sap auto-id solutions preventing pharmaceutical diversions and counterfeiting

© 2011 SAP AG. All rights reserved. 1

SAP Auto-ID Solutions Preventing pharmaceutical diversions and counterfeiting

Stephen Cloughley, Sr. Director, SAP Labs LLC

Traceability history & credentials


RFID evolution

SAP engagement

Genesis: 1998-2003

First software company to participate in MIT Auto-ID Center, spawning EPCglobal

Claus Heinrich, SAP Executive Board, authored the book “RFID and Beyond…”

METRO Group Future Store: 2003 Wall Street Journal European Innovations Award

Early years: 2004-2005

Prototype from SAP becomes SAP Auto-ID Infrastructure (SAP AII)

– capture of serialized data from devices at local sites

– provide the business context to turn the data into meaningful business events

– Visionary adoption: Purdue Pharma, Annin, World Kitchen, Pacific Cycle, Kimberly-Clark

Accelerating innovation: 2006-2007

Wide adoption for pharmaceutical anti-counterfeiting mandates (California and beyond)

GS1 EPCIS compliance

Broader value proposition: Pratt & Whitney; Airbus; Biomet, Jena, Daimler….


RFID evolution

SAP engagement

Today and tomorrow

Food Safety Modernization Act – driving adoption in food & beverage

Anti-counterfeiting – SAP AII platform in China, India, Brazil, Turkey….

Alignment with new value proposition in retail

– Focus moved from logistics to item tagging for in-store improvement (VICS, WalMart, U Arkansas

data)

SAP Future Retailing Center (Regensdorf)

Pharmaceutical mandate


Pedigree: “means a record, in electronic form containing information regarding each transaction resulting in a change of ownership of a given

dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering or dispensing the

dangerous drugs. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all

stages of distribution.” (California Business and Professions Code section 4034(a)).

The electronic pedigree must contain specific information

required by statute, and must be made and passed in an “interoperable electronic system,” an electronic track and trace system based on unique

identification numbers (serialization) affixed at the point of manufacture.

Pedigree requirement: Prescription drugs/devices; Veterinary drugs; Hospitals; Samples; Injectables; Generics; Biologics; Radiology

California ePedigree Board of Pharmacy

SAP solution platform


SAP Solution for Auto-ID and item serialization

Content

Decision

Events

Tailored Information

Things

Generated

Content

Execution

Interaction

AII AII AII EmbeddedEmbedded

DM DM DM

Situational

Insight

Automated

Action

AutoID–Enabled Process Automation: SAP AII (Auto-ID Infrastructure) verifies and translates auto-ID raw events received

from device controllers against business requirements in online shop-floor environments . SAP AII automates ERP backend

processes and notifies EPCIS events to SAP OER.

SAP AII Domain =

Business Processes

Automation with Auto-

ID Data Capture

Item serialized lifecycle traceability: SAP OER (object event repository) is a central, intra- and inter-enterprise repository for

serialized item lifecycle information with in-built event management capabilities . SAP OER can record item product/ part

related lifecycle data from distributed business, Auto-ID and sensor systems. SAP OER can be configured to report exceptions

from business requirements and trigger actions such as workflow or messages. As an EPCIS repository it can be queried by

external systems.

SAP OER Domain =

Corporate lifecycle

event management

enabled traceability

repository for

uniquely identified

product/ parts/ assets


监管码印刷规范 SFDA

Country Reporting

Process business events

■Build hierarchical relations

■Link objects to delivery documents

Data content

• Product Code

• Serial-number

• Lot-number

• Expiry-date

Data carrier

Serialization at packaging line

Create unique „license plate‟ for

each saleable unit.

Pick / Pack / Ship Goods issue

Tracking & Tracing throughout entire Supply Chain

Capture each action that is performed against a product items /

case / pallet.

