bundles, cases or

pallet labels

• Etc.

The basic label-printing capability provides the

following functions:

• Generation of IDs offline or online

• Print new labels for items

• Print new labels for bundles

• Print new labels for cases

• Print new labels for pallets

• Multi-language support

• Printing on mobile printers via Bluetooth

printers (limited printer models supported)

• Limited layout capabilities

• Flexibility when designing input forms for

label generation

• Label reprint for items, bundles, cases or

pallet labels

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3.11 The lean Track & Trace Add-On

brief overview:The lean Track & Trace Add-On allows companies with low volume serialization requirements (e.g. most logi-

stic providers without manufacturing operations) to enable their existing SAP ERP systems to act as an EPCIS

repository for low volume Track & Trace data.

» who should use it?Mainly suitable for logistic providers under pressure to provide Track & Trace services for their customers

(mainly manufacturers). Often, logistic providers mainly handle cases and pallets and bundles and only in ex-

ceptional cases at item level. For those requirements, setting up a full scale SAP OER system (including SAP PI

etc.) might not be practicable. Thus, this Add-On allows any customer using an SAP ERP (ECC6.0 or higher) to

have a Track & Trace enabled SAP ERP (including EPCIS interface in order to receive messages).

detailed architecture:This Add-On contains two parts:

12. ABAP transports to be imported in to the existing SAP ERP environment, containing the logic to act as an

EPCIS repository.

13. Mobile scanning transactions capable of capturing EPCIS event and sent onto SAP ERP.

1.

2.



a) on saP erP:

• EPCIS interface for SAP ERP

• Event handler and event messages

data structures

• Basic reporting functionality

(ABAP reports and statistics)

• Serialized ASN processing interface

(for integration with manufacturer ASN)

b) mobile scanning transactions:

• On the mobile device (EPCIS event capturing):

Please refer to chapter VI, 3.8

• On the Movilizer Connector:

Please refer to chapter VI, 3.8

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3.12 The 2cd level support package Add-On

brief overview:The Movilitas 2cd level support package Add-On ensures worry-free operations for SAP Track & Trace systems.

This package allows you to access the 24*7 support helpdesk in order to identify and solve any problems that

might occur in the Track & Trace landscape. With the exception of packaging lines, this package covers any

other components: SAP OER, SAP PI, SAP AII and of course any of the other Movilitas Add-On’s.

» who should use it? Any company running SAP Track & Trace that do not have a dedicated support team with deep knowledge on

SAP OER, SAP AII, SAP PI, Label Printing or Mobile scanning solutions.

detailed functional description:Support package provides modular support for any of the following components:

• SAP OER

• SAP PI

• SAP AII

• Movilizer scanning solution

• Movilizer printing solution

• Any of the Movilitas Add-On’s.

The level of support can be configured by the customer on demand.

214 Authors

Authors

Stefan Hockenberger,

Director Business Unit Track & Trace and Marketing, Movilitas Consulting AG

Master of Business Administration stefan hockenberger studied business administration in the “Berufsaka-

demie Mannheim”, University of Cooperative Education. From 2002 to 2009 Stefan worked as Solution Sales

Executive at SAP Germany AG & Co. KG and had the overall Pre-Sales responsibility for the “SAP Solutions for

item Serialization (SAP AII/OER)” within all industries in Germany, Austria and Switzerland. Since 2009 Stefan

has been responsible for Marketing and the business unit Track & Trace at Movilitas Consulting AG.

Karl Christian Roediger,

SCM Solution Management, SAP AG (Chapter II – SAP’s vision of Track & Trace – an introduction from the

world’s largest supplier of standard software)

karl christian roediger who joined SAP in 2001, is a Solution Manager in the SAP Supply Chain Management

Solutions Area. Since joining SAP, Chris has worked chiefly in the SAP Supply Chain Execution and SAP Auto-ID

solution areas and helped in shaping products such as SAP Auto-ID Infrastructure, SAP Object Event repository

and the forthcoming new SAP Global Batch Traceability. Chris was awarded an MBA by Henley Management

College, UK (now Henley Business School as part of the University of Reading) in 2000.

Prior to joining SAP, Chris can look back on a 17 year long career in international logistics operation and ma-

nagement with multi-year assignments to international location such as Germany, UK, Hong Kong and China.

215

gs1 healthcare (chapter iii - gs1 standards for Track & Trace)

GS1 Healthcare is a global, voluntary user community bringing together all Healthcare supply chain sta-

keholders, including manufacturers, distributors, Healthcare providers, solution providers, regulatory bodies

and industry associations. The mission of GS1 Healthcare is to lead the Healthcare sector to the successful

development and implementation of global standards by bringing together experts in Healthcare to enhance

patient safety and supply chain efficiencies.

GS1 Healthcare members include over 60 leading Healthcare organizations worldwide. For more information

about GS1 Healthcare, please visit www.gs1.org/healthcare.

