simatic IT

Simatic IT UnilabEffective quality assurance – LIMS

UNILAB

Optimize the workflowthroughout the company

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It’s becoming increasingly important for enterprises to coordinate the business

and production processes in order to optimize the benefit of the value-added

chain – for the entire company and for individual plants. Today, the challenge

is minimizing the total cost of global operation while improving the flexibility.

Gapless communication with MES

Manufacturing Execution Systems (MES)

close the information gaps between the man-

agement processes at the ERP level and the

production processes and plants at the auto-

mation level. Siemens has developed a revolu-

tionary MES solution based on current and

future market requirements: Simatic IT.

Simatic IT builds the bridge between ERP

and process control

With Simatic IT, you can coordinate all your

business and production processes – within

individual production facilities as well as in

the entire company and in the supply chain.

In this way, you can preserve the value of

earlier IT investments. The MES solution is

based on the ISA S95 standard, focusing on

different functionalities, processes and work-

flows – factors that substantially determine

the success of businesses. Simatic IT consists

of a Framework (Modeling) and Components

(providing specific functionality). An example

for specific functionality is LIMS (Laboratory

Information Management System) for quality

assurance. Simatic IT Unilab provides this

functionality, either as a stand-alone solution

or as part of the Simatic IT MES concept.

Part of Totally Integrated Automation

As an integral part of Totally Integrated Auto-

mation (TIA), the most comprehensive solution

platform from Siemens, Simatic IT enables

you to coordinate and harmonize business

and production processes optimally – horizon-

tally and vertically. TIA is open to new tech-

nologies, new tools and partners – not only

in automation technology, but also beyond in

the communication network of the IT world.

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If companies want to successfully manage the

huge quantities of quality-related data from

a wide variety of different sources, they require

quality assurance systems that support the

entire business process – that is, global LIMS

(Laboratory Information Management System)

solutions.

LIMS at its best – Simatic IT Unilab

Whether as a stand-alone version or as an

integrated part of Simatic IT, Simatic IT Unilab

is now one of the world’s leading LIMS solu-

tions – with a top position in the process

industry. One important reason for this leading

LIMS position: Simatic IT Unilab is justifiably

regarded as by far the most reliable LIMS solu-

tion and wins supporters with its 100-percent

success rate upon implementation. Therefore

a large number of multinational companies

in process industries use the system developed

in 1989 as independent LIMS or as the core

of their quality management system. In addi-

tion, Simatic IT Unilab is being implemented

more and more in the environmental, animal

health and water analysis sectors and various

other industrial environments.

All over the world, laboratories are under enormous pressure to do an ever-

increasing amount of work with fewer employees and at lower cost. This

situation is emphasized by the fact that regulations are becoming more complex

and stringent. QC laboratories need to react faster, R&D laboratories need to

bring new products to the market faster, Service and independant laboratories

need to increase their customer satisfaction to remain competitive.

The answer to more stringent qualityrequirements – LIMS

Number onein quality assurance

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Quality assurance at the least cost

The dedicated lab manager‘s main goal is

quality assurance – followed directly by mini-

mizing costs. This pressure is further intensified

because the lab must meet increasingly strict

regulations (GLP, GAMP, ISO, FDA, etc.). All of

these goals and challenges are however not

necessarily as incompatible as they may seem

at first glance: quality assurance goes beyond

mere customer, environmental and regulatory

compliance. It also includes the proactive use

of all available quality data. The result: im-

proved lab efficiency, overall product conformity

and manufacturing cost efficiency.

Quality is the highest priority at Siemens, too. Simatic IT Unilab, our award-

winning LIMS solution, will meet your highest requirements. Long tested in

practice, it has proven itself time and time again in industry. Today, however,

it also confirms that Siemens is absolutely the industry standard that our

customers and LIMS professionals around the world depend on.

