Serialization Framework White Paper

Executive Summary

No other company has as much experience in the delivery of SAP Serialization and Track & Trace solutions than Movilitas Consulting. Our experience encompasses the pharmaceutical industry, where we have delivered to 8 of the top 15 Pharmaceutical companies globally, as well as in the tobacco, mining and agro-chemical industries. We have used this unrivalled experience to develop a series of carefully crafted consultancy packages to enable you to meet the challenge and deliver your own Serialization programm effectively and successfully. These packages use our own Proven Movilitas Processes and are complimented by a growing portfolio of design accelerators, repeatable implementations and services. Or if you wish, we can take responsibility for and deliver our own Best Practise Serialization solutions, managed by our own project managers using our own project management approach.

Serialization program are complex and fluid. The regulatory landscape is by no means static, nor is it expected to remain so. Any organization selling products into these regulated markets can expect that the requirements will continue to evolve over a 10+ year time frame. Serialization is not a one-off development.

Selecting the right partner for this journey is key.

Movilitas has the experience to assist you and the expertise to help you develop the right solutions.

Taking the long term view

Movilitas Consulting strongly believes that organizations should take the long term view and plan accordingly. This begins by understanding the pervasive impact of a serialization program upon an organization, understanding that you will have to bring together a diverse group of key stakeholders, understanding that to be successful you will have to build a core team with widely disparate skills and maintain that team over a prolonged period of time.

CommercialGvt relationshipCustomerSupportRisks: fines

EngineeringProcessesTechnologyOEEMES integrationSkills

Supply ChainProcessesCulture changeTechnologyRoutesSkills & Risks

ITERP integrationData MastersBig EPCIS DataTools & Support

LegalLiabilities and riskGvt relationshipLegalinterpretationFine avoidance

LobbyingGS1 StandardsGvt requirementsInterpretations

CorporateReputationMarketingTalent MgtP&L impact

FinanceTCO / ROICost forecastingCAPEX/ OPEXCost of non-compliance

Q & AQuality redefinedSOPs reviewedSkills and Training

ProcurementNew productsNew capabilities

Looking ahead and having a long term vision and plan to use serialization data pro-actively to introduce improvements in the Supply Chain as well as drive out inefficiencies is key to maximizing the benefits from the investments that have to be made to meet the various serialization regulations.

Consider where your organization needs to be in 10 years time; operating within an integrated industry; sending data to various regulatory bodies; exchanging information with external and internal partners, both up-stream and down- stream within the supply chain. Consider how you wish your organization to operate within such an industry and how you might use and leverage the information you receive; the cost of owning and retaining the data; the cost of not supplying maintaining the data accurately and in a timely fashion.Developing a clear roadmap of objectives and a planned program designed to implement those objectives will allow your organization to understand what the costs are and when the benefits can be realized. Conversely, if there is no roadmap, the costs of serialization are often viewed simply as an overhead that can deliver no real benefit, and that is a lost opportunity.

Pilot Market

BasicEvents

GTINCentralised

BasicRepack

AdvancedEvents

AdvancedRepack

DataReconciliati

on

Full BatchShipping

SouthKorea

Brazil

Archiving Variable SNLength

PartialShipment

EventsBusiness

Logic

WarehouseRepack

CentralLabelling

Serial.Support

Chinaautomated

Serial.Returns

O2CIntegration

TargetedRecalls

Serial.Inventory

CMOs Licensees

EFPIAEMVS

release 1 release 2 release 4release 3

End-state

Backward Scoping

Maturity

Complexity

release x

Consulting Packages

Our consulting packages are specifically designed to meet the needs of the individual phases of a typical serialization program or can be taken in sequence to deliver a complete Movilitas Best Practise Serialization solution.

PMP 1 Induction PMP 3 Requirements & Processes PMP 4 Design PMP 5 Implement

PMP 9 Archiving Implementation

Repeatable ImplementationsRandomization

China SN Management,Lean Track & Trace (Movilizer)

Reconciliation & LogisticsMobile Apps for Track & Trace

EPCIS Repository Migration

PMP 2 Proof of Concept

PMP 11 Warehouse Integration

PMP 12 Technology Training

Support Services

build, test,deploy

GatherRequirements

Briefing &preparation

defineprocesses

design &blueprint

service &support

project management approach

PMP 10 Performance Testing

Movilitas Framework for Track & Trace

PMP 6 Our standard implementation of Serialization, delivering a scalable solution and typically consisting of PMP 1, PMP 3, PMP 4 and PMP 5 (other options can be added)

PMP 7 Our standard implementation of Serialization, expanded to include Supply Chain integration (with or without PMP 11), using the Movilizer Mobile solution for Track & Trace