Alberto Zamora Pueyo,

Member of the Board, Movilitas Consulting AG (Chapter IV, 2 - Beyond compliance: potential benefits of

Track & Trace & Chapter VI, 3 – Movilitas Add-On’s for SAP Track & Trace)

alberto Zamora Pueyo, born in 1976 in Huesca (Spain) holds a degree in communication sciences (Univer-

sidad Pontificia de Salamanca, Spain), a degree in economics (Universidad a Distancia, Spain) and a degree

in informatics engineering (Hochschule Heidelberg, Germany). Prior to co-founding Movilitas in Mannheim

(Germany) in 2006, Alberto worked for a 5 year period in Germany at SAP SI and SAP AG and for one and a half

years at SAP UK, always in positions related to mobility in the supply chain and SAP Track & Trace. Working in

the area of Track & Trace since 2006, Alberto has been playing key roles in 25 Track & Trace projects. Among

others he has worked with 10 out of the worldwide top 25 pharmaceutical companies, with 2 out of the 4

worldwide tobacco manufacturers. Today Alberto is a Principal Track & Trace consultant at Movilitas as well as

a board member and is based in London.

216 Authors

Pharma iQ (chapter iv, 1.1 - Pharmaceutical industry)

Pharma IQ, a division of IQPC, is an international online community focusing on providing pharmaceutical

professionals with knowledge, information and articles. They are dedicated to creating a learning environment

for sharing ideas, best practices and solutions within the pharmaceutical community - www.pharma-iq.com.

Yannick Hofmann,

Chief Executive Officer, Xavo Systems AG (Chapter V, 3.1 Printing Technologies for T&T

related marking activities)

yannick hofmann, born in 1983, studied Economy at University of Bayreuth, Germany. He subsequently spe-

cialized in IT and has worked at Xavo since 2005, first as Quality Manager and subsequently as Business Con-

sultant and Project Manager. Since 2008 Yannick has worked as Manufacturing Test Lead within a Pilot Project

for a globally re-usable Tracking and Tracing Solution in the Tobacco Industry. Today, Yannick is a Business

Consultant responsible for global System Roll-out, including Development and Pre-Test of manufacturing IT-

Systems. Since 2009 Yannick Hofmann is Chief Executive Officer entrusted in the management and Sales for

Xavo Systems AG, Switzerland.

217

Frederic Menardo,

General Manager Europe, Systech (Chapter V, 3.2 - Processes, Considerations and Software at production/pa-

ckaging lines)

frederic menardo has been the General Manager Europe for Systech International for the past 4 years, hol-

ding responsibility for the company‘s European operations. Frederic is an executive member of the Systech

serialization deployment steering committee for global customers. Prior to joining Systech, Frederic served in

various management functions at European level with Johnson & Johnson, Esko-Graphics and Kodak.

Dr.-Ing. Stefan Artlich,

Director Supply Chain Optimization, Bayer Technology Services GmbH (Chapter V, 3.4.2.9 – Serialization vs.

Randomization)

stefan holds a diploma in mathematics from University of Bonn and a Ph.D. in chemical engineering from the

Technical University of Hamburg-Harburg. Stefan joined Bayer in 1996 and now holds a position as Director

Product Tracking and Authentication. Since 2008, he has been involved in the “Coding and Serialization” ac-

tivities of both Bayer HealthCare AG and the European Federation of Pharmaceutical Industries and Associa-

tions (EFPIA). Stefan initiated the development of BayCoder (R) at BTS. Currently he supports EFPIA’s activities

towards design and implementation of a pan-European medicines verification system.

218 Definitions, Acronyms and Abbreviations

Definitions, Acronyms and Abbreviations

anvisa| Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)

anmaT| Administratión Nacional de Medicamentos, Alimentos y Tecnologia Médica (National Health

Organization Argentina)

GS1-128 uses a series of Application Identifiers to include additional data such as best before

dates, batch numbers, quantities, weights and many other attributes.

asn| An Advance Ship Notice or Advance Shipping Notice (ASN) is a notification of pending deli-

veries, similar to a packing list. It is usually sent in an electronic format and is a common EDI

document.

badi| Business Add Ins are enhancements to the standard version of the code of SAP. They can be

inserted into the SAP system to accommodate user requirements too specific to be included

in the standard delivery.

cgmP| (current) Good Manufacturing Practice regulations (GMPs) are used by pharmaceutical, medi-

cal device, and food manufacturers as they produce and test products that people use. Drug

GMPs also apply to the veterinary drugs.

French Club Inter Pharmaceutique, which comprises of manufacturers, distributors, agents,

organizations representing pharmacies, biological systems as well as hospital pharmacists

and performs the function of a technical expert for the French Health sector.