Product Verification

Ensure product authenticity (at point

of dispense or any other supply

chain entity)

Traceability to

the patient in

the hospital


Delivery

System integration services: value generation with RFID

Physics and device expertise

Readers Process integration

Enterprise applications

SAP ERP

SAP OER Capture

interface

Edge execution

Read, write, and transmit data to systems

Manage multiple readers

Cleanse data

Operator workflow

Translate raw data to business execution

Enrich core functions with auto-ID data

Decision support and execute transactions

Function

Device management

SAP ITS mobile Legacy

Query

interfaces

Pa

rtne

r D

evic

e

Ma

na

ge

ment

So

lutio

n

Solution Landscape


Quick Facts: SAP Auto-ID Infrastructure

Functional Domain

• SAP business process execution with serialization in warehouse or production/packaging environment

• Receives business document requirements (e.g. delivery requirements) and translates Auto-ID data capture events into the business context for

automated business document update in ERP including business document requirement verification at source of data capture

Integrates with SAP ERP for Business Process Automation, SAP Object Event Repository for item lifecycle & process tracking a and SAP Partner Device

Management Solutions

• Supports RFID, 2-D and linear barcode

• Supports iUID (UII), EPC and custom unique identifier schemes

• Translates Auto-ID raw events into the business context from ERP business process automation

• Updates SAP OER with Auto-ID events captured

• Enriches ERP ASN with Unique ID lists

Core Function


SAP Auto-ID Infrastructure: Translating raw Auto-ID

events into business context

Key Features

Mapping and rules

processing Activities that

match business

requirements

Routing engine

Prepackaged,

configurable support for

business process

automation

Local data persistence

Auto-ID Raw Events Business Processes

Repository

Translation

Logic


SAP Auto-ID Infrastructure: Translating raw Auto-ID

events into business context

Auto-ID Raw Events Business Processes

Repository

Translation

Logic


AII Cockpit Search Functions

Search

By Document

By Object

By Action (Observation)



Search

By Document

By Object



SAP Object Event Repository features SAP Event Management as a software component

VISIBILITY CONTROL

Empowered by the extensive tracking

& tracing functionalities of built-in SAP

Event Management, SAP OER offers

process monitoring, automated

exception resolution mechanisms,

proactive alerting as well as extensive

reporting capabilities in one single

solution

SAP OER is the global instance

providing visibility on processes,

assets as well as performance along

your entire supply chain.

Extract relevant process

information from globally distributed

systems & partners into one central

repository.

Suppliers

Subcontractors

Retailers 3 PLs

Non-SAP

system

monitor adjust analyze notify


You can view OER data from different perspectives…

Supply Chain Views

As-Built

Configuration

View

Lif

ecycle

„C

urr

en

t“

Co

nfi

gu

rati

on

Vie

w


In OER you can run concurrently multiple tracking/

visibility scenarios

KEY POINT: Here you can select different

views – i.e. tracking scenarios affording

different views on the repository


SAP OER Item / UII Lifecycle Tracking

High Resolution Traceability & Situational Insight

on

tracked items via freely

configurable selection

profile

to

actual status of serialized

products all across the

globe

– SAP OER stores each transaction

that is performed for serialized products and serves as the global system of

record.


-

SAP OER stores

hierarchies between

objects along their

entire lifecycle

SAP OER Item / UII lifecycle Tracking

High Resolution Traceability & Situational Insight


ID Tracking in OER WebUI Selection and Search Results

EPCs encoded on RFID Tag

Ids encoded on 2-D Barcode


Extensibility of SAP OER towards item part lifecycle traceability and

custom EPCIS clients

t

ERP ERP ERP

SAP MII

or

MES

3rd P ERP 3rd P

Embedded

SYS/

sensors SAP AII

condition events events Relevant Doc References

Relevant Attributes & updates

Links to source systems

Doc References

Attributes & updates

Transaction Links

Doc References

Attributes & updates

Transaction Links

Use Standard

Capture

Interface

Current location of product or

asset instances Cross-system configuration

hierarchy tracking Supply Chain Events

Product

Information

Services

*OER = Object Event Repository

Leverage of EPCIS query services

Leverage of EPCIS event capture

notification

GPS

Regulatory reporting with SAP OER


Regulatory Reporting with SAP OER Solution architecture

SAP OER

Receiver 1 (ITS

turkey)