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Simatic IT Unilab’s comprehensive

functionality

With our best-of-breed LIMS solution you can:

Model and manage the complete workflow

of all quality data in the lab and on the

production line: samples, analyses, instru-

ments, reports, and even lab personnel

qualifications

Manage all types of analyses at multiple

sites in multiple languages: raw materials,

intermediate and finished products, envi-

ronmental analyses, competitor analyses,

ring analyses, on-line analyses, off-line anal-

yses, R&D analyses, etc.

Ensure that your laboratory complies with

every major quality standard (such as GLP,

GAMP, ISO 9001:2000, ISO 17025 and

21 CFR Part 11, the FDA ruling on electronic

records and signatures)

Bring the full e-spectrum into your lab with

the Simatic IT Unilab interactive Internet

interface for the exchange of quality data

between the lab and production operators,

warehouse, suppliers, co-manufacturers,

etc.

Economic and effective

Another advantage of Simatic IT Unilab is that

Siemens and our business partners have the

experience and the know-how to support you

in implementing and validating our LIMS so-

lution quickly and easily. This saves you sub-

stantial time and effort. And thanks to the

comprehensive functionality of Simatic IT

Unilab, not only are you able to ensure quality

at least cost, but you can also own it at least

cost because:

Standard templates already fit the vast ma-

jority of your lab requirements – allowing

you a fast and effective implementation.

The exceptionally high configurability and

flexibility of Simatic IT Unilab lets author-

ized users manage product types, methods

of analysis, calculations, workflow, report

layouts, etc. at maximum speed and at mini-

mum cost.

The scalable architecture and licensing struc-

ture allows you to implement only the

functions you need – on a platform already

conforming to tomorrow’s requirements.

Simatic IT Unilab is available as a stand-

alone LIMS or as a part of Simatic IT – but

you are not limited to just Simatic IT soft-

ware, because Simatic IT Unilab is compatible

with almost every standard or home-grown

business or plant system (ERP, MES, etc.)

and turns every LIMS into a quality

management system.

Business benefits

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Streamlining quality management involves to some degree every department

in your organization. These activities must be an integrated part of your

business model. Simatic IT Unilab offers direct, tangible benefits to many

individual departments, but it also creates synergistic advantages for effective

collaboration throughout the entire enterprise – and all parties involved benefit.

For plant managers,

QA managers, lab managers and

supervisors

The lab is simultaneously the source of the

ideas and the controlling organization to keep

the company‘s products and quality competi-

tive. As the manager or supervisor, it is your

task to optimize the efficiency of your lab. To

do this, you absolutely must have correct

information – in a timely manner. Only then

can you make the right decisions at the right

time. And Simatic IT Unilab does exactly that:

• Improving the workflow

Simatic IT Unilab supports your organization

in meeting important legal regulations such

as GLP, GAMP, ISO and FDA. This by managing

your full lab workflow, providing electronic

signatures and an audit trail. These functions

support documentation of the workflow. In

addition, Simatic IT Unilab provides QA/QC

specifications, manages methods and proce-

dures centrally, and has modules for equip-

ment management and qualification manage-

ment. These functions guarantee each analysis

is performed by a trained analyst on a calibrat-

ed instrument.

• Optimizing decision-making

Simatic IT Unilab‘s Management by Exception

function supports you in the decision-making

process. It allows you to focus on the unex-

pected. Clear and concise reports provide exact

status on lab performance and workload

whenever you need it. Bottlenecks in quality

control are all virtually eliminated.

• Shorter process times

Simatic IT Unilab makes shorter process times

possible. The lead time for samples and anal-

ysis can be clearly reduced – for example by

integrating with your standard or home-grown

ERP, MES and other systems. In addition, the

total process time for samples and analyses

can be further optimized – by using barcodes,

instrument connections, Management by

Exception, automatic report generation, and

numerous other functions.

• Improving the customer service

level

Simatic IT Unilab pays off at the customer

service level as well. With our LIMS solution

you can generate certificates of analysis con-

formed to your customer‘s specific needs.