A two-dimensional barcode such as e.g. Datamatrix.

ai (application

Identifier)|

ciP (club inter

Pharmaceutique)|

data matrix code|

219

datamatrix| A two-dimensional matrix barcode consisting of black and white „cells“ or modules arranged

in either a square or rectangular pattern. The information to be encoded can be text or raw

data.

desadv| Dispatch Advice Message

din| Deutsches Institut für Normung e.V. (in English, the German Institute for Standardization)

is the German national organization for standardization and is that country‘s ISO (see ISO)

member body. DIN is a Registered German Association (e.V.) headquartered in Berlin. There

are currently around thirty thousand DIN Standards, covering nearly every field of technology.

ean| An EAN-13 barcode (originally European Article Number, but now renamed International

Article Number even though the abbreviation EAN has been retained) is a 13 digit (12 data

and 1 check) barcoding standard which is a superset of the original 12-digit Universal Product

Code (UPC) system developed in the United States. The EAN-13 barcode is defined by the

standards organization GS1.

ecom| eCom is a GS1 term used for the Electronic Data Interchange. GS1 eCom provides global stan-

dards for electronic business messaging that allow rapid, efficient and accurate automatic

electronic transmission of agreed business data between trading partners.

ePc| The Electronic Product Code is designed as a universal identifier that provides a unique iden-

tity for every physical object anywhere in the world, for all time. Its structure is defined in the

EPCglobal Tag Data Standard, which is an open standard freely available for download from

the website of EPCglobal, Inc.


ePcis| EPC Information Services (EPCIS) is an EPCglobal standard designed to enable EPC-related

data sharing within and across enterprises. This data sharing is aimed at enabling participants

in the EPCglobal Network to obtain a common view of the disposition of EPC-bearing objects

within a business context.

ePcglobal| EPCglobal is leading the development of industry-driven standards for the Electronic Product

Code (EPC) to support the use of Radio Frequency Identification (RFID) in today’s fast- mo-

ving, information rich, trading networks.

e-Pedigree| An electronic document, typically in XML format, containing the history of custody.

efPia| European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussels-

based trade union founded in 1978 representing the research-based pharmaceutical indus-

try operating in Europe. Through its direct membership of 31 national associations and 44

leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,200 companies

committed to researching, developing and bringing new medical treatments.

fcTc| The WHO Framework Convention on Tobacco Control (WHO FCTC) is the first treaty negot-

iated under the auspices of the World Health Organization. The WHO FCTC is an evidence-

based treaty that reaffirms the right of all people to the highest standard of health.

fda| The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health

and Human Services.

fdaaa| On September 27, 2007, President George W. Bush signed the Food and Drug Administration

Amendments Act (FDAAA) of 2007 into law. This new law is an important step for the Food

and Drug Administration (FDA). It reviewed, expanded, and reaffirmed several existing pieces

of legislation regulating the FDA. These changes will allow the FDA access to much-needed

221

resources that will enable the agency to better protect American consumers by allowing more

comprehensive reviews of potential new drugs and devices.

feem| The Federation of European Explosives Manufacturers is a non-governmental organization

created in 1976 by European industrial explosives manufacturers. The main objective of the

Federation is to encourage best practice in the industry, particularly in the areas of safety,

quality and security, and to make the public aware of the importance of different uses of in-

dustrial explosives in creating its infrastructure and environment.

gamP| Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the

International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manu-

facturers and users of automated systems in the pharmaceutical industry.

gdsn| The Global Data Synchronization Network (GDSN) is built around the GS1 Global Registry,

GDSN-certified data pools, the GS1 Data Quality Framework and GS1 Global Product Classi-

fication, which when combined provide a powerful environment for secure and continuous

synchronization of accurate data.

gln| The Global Location Number (GLN) is part of the GS1 systems of standards. It is a simple tool

used to identify a location and can identify locations uniquely where required.

grai| The Global Returnable Asset Identifier (GRAI) is part of the system of GS1 standards. It is a

simple tool to identify assets by type and can uniquely identify assets where required.

gs1| GS1 (www.gs1.com) is a leading global organization dedicated to the design and implemen-

tation of global standards and solutions to improve the efficiency and visibility of supply and

demand chains globally and across sectors. The GS1 system of standards is the most widely

used supply chain standards system in the world.


gTin| Global Trade Item Number (GTIN) is an identifier for trade items developed by GS1. Such

identifiers are used to look up product information in a database (often by inputting the

number through a bar code scanner pointed at an actual product), which may belong to a

retailer, manufacturer, collector, researcher, or other entity.

isa-95| ANSI/ISA-95, or ISA-95 as it is more commonly referred, is an international standard for de-

veloping an automated interface between enterprise and control systems. This standard has

been developed for global manufacturers. It was developed to be applied in all industries,

and in all sorts of processes, like batch processes, continuous and repetitive processes.

iso| The International Organization for Standardization, widely known as ISO, is an international

standard-setting body composed of representatives from various national standards organi-

zations. Founded on February 23, 1947, the organization promulgates worldwide proprietary,

industrial, and commercial standards. It has its headquarters in Geneva, Switzerland.

iso 9001| ISO 9001:2008 Quality management systems — Requirements is a document of approximate-

ly 30 pages, which is available from the national standards organization in each country. It

is supplemented by two other standards, ISO 9000:2005 Quality management systems —

Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an

organization.

mes| Manufacturing Execution Systems are information technology systems that manage manu-

facturing operations in factories. Over the years, international standards and models have

refined the scope of such systems in terms of activities.

moh| Ministry of Health

ndc| The National Drug Code (NDC) is a unique product identifier used in the United States for

223

drugs intended for human use. The Drug Listing Act of 1972 requires registered drug estab-

lishments to provide the Food and Drug Administration (FDA) with a current list of all drugs

manufactured, prepared, propagated, compounded, or processed by it for commercial distri-

bution. Drug products are identified and reported using the NDC.

oee| Overall equipment effectiveness (OEE) is a hierarchy of metrics developed by Seiichi Nakajima

in 1960‘s (based on Harrington Emerson way of thinking regarding to labor efficiency), which

evaluates and indicates how effectively a manufacturing operation is utilized

oPc| The Open Packaging Conventions (OPC) is a container-file technology initially created by

Microsoft to store a combination of XML and non-XML files that together form a single entity

such as an Open XML Paper Specification (OpenXPS) document.