Our PMP 1 package, Serialization Induction, is specifically designed to deliver:

• A comprehensive briefing on the challenges that Serialization programs face • The guidance needed to plan and deliver a successful Serialization program• An up-to-date awareness of the key regulatory requirements & milestones• A thorough understanding of the SAP Serialization solutions

PMP 3, Requirements and Processes, is a solution agnostic consultancy package designed to follow on from PMP 1 and which aims to capture and document the key requirements associated with a serialization program. A detailed analysis of the “as is” processes is followed by the development of a “to be” process model. Central to this approach is the necessity to define, document and agree a clear vision for the future phases of the Serialization program. In addition we define a requirements trace matrix which is carried through the design cycle(s) into the build and test phases of the program and we provide a core set of foundation requirements which can be used as a baseline for serialization projects.

PMP 4, Design, delivers the solution architecture as well as the detailed functional blueprints for an SAP solution using SAP OER and optionally SAP AII and possibly the SAP RCS Solution for Regulatory Reporting. Where appropriate the design solution will incorporate Movilitas repeatable implementations and design accelerators. Movilitas will deliver a SAP solution architecture that matches and fits to the overall end-end solution architecture; typically this involves working with the line/site solution suppliers, warehousing & distribution system suppliers as well as internal technical teams and stakeholders. Longer term, a comprehensive solution may need to be capable of.

• Delivering information to market regulators• Exchanging information with CMO’s • Accepting and receiving data from supply chain partners• Integrating and operating with mobile platforms

In PMP 5, Implement, Movilitas functional consultants and developers take the designs and blueprints and then build, unit test and conduct the informal and formal systems integration testing. Configuration of the SAP products SAP OER and SAP PI is a fundamental element of this package and we are also able to configure SAP AII if it is in scope. Movilitas is able to provide standard test scenarios for our foundation requirements; these can be used if Movilitas were responsible for the URS production. User acceptance testing (or OQ Testing as it is sometimes referred to) is outside the scope of PMP 5.

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We can set up and manage a series of standard performance tests (PMP 10) to assist benchmarking your infrastructure and the capacity and throughput of your end-to-end solutions.

And where Warehousing solutions are required, we can supplement our existing packages with PMP 11, Warehouse Integration.

In addition to our consulting packages, we offer repeatable implementations and services; these can deliver you fast effective solutions, cutting down your implementation times and your costs.

Repeatable Implementations

• Randomization

• China Serial Number Management

• Reconciliation & Logistics Label Printing

• Lean Track & Trace

• Mobile Apps for Track & Trace

• EPCIS Repository Migration

PMP 6 is the Movilitas standard implementation of a Core Serialization capability using SAP technology; essentially the bundling of PMP 1, PMP 3, PMP 4, PMP 5 together with Movilitas taking responsibility for full project management of the packages. Where an integrated Supply Chain solution is required or indicated PMP 7 is our recommended implementation package and uses the Movilizer Mobile solution, the state of the art mobile application platform when it comes to mobilize your Track & Trace processes.These key consulting packages are supplemented by a number of specialist packages; for example we can build you a proof of concept system (PMP 2) to assist in selecting appropriate line and site solutions.

We offer an archiving solution (PMP 9) based around the OpenText model and which can be customized to your organizations needs.

SAP OER

SARA Transaction (Archiving customizing)

Scheduling of deactivation,flagging, writing anddeletion jobs

Archiving InformationSystem (AIS)

Enterprise Archiving

(Opentext)

Package 1: Definition of overall archivingstrategy (including workshops)

Package 2: System customizing in SAP OER(Transaction SARA and other related EHsettings, including AIS)

Package 3: Configuration of EnterpriseArchiving Server

Package 4: Configuration of archiving jobsand dependencies

Package 5: Tests runs and go Live support

Services

• 2nd Level Support

Our unique combination of consultancy packages, products and services gives our customers a highly flexible range of choices from which they can mix and match to suit their needs, knowing that all of our offerings are proven and developed to our best practices.

About Movilitas Consulting

Movilitas Consulting, an SAP software and services partner, provides end-to-end SAP Supply Chain, Track & Trace and Mobility Solutions. Movilitas Consulting solutions enhance customers’ control of their extended supply chain, ensure compliance with global regulations and optimize field-based business processes helping to accelerate the pace of business performance.

Contact usContact us

Movilitas Consulting NA10330 Old Columbia Rd. Columbia, MD 20146 Phone: 800-359-1712Email: info.na@movilitas.com

Movilitas Consulting EUJulius- Hatry- Straße 1 68163 Mannheim Phone: +49 6211502040Email: sales@movilitas.com

EUROPE

north america