The full e-spectrum of Simatic IT Unilab allows

production operators to submit requests and

investigate analysis results around the clock.

Suppliers and co-manufacturers can also be

included in these processes via the Internet.

For lab analysts

The requirements faced by lab analysts are

greater than ever: they have to do more work,

more accurately – with more sophisticated

equipment and all with fewer staff. Simatic IT

Unilab is the solution.

• Faster data entry

Simatic IT Unilab supports fast data entry of

results because Simatic IT Unilab can automat-

ically generate worklists for various analysts

or departments. The system provides one

screen for all required input, supporting mul-

tiple line entries, default results, instrument

connections and barcode scanners to dramat-

ically speed up this process.

• Fewer entry errors

Whenever possible, Simatic IT Unilab reuses

existing results and equipment constants for

other calculations. This not only saves you

considerable time, but you also avoid repetitive

entries – and thus potential entry errors.

• Many tasks automatically

Simatic IT Unilab allows sample registration

through an interface with production or ware-

house systems – by automating administrative

and repetitive tasks. Reports can be sent au-

tomatically to customers based on the config-

ured workflow.

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Business benefits

For plant operators

and supervisors

Supervisors and plant operators are required

to be more involved with quality. Simatic IT

Unilab also addresses these needs:

• Less scrap and rework

Plant operators and supervisors receive imme-

diate feedback on samples analyzed in the

lab. Scrap and rework are kept to an absolute

minimum.

• Analyses during production

Quality control is currently shifting from lab

analysis on finished products to analysis of

intermediate stages during production. An

important benefit of Simatic IT Unilab is its

support for quality analysis during the process.

For IT personnel

Today‘s IT staff face a bewildering variety

of documents, spreadsheets and systems –

home-grown and other. All these things make

up the typical enterprise LIMS. More often

than not, these are non-standard systems,

resulting in high support costs, limited scala-

bility and difficulties in keeping current with

market technology. Also, it is all but impossible

to integrate them with evolving enterprise

systems. In this case, Simatic IT Unilab is the

right solution.

The system is offered through a network of

Siemens offices and strategic business partners

– all of whom are experts with the relevant

skills and know-how. They provide a complete

range of services, such as training, support,

implementation and validation.

• Standardized and scalable

Simatic IT Unilab has become the industry

standard in hardware and software. The

system is based on industry standards such

as Oracle, Microsoft, NT, and Unix. You can

choose an architecture with two or three tiers.

Simatic IT Unilab is standardized and was

designed to interface with other enterprise

systems (ERP, MES, etc.) through conventional

and emerging technologies (such as XML).

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Simatic IT Unilab has a scalable architecture

and licensing structure. Its flexible architecture

lets you implement just the functions you

really need – on a platform conforming to

your scale and ambitions. With Simatic IT

Unilab you can start small-based on today‘s

needs and grow into whatever possibilities

tomorrow holds for your enterprise.

• Supporting continuous evolution

Simatic IT Unilab supports continuous evolu-

tion. Any authorized user can easily manage

configuration changes and common adminis-

tration – and authorized lab employees can

also add or change product types, methods

of analysis, calculations, workflow, report

layouts, etc., maximizing the flexibility of your

lab and minimizing the ongoing maintenance.

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Designed down to the details –Simatic IT Unilab’s highlights

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Simatic IT Unilab is designed in modular

functions. In this way, you can implement the

individual functions incrementally. It allows

you to easily deploy applications across all of

your enterprise – or just in part.

Intelligent quality assurance

Simatic IT Unilab uses a central database con-

cept with a predefined schema. This means

that information is always stored in the same

structure, independent of your configuration.

This “central quality repository” is relational

and object-oriented with ready-to-use rela-

tionships between study, project, request,

sample, analysis, method of analysis, etc.