Pes| Packaging Execution System

Plc| A programmable logic controller or programmable controller is a digital computer used for

automation of electromechanical processes, such as control of machinery on factory assem-

bly lines, amusement rides, or light fixtures.

Qa| Quality assurance refers to the planned and systematic activities implemented in a quality

system so that quality requirements for a product or service will be fulfilled.

rfid| Radio-frequency identification (RFID) is the use of an object (typically referred to as an RFID

tag) applied to or incorporated into a product, animal, or person for the purpose of identifi-

cation and tracking using radio waves.

scada| Supervisory Control And Data Acquisition generally refers to industrial control systems (ICS):

computer systems that monitor and control industrial, infrastructure, or facility-based pro-

cesses.


sfda| State Food and Drug Administration, P.R. China

sgTin| Serialized Global Trading Item Number (sGTIN) a global trade item number combined with a

serial number.

sni| Standardized Numerical Identification

soP| A Standard Operating Procedure is a written document or instruction detailing all steps and

activities of a process or procedure. ISO 9001 essentially requires the documentation of all

procedures used in any manufacturing process that could affect the quality of the product.

sscc| The Serial Shipping Container Code (SSCC) is the GS1 Identification Key for an item of any

composition established for transport and/or storage, which needs to be managed through

the supply chain. The SSCC is assigned for the life time of the transport item and is a manda-

tory element on the GS1 Logistic Label using Application Identifier (00)

vds| VdS is an independent institution which has been ensuring safety and trust in the fields of fire

protection and security for many decades and develops advanced safety concepts for signifi-

cant industrial and commercial enterprises, leading manufacturers and system businesses as

well as specialist firms and independent specialists.

who| The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that

acts as a coordinating authority on international public health.

xml| Extensible Markup Language is a markup language that defines a set of rules for encoding

documents in a format that is both human-readable and machine-readable. It is defined in

the XML 1.0 Specification produced by the W3C, and several other related specifications, all

gratis open standards.

225Appendix

Appendix

1 Track & Trace Survey - Overview

The survey was designed to be answered by a variety of industries. All in all, it contains 39 questions on the

following areas:

• Company and Person

• Item serialization/Track & Trace in general

• Use of Track & Trace data

• Standards

• Software & Service provider

• Budget

• Software

• Project

The survey was sent to 367 recipients and 29 answers were received, which is a return rate of 7,9%. For the

results of the survey (static and dynamic) please refer to Appendix 3. and 4.

226 Appendix

2 Overview Survey Questions

company and Person

• What is your role/job title?

• What is your department?

• What was approximately your organizations 2010 revenue?

• How many employees does your company approximately have?

• Please select the industry that describes your organization

item serialization/Track & Trace in general

• How long has your company had a Track & Trace initiative in place?

• What is/are for your company the main driver(s) for Track & Trace?

• In which of the following areas do you (or will you) use item serialization?

• Please give us a rough estimation of your number of facilities/plants and in how many of

them you already use or plan to use item serialization and Track & Trace.

• If you are already dealing with serialization/Track & Trace, on which level are you tracking?

• On which level do you plan to track in future?

• Is your organization affected by counterfeits and if yes how high are the losses?

• How is your organizations board level aware of item serialization/Track & Trace and

the related meanings and outcome?

use of Track & Trace data

• The serialized information stored in your EPCIS repository, is it for internal purposes only or

do you have to share these information?

• Are your Track & Trace data integrated in existing software applications, e.g. SAP ERP?

• How long do you have to store serialized information in a global repository?

(Please also indicate a time frame if not yet required, but will in future)

• What are you doing with the serialized information after storing in a repository?

227

• How many serialized items do you already store in a repository each year?

• What’s your forecast of serialized items to store in a repository once you reach global coverage?

• How many event messages are generated over an items lifecycle in average by today?

(E.g. produced, shipped, stored, etc.)

• How many event messages will be generated over an items lifecycle in average in future?

(E.g. produced, shipped, stored, etc.)

standards

• How familiar are you with EPC Global and standards like EPC & EPCIS?

• How important is it for your organization to follow EPC Global standards in the area of Track & Trace?

• If you have industry specific standards differing from EPC Global standards can you please shortly

summarize?

software & service Provider

• Please select the top criteria for your organization to select a software provider for a global

Track & Trace repository

• Please select the top criteria for your organization to select a service provider to help you in

implementing a global repository and defining related business processes

budget

• What is your organization‘s approximate 2011 budget for item serialization/Track & Trace?

• How has your organization‘s 2011 Track & Trace budget changed from the 2010 budget?

• How will your organization‘s 2012 Track & Trace budget change from the 2011 budget?