Receiver 2 (PTS

turkey)

Receiver 3 (SFDA China)

Generic Notification

SAP PI

Any receiver

ITS msg Any format PTS msg SFDA msg

AII CMO 3rd party DC

EPCIS event

Regulatory Reporting

Flexible configuration engine

Automatic creation & transfer of notifications

Central UI for visibility & control


Regulatory reporting with SAP OER Functional overview

Flexible configuration of notification types

Multiple notification types, configurable. Maintain:

Process flow for each notification type (direct transmission / wait for batch release / wait for user approval)

Notification characteristics for each notification type (Items only vs. hierarchies)

Generic & future-proof message dispatching

SAP PI acts as dispatching

engine, forwarding notifications to the configured endpoint

PI contains country-specific message mappings, transforming generic notifications sent from OER into the target format

Flexible framework: easily incorporate new receivers

Automatic creation of notifications

Upon receipt of an EPCIS event, OER creates required notifications automatically

Depending on configured process flow, OER directly transmits notifications or wait for further process milestones


Regulatory Reporting with SAP OER Functional overview

Central UI

Central source of information for global regulatory reporting

Selection screen offers personalized & flexible queries on notification data

Process control & exception handling

Control reporting process:

Approve notifications, retrigger notifications

Automated alerting in case of failing notifications

Automatic retriggering of failed notifications

Full visibility into communication

All process steps are shown via event-based view

Access the full message exchange (requests & responses) with the ministries directly from the UI


Sample Screen Notification detail view

Event history & message access


Notification detail view Event history & Message access


OER Notification view Central UI for notification visibility & control

New capability global batch traceability


SAP Global Batch Traceability

Problems solved:

• Querying of batch/lot data

• Relationship of lots/batches (bottom up and top down)

• Quantity accounting (material balance): what product(s)

went to what customer(s) at what address(es)?

• Applies to serialized and non-serialized product


How does batch traceability relates to serialized item

tracking?

SAP Global Batch Traceability SAP OER/ SAP Auto-ID

Infrastructure

Answers how a product was created

Which batches of which materials went into each step of

a product creation (product genealogy or batch network)

Which instance serialized numbers were created for a

finished product

Answers what lifecycle events happened to an

instance of a finished from birth to disposal/

consumption

Item serialized product event traceability

create product item lifecycle event line (track and

traceability)

Answers the distribution of the remaining quantities of

batches used in the production

What other tracked objects can we consider:

Handling units

Serial Number List

Purchase Orders

Deliveries

How a product came to be Records what happens during a product life


SAP Traceability Strategy

Enable End-to-end Traceability of products, parts and assets - from

raw material to point of consumption

Product Genealogy Product, part & asset lifecycle traceability

Life of a product item:

What events happen to a product item Product ancestry:

How a product item came to be

SAP Global Batch Traceability SAP Object Event Repository

New

Batch ID

Item serialized

product instance


Selection of serialization customers (partial)

http://www.bitc.unh.edu/Member_Page_New/BoehringerLogo(pantone288).jpg


Please visit our dedicated Auto-ID Website at:

http://www.sap.com/RFID

http://www.sap.com/RFID


Where to find more functional information

For Solution & Functional Details – kindly visit us @

http://help.sap.com/aii

and

http://help.sap.com/saphelp_aii710/helpdata/de/48/bdf013bb660611e10000000a42189

b/frameset.htm

http://help.sap.com/aii

http://help.sap.com/saphelp_aii710/helpdata/de/48/bdf013bb660611e10000000a42189b/frameset.htm

http://help.sap.com/saphelp_aii710/helpdata/de/48/bdf013bb660611e10000000a42189b/frameset.htm

Thank you!

Stephen Cloughley

Sr. Director

Auto-ID & Supply Network Traceability

SAP Labs, LLC

3999 West Chester Pike

Newtown Square PA, USA

Office +1 610 661-1000

Mobile +1 267 312-0326

[email protected]

www.sap.com

mailto:[email protected]

http://www.sap.com/

sap auto-id solutions preventing pharmaceutical diversions and counterfeiting

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