A corporate architecture

Whether you opt for the centralized or the

distributed architecture, the multilab concept

of Simatic IT Unilab provides an enterprise-

wide LIMS solution for all QC, service and R&D

labs and guarantees that every lab, depart-

ment and user has a personalized environment

that is tailored perfectly to the respective roles

and needs – with personally selected language

settings, tasks, data, layouts and preferences.

Simatic IT Unilab is available in five languages.

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Figure – Example of a worklist used by Glenn Taylor

Managing all quality data

Simatic IT Unilab provides for the collection

and management of all quality data – from

raw material, intermediate and finished prod-

uct samples through environmental and ring

analyses and trial samples. The system also

includes brand-watching and R&D and stability

studies. Simatic IT Unilab supports this collec-

tion and management of quality data with

matching workflows, screens, tasks, alarms,

etc. to guarantee the correct handling of every

class of quality data.

Simatic IT Unilab offers the total spectrum of

LIMS functions for managing all quality data,

including:

Sample log-in and sample planning

Worklist and worksheet management

Analysis result entry, processing, verifica-

tion and validation

Instrument connections

Equipment and qualification management

Management by Exception and alarm

handling

Full audit trail and electronic signatures

SOP support (standard operational

procedures)

Management by Exception

The Simatic IT Unilab configurable workflow

supports Management by Exception. For ex-

ample, if 99 % of your analysis is within spec-

ifications but 1 % is off spec, this function will

perform 99 % of the validation work. This

leaves the supervisor the time to focus on the

validation of the 1 % that failed to meet spec-

ifications.

Equipment and qualification

management

In regulated environments, specific require-

ments exist for equipments and operators in

order to comply with (international) standards.

The Equipment Management module allows

you to maintain all required information on

each piece of equipment within Simatic IT

Unilab and provides functions for managing

calibration and maintenance rules – including

the required audit trail.

In addition, the Qualification Management

module allows you to track and enforce oper-

ator training/certification.

Designed down to the details –Simatic IT Unilab‘s highlights

Advanced configurability

Simatic IT Unilab is regarded as the most con-

figurable LIMS solution on the market – con-

figurable by authorized end users, not by IT

experts. Siemens emphasizes that authorized

users can make advanced configuration

changes at the ordinary end-user level – in-

cluding administrative changes regarding users,

departments, security, etc.

And the normal lab staff can easily and quickly

make changes in product and sample types,

information fields, specifications, methods of

analysis and calculations, equipment, work-

flows, layouts, reports, etc.

Web-based technology

Simatic IT Unilab is completely Internet-ready.

The web-based client allows users to submit

analysis requests and retrieve, view, and print

any type of information – with complete access

control and security. This function enables

customers to submit analysis requests directly

via the Internet and follow up on a timely

basis for results. This direct customer interac-

tion reduces the number of errors, decreases

administrative workload, and increases cus-

tomer satisfaction. Lab information is available

24/7. The next step is for production operations,

suppliers and manufacturers to submit quality

results in the web.

All web screens are fully configurable and

dynamically generated – based upon the same

configuration rules. These rules also apply to

the modules, which guarantees 100 % consist-

ency between Web and non-Web modules.

Figure – Example of a Web user interface (submitting analysis results)

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Designed down to the details –Simatic IT Unilab‘s highlights

Managing information

As an integral part of Simatic IT, Simatic IT

Unilab comes with a standard flexible reporting

module. This module is based on Business

Objects™, supports basic statistics functions

such as avg, stddev, Cp and Cpk and can be

integrated seamlessly in Microsoft Office™,

Microsoft Word™ and Microsoft Excel™ appli-

cations. Of course, Simatic IT Unilab can also

be integrated with nearly every other applica-

tion such as statisticed packages, reporting

packages and document management systems.

Complying with legal regulations and

21CFR11

Simatic IT Unilab offers full auditing function-

ality supporting compliance with legal regu-

lations and norms and 21CFR11. Since regula-

tory compliance requirements differ from

customer to customer, the system allows the

different levels of auditing functionality to be

switched on/off based on the specific compli-

ancy requirements of the customer.