• By when do you think you will reach ROI on your investments for serialization/Track & Trace?

228 Appendix

software

• If you already have Track & Trace in place or plan to have did you or do you plan to separate the topic

of serialization at production lines from the tracking and tracing of the items in the supply chain?

• Do you have already serialization technology at your production lines?

• Do you already have an EPCIS repository in place (e.g. SAP OER)?

• Do you have or plan to have local/regional consolidation software for serialized information

(e.g. SAP AII)?

• Do you have or plan to have a mobile application for capturing event information along the

supply chain?

• How important is it for your organization to integrate event information from the external supply

chain in your repository?

• How important is it for your organization to have an easy to use and easy to integrate mobile application

for event capturing along the supply chain?

• How important is it for your organization that the mobile application offers out of the box features

for Track & Trace?

Project

• Please identify the three most important topics in a Track & Trace project to handle with

• What do you think is the most important to succeed with a global Track & Trace project?

229

3 Track & Trace survey - static results

1. company and Person

roles/job Titles:

• Project manager

• Solution Architect

• Compliance Manager

• General Manager

• Regulatory Intelligence Manager

• Divisional Controller

• Principal Scientist Packaging

• Global Coordination Auto-ID Affairs

• Research Assistant

• Distribution Manager

• IT Lead Serialization & Product Tracking

• Program Manager Serialization

• Track & Trace Manager

• Non Conformance Manager

• Materials Management

• Business Analyst

• Supply Chain Strategy & Design Manager

employees of organizations

• Max: 137.000

• Min: 10

• Average: 36.161

departments:

• Corporate

• Standard Technologies

• SCM IT

• Brand Protection

• Regulatory Affairs

• Engineering Systems

• Executive Board

• Pharmaceuticals Track & Trace

• Export

• Technical Operations

• Technology Management

• Pharmaceuticals Logistics

• Customer Service

• IT

• Production Execution

revenue of organizations

• Max: 60 Billion €

• Min: 10 Million €

• Average: 8.821 Billion €

230 Appendix

» Please select the industry that describes your organization.

Number of Answers Answers

0 Automotive1 Chemicals1 Food/Beverage3 Health/medical 0 Military0 Oil & Gas11 Pharmaceutical 1 Retail12 Others (please explain): Service Providers, Office Equipment, Aviation, Trans-

portation, 3rd Party integrated solutions, Logistics & Distribution, Tobacco, Ag-

riculture Business

2. item serialization/Track & Trace in general

» how long has your company had a Track & Trace initiative in place?


9 More than 5 years5 3 to 5 years3 2 years0 1 year 2 Less than 1 year2 We are about to start right now5 We plan to start in future 1 No plans to start with Track & Trace2 Don’t know

231

» what is/are for your company the main driver(s) for Track & Trace?

Number of Answers (multiple answers were possible)

Answers

19 Comply with government mandates/legislations9 Comply with requirements given by supply chain partners and/or customers15 Business benefits such as transparency/visibility11 Customer service such as patient safety or others6 Reduce cost8 Better security14 Anti counterfeiting 5 Others1 Don’t know

» in which of the following areas do you (or will you) use item serialization?

Number of Answers (multiple answers were possible)

Answers

21 Manufacturing/Production15 Warehouse13 Shipping10 Receiving15 Distribution Centers14 Internal Supply Chain13 External Supply Chain 6 Others1 Don’t know

232 Appendix

» Please give us a rough estimation of your number of facilities/plants and in how many of them you already use or plan to use item serialization and Track & Trace.

Answers Answers

Max: 500Min: 1Average: 81,3 Number of Facilities/Plants of your organizationNot representive In how many do you already use item serialization/Track & TraceNot representive In how many do you plan to use item serialization/Track & TraceNot representive Don’t know

» if you are already dealing with serialization/Track & Trace, on which level are you tracking?


4 Item level0 Case level0 Pallet level0 Container Level2 Don’t know

» on which level do you plan to track in future?


22 Item level3 Case level1 Pallet level0 Container Level2 Don’t know

233

» is your organization affected by counterfeits and if yes how high are the losses?

Number of Answers Answers7 We are not affected by counterfeits7 We are affected, but have no figure0 Less 1% of revenue1 1-2% of revenue0 2-5% of revenue3 5-10% of revenue2 10-20% of revenue1 More than 20% of revenue8 Don’t know

» how is your organizations board level aware of item serialization/Track & Trace and the related meanings and outcome?

Number of Answers Answers0 They never heard of it1 Not aware2 They are aware, but don’t know about meanings and outcome14 The are aware and know about meanings and outcome7 I don’t know about awareness, but they support Track & Trace0 Others5 I don’t know

234 Appendix

3. use of Track & Trace data

» The serialized information stored in your ePcis repository, is it for internal purposes only or do you have to share these information?

Number of Answers (multiple answers

were possible)

Answers

6 We only use the data internal2 We will use this data only internal also in future7 We have to share these data with external resources such as authorizations due

to legislations10 We plan to share these data with external resources such as authorizations due

to legislations5 We already share these data with external resources such as partners for opti-

mization8 We will share these data in future with external resources such as partners for

optimization4 Others5 I don’t know

235

» are your Track & Trace data integrated in existing software applications, e.g. saP erP?


were possible)

Answers

7 No, we just store serialized information in a standalone repository10 Yes, we use event information to trigger logistic transactions such as goods

issue posting, or others in internal systems6 Yes, we use event information to sending information in external software sys-

tems, e.g. proof of delivery4 Others6 Don’t know

» how long do you have to store serialized information in a global repository? (Please also indicate a time frame if not yet required, but will in future)


2 Less than one year7 2-5 years6 5-10 years3 More than 10 years2 We are not forced to store serialized information for a certain time, but plan to

store data for indefinite years1 Others8 Don’t know

236 Appendix

» what are you doing with the serialized information after storing in a repository?


14 Archived6 Archived for a certain time then deleted1 Deleted2 Others6 Don’t know

» how many serialized items do you already store in a repository each year?


4 Up to one million2 1-5 million1 5-10 million3 10-50 million2 More than 50 million17 Don’t know

» what’s your forecast of serialized items to store in a repository once you reach global coverage?


1 Up to one million0 1-5 million1 5-10 million3 10-50 million8 More than 50 million16 Don’t know

237

» how many event messages are generated over an items lifecycle in average by today? (e.g. produced, shipped, stored, etc.)


1 Only one3 1-33 3-52 5-101 More than 1019 Don’t know

» how many event messages will be generated over an items lifecycle in average in future? (e.g. produced, shipped, stored, etc.)


0 Only one4 1-31 3-54 5-102 More than 1018 Don’t know

238 Appendix

4. standards

» how familiar are you with ePc global/gs1 and standards like ePc & ePcis?


3 Never heard of it8 Heard of it, but don’t know what it means11 I know what it is all about4 We actively use these standards4 I/we are actively engaged in EPC Global working groups

» how important is it for your organization to follow ePc global/gs1 standards in the area of Track & Trace?


2 Not important3 Preferred but not necessary7 Must have requirement4 In general we follow EPC Global standards, but will have slightly changes due

to industry requirements4 We have to follow industry specific standards9 Don’t know

» If you have industry specific standards differing from EPC Global/GS1 standards can you please shortly summarize?

3 x own standard, based on GS1

239

5. software & service Provider

» Please select the top criteria for your organization to select a software provider for a global Track & Trace repository.


were possible)

Answers

24 Industry experience14 Standard solution25 Track & Trace expertize11 References6 Recommendation by peers9 Maturity of solution15 Scalability of solution18 Compatible with standards, e.g. EPC Global/GS11 Partner ecosystem4 Length of time in business2 Size/Capital of company8 Offering of consulting services3 Others (please explain): 2 x SAP, 1 x Cost

» Please select the top criteria for your organization to select a service provider to help you in implementing a global repository and defining related business processes.


were possible)

Answers

24 Industry experience25 Track & Trace expertize15 References

240 Appendix

5 Recommendation by peers5 Length of time in business3 Size/Capital of company3 Offering of training services8 Offering of complementary products for Track & Trace4 Others (please explain): SAP Knowledge, Cost, Vista, MDS Logistics PLC

6. budget

» what is your organization‘s approximate 2011 budget for item serialization/Track & Trace?


2 Lower than 100.000 €2 100.000 – 200.000 €1 200.000 – 500.000 €1 500.000 – 1.000.000 €4 1-3 million €3 More than 3 million €0 We have not budget for serialization/Track & Trace16 Don’t know

» how has your organization‘s 2011 Track & Trace budget changed from the 2010 budget?


7 Same budget0 Decreased9 Increased13 Don’t know

241

» how will your organization‘s 2012 Track & Trace budget change from the 2011 budget?


5 Same budget1 Decreased9 Increased14 Don’t know

» by when do you think you will reach roi on your investments for serialization/Track & Trace?


2 Less than one year2 1-2 years8 3-5 years2 5-7 years0 8-10 years0 More than 10 years1 Never14 Don’t know

242 Appendix

7. software

» if you already have Track & Trace in place or plan to have did you or do you plan to separate the topic of serialization at production lines from the tracking and tracing of the items in the supply chain?


10 No, we handle this as one topic8 Yes, we see this as separate topics, but the same team will handle it1 Yes, we see this as separate topics and will have different teams handle these

topics, e.g. different RFP’s and projects10 Don’t know

» do you have already serialization technology at your production lines?


3 No we haven’t and don’t plan to have2 No we haven’t but plan this for the future3 Yes we are already fully equipped9 So far less than 10% of all production lines0 So far less than 20% of all production lines0 So far less than 30% of all production lines0 So far less than 50% of all production lines0 So far less than 80% of all production lines11 Don’t know

243

» do you already have an ePcis repository in place (e.g. saP oer)?


1 No we haven’t and don’t plan to have5 No we haven’t but plan this for the future4 We currently evaluate a global repository6 Yes we are already have one13 Don’t know

» do you have or plan to have local/regional consolidation software for serialized information (e.g. saP aii)?