The following main blocks of auditing func-

tionality can be distinguished:

System security and authority checks:

protection through secure log-in procedure,

tracking of (un)successful log-in attempts,

password expiration, blocking of log-in after

x unsuccessful attempts, autolocking, auto-

closing, etc.

Electronic signatures

History and history details: history logging

of all changes to records including who,

what, when, why, comment, old and new

values, etc.

Record retention and reproducibility: online

and archive database

Version control: version control on objects

such as sample types, parameter profiles

and their specifications, method sheets and

their calculations, etc.

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Stability module

Stability tests are used to determine the extent

to which the quality of a substance varies with

time under the influence of a variety of envi-

ronmental factors such as temperature, humi-

dity, and light. Based on the obtained results,

recommendations can be made regarding

storage conditions, retest periods, and shelf

lives.

Simatic IT Unilab’s stability module supports

Unilab customers in introducing new sub-

stances/ingredients and developing new dos-

age forms.

Hand-held devices

Laboratories working with mobile workforces

now also have the possibility to collect data

in the field, that is, in a sterile environment

or at a remote production line, with a tablet

or pocket PC. Not having to write down raw

data first and then having to enter this raw

data into the LIMS system saves considerable

time and also avoids potential errors.

Cost calculation module

Specifically for independent or commercial

labs, Simatic IT Unilab offers a new cost cal-

culation module. With this module, it is pos-

sible to calculate the cost of an analysis request

arriving at the lab based on price catalogs.

Subsequently, detailed invoice data for this

particular request can be issued to accounting

departments. This automates the process of

invoicing lab customers.

Image as a success factor

Simatic IT Unilab makes a considerable contri-

bution toward a company‘s image. The sys-

tem’s efficiency and technical sophistication

ensures that all legal regulations (FDA, GLP,

GAMP) will be upheld – a protection against

expensive recall campaigns. And that the com-

pany image is not damaged. Because nothing

is as difficult to correct as an image that has

borne damage in the eyes of the target group.

Future investment security included

When a company makes a decision for Simatic

IT Unilab, it makes a decision for continuity

and investment security. Why? Because the

product will continue to be developed in ac-

cordance with market demands, which in-

cludes changes in the work methods (Web

architecture) and compliance with relevant

legal regulations (21CFR Part 11).

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Compelling argumentsat a glance

SiemensCompex IT Plant Solutions N.V.Halsesteenweg 31B-9402 NinoveBelgiumTel.: +32 54 312 610

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Business-related benefits

– Protection of quality

– Shorter lead times for samples and analyses

– Better support for decision-making

– Improvements in customer service

– Fulfillment of legal regulations and specifications

– Support for administrative tasks

– Reduction of errors

– Immediate feedback on the samples analyzed

– Industrial standards for hardware and software

– Open system, enabling interfacing with other systems

– Networking of offices and business partners

– Scalable architecture/license structure

– Standard software module

The full spectrum of LIMS functions for managing all

quality data:

– Sample log-in and samples planning

– Management of worklists and worksheets

– Entry, processing and validation of analysis results

– Instrument connections

– Equipment and qualification management

– Management by exception and alarm processing

– Complete audit trail and electronic signatures

– SOP support (standard operational procedures)

Important technical details

– Unilab architecture with two or three tiers:

database server, Web server and client. Most im-

portant: the API layer (Application User Interface).

It ensures the correct test path and correct function-

related user access.

– LIMS interface to the Intranet/Internet to create reports

or request analyses or to provide samples and results

– using the latest technology (XML) and the strictest

security standards.

– Client: Windows, Citrix, TS, Internet Explorer

– Web server: Windows

– Database server: Windows, Unix

Worldwide competence – directly on site

Simatic IT Unilab is offered through a network of Siemens

offices and strategic business partners, all of whom have

the skills and experience essential to provide the full range

of training, support, implementation and validation assist-

ance.