2 No we haven’t and don’t plan to have3 No we haven’t but plan this for the future4 We currently evaluate a consolidation system5 Yes we are already have one15 Don’t know

» do you have or plan to have a mobile application for capturing event information along the supply chain?


0 No we haven’t and don’t plan to have4 No we haven’t but plan this for the future7 We currently evaluate a mobile application3 We will use the provided SAP tools for this4 Yes we are already have one11 Don’t know

244 Appendix

» how important is it for your organization to integrate event information from the external supply chain in your repository?


2 No need for this6 Nice to have, but not necessary6 Is or will be a requirement in a RFP5 Must have10 Don’t know

» how important is it for your organization to have an easy to use and easy to integrate mobile application for event capturing along the supply chain?


2 No need for this7 Nice to have, but not necessary4 Was, is or will be a requirement in a RFP5 Must have11 Don’t know

» how important is it for your organization that the mobile application offers out of the box features for Track & Trace?


0 No need for this9 Nice to have, but not necessary4 Is or will be a requirement in a RFP2 Must have14 Don’t know

245

8. Project

» Please identify the three most important topics in a Track & Trace project to handle with.


were possible)

Answers

10 Managing labels11 Data volumes and archiving10 Process design9 Serial number range management8 System architecture10 Master data management5 Attributes of serialized items12 Interfaces4 Alerting6 Role & authorization concepts1 Don’t know0 Others

» what do you think is the most important to succeed with a global Track & Trace project?


were possible)

Answers

11 Starting with a detailed/global blueprint (assumed involvement of all stakehol-

ders is given)17 Having necessary involvement by all stakeholders during build phase14 That implementation is done by someone with experience in the area of

Track & Trace2 Don’t know0 Others

246 Appendix

4 Track & Trace survey - dynamic results

This chapter will give an interpretation of the results. Individual answers will not be commented on. Please

refer to Appendix 3. to get a complete overview of all answers. 100% is always based on the complete answers

received (29). If the sum of percentages for some questions don’t reach 100%, the rest are minorities or “don’t

know” answers.

company and Person

The insight gained from the survey is that the majority of the companies, which answered the survey, are glo-

bal players. This is an assumption based on the revenues and number of employees. While the lowest annual

revenue is “just” 10 Million € and the smallest company has just 10 employees and/or 1 plant the biggest num-

bers are 60 Billion € annual revenue, 137.000 employees and/or 500 plants. Taking an average of all answers,

the sample company has a revenue of 8.821 Billion € with 36.161 employees and 81.3 plants.

As expected, most of the companies (48%) answering the survey are from the pharmaceutical/health/medical

sector. This fits perfectly with the high number of companies (65%) stating that compliance with government

mandates and legislations is the main driver for the implementation of Track & Trace.

item serialization/Track & Trace in general

Another indication that legislation is the driver is that; 17% answered that they have been involved in Track

and Trace for 3-5 years and 31% answered that they had been involved in Track & Trace for more than 5 years.

As Track & Trace as a concept is quite new most of the corporations taking care of it do it because they are

forced to do so.

The most important area within a company to start Track & Trace implementation is the production/manu-

facturing according to 72% positive answers. This is somewhat predictable, as this is where products have to

247

be serialized. This also explains the fact that 76% of the companies already do or plan to serialize on item

level. The next most important area where the companies aim to implement serialization or already have, are

warehouses and/or distribution centers, which were both chosen by 51% of those who responded.

50% of participants stated that they are affected by counterfeiters and 50% aren’t. This is an indicator that

anti-counterfeiting measures are not the strongest argument for implementing Track & Trace.

A very positive outcome of the survey is that the importance of Track & Trace has already reached the board

level at 72% of the companies participating. Furthermore, the board is aware of the importance, meanings and

outcome or at least supports the Track & Trace initiatives and projects within their companies.

use of Track & Trace data

While 24% stated that they are already obliged to share their serialized information with authorities and 34%

stated that they will share due to legislations, 21% use the serialized information for internal purposes only.

17% already share captured data with supply chain partners and 28% plan to do so. While the first part is dri-

ven by legislations, the sharing data with supply chain partners seems to be more for optimization reasons in

the supply chain and shorter ROI. It is also for this reason that most of the answers (34%) to the next question

were that the Track & Trace data is integrated in existing software applications due to automatic triggering of

logistic transactions such as e.g. goods issue posting.

Regarding the duration of data storage in the active database and what will happen with the data after a cer-

tain time, the following answers were received; the majority (24%) hold the serialized information for 2-5 years

in the active database. 21% 5-10 years and 10% even more than 10 years. After the data is removed from the

active database 69% will archive it. 21% delete it from the archive after a certain time and 3% will delete the

data directly from the active database.

248 Appendix

For the next block of questions mostly “don’t know” answers were received. So perhaps less value can be

placed on the answers received.

When addressing the present status 14% of the companies currently store up to one million ID’s in their repo-

sitory. This is the majority bearing in mind that 58% answered, “don’t know”. 10% already have between 10-

50 million ID’s per year and 7% even more than 50 million ID’s per year. The average of event messages (e.g.

produced, shipped, received, etc.) per ID is between 3-5 but, 66% gave a “don’t know” answer.

From the response to the question on future forecasts we learn that the majority of companies (28%) will have

more than 50 million ID’s per year. Only 10% 10-50 million ID’s per year and 55% again “don’t know”. The rest

are minorities. Response to the question on forecasts for event messages per ID does not necessarily shows

an increase in line with the increase in the number of ID’s. This can lead to the conclusion that processes and

event messages are mostly in place, but not all production lines are included or equipped with the technology

needed to serialize on an item level.

standards

Only 10% of companies that responded had never heard of EPC Global and the related standards such as EPC

and EPCIS. 27% had heard of it, but did not know the background or origins.

The remainder knew all about it and already uses the standards or is even involved in working groups of EPC

Global/GS1. The reason for the majority knowing about the standards is answered by the next question, which

shows that 24% are required to have them. Only 7% said that the EPC Global standards are not important and

14% said that they have to follow industry specific standards. The rest of the companies either use EPC Global

standards or follow them with slight changes.

249

software & service Provider

The organizations were also asked for their top criteria to select a software and service provider for the

Track & Trace software and the implementation project.

Top 3 criteria for the selection of Track & Trace Software

86% - Track & Trace Experience

83% - Industry Experience

62% - Compatible with standards, e.g. EPC Global

Top 3 criteria for the selection of a service provider

86% - Track & Trace Experience

83% - Industry Experience

52% - References

It is interesting that in both categories Track & Trace experience is the most important criteria directly followed

by industry experience. Experience in the implementation of projects also shows that it is very important to

know what the essential topics are for a Track & Trace project to save valuable time during the business blue-

print and design phase of such a project. Track & Trace projects are in nearly all cases global projects hence,

getting involvement of all necessary stakeholders from the beginning is crucial and therefore, taking up as

little of their time as possible too.

250 Appendix

budget

Analyzing the answers to the questions around the budget for Track & Trace projects, again a high number of

“don’t know” answers were received. Taking the positive answers into consideration, in 2011 14% of all com-

panies had a budget of between 1-3 million €. 13% had less than 1 million € and 10% more than 3 million €

for 2011. It is interesting to see that from 2010 to 2011 the budget stayed the same for all companies (24%)

or increased (31%). None of the companies had a decreasing budget from 2010 to 2011. The same trait can

be seen for 2011 to 2012. 17% will have the same budget, while 31% will have a budget increase. Only one

company gave the answer that the 2011 to 2012 budget will decrease. This leads to the conclusion that for

those in the Track & Trace business the market is only just beginning.

It is also clear for all, that Track & Trace is a very legislation driven topic. Investments are very high and there-

fore ROI times are longer than in “regular” IT projects. Therefore, it is a surprise to see that the majority of

companies (28%) answered that they will reach ROI within 3-5 years (48% don’t know). 14% even said ROI

would be reached in less than 2 years. Only 1 company gave the answer that they never will reach a ROI. With

the majority stating that ROI will be reached in less than 5 years, this has to lead to the conclusion that the

serialized information and the transparency gained will be used extensively for supply chain optimization and

not only to comply with legislations.

software

The first point to address in the software related questions was whether the organizations separate the more

technical related topic of serialization from the more process related topic of tracking and tracing of items. The

spread of answers were quite equal. 34% will handle both topics in one and 31% will handle them as different

topics. However, 31% of those who stated they would handle the two topics separately will do so with the same

team of people, except for one company.

251

As indicated by the questions around number of ID’s stored in the active database, only a small number of

production lines are already equipped with the serialization technologies. 31% have less than 10% of all pro-

duction lines equipped so far. 10% said that they are already fully equipped on all lines. The remainder res-

ponded that they “don’t know” or don’t plan to equip any lines. The last ones are surely the service providers

answering the survey.

Concerning the existence of the most important software applications, the following answers were received.

ePcis/global repository

21% - already have an EPCIS

repository in place

14% - currently evaluating an

EPCIS repository

17% - plan to implement an

EPCIS repository in future

3% - don’t plan to have one

45% - don’t know

consolidation software/edge

server

17% - already have consolidation

software in place

14% - currently evaluate

consolidation software

10% - plan to implement

consolidation software

in future

7% - don’t plan to have one

52% - don’t know

mobile application

(event capturing)

14% - already have a mobile

application in place

24% - currently evaluate a mobile

application

10% - will use the provided

SAP tools

14% - plan to implement a

mobile application in

future

38% - don’t know

252 Appendix

Project

The last chapter includes 2 questions on typical Track & Trace project. First was the question of the three most

important topics in a Track & Trace project.

The most widely chosen answer was interfaces with 41%, closely followed by data volumes and archiving

(38%). In third place there were 3 topics with 34% each. These topics are; managing labels, process design and

master data management.

The last question of the survey was; what is most important for success in a global Track & Trace project. The

answer was the involvement of all stakeholders during the build phase, which is an opinion wholly endorsed

by the author. There are a number of examples of projects stagnating due to the lack of involvement of key

stakeholders. It is essential that companies get all necessary people involved and of course, that all of these

people have shared opinions on processes and how implementation should proceed.

Printed and bounded in Germany 2012

ISBN 978-3-00-039041-8

track trace with sap solutions sh

Documents

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