Our Track & Trace and Serialization Capabilities & Offerings

Serialization regulations have been initiated by the U.S., Canada, Turkey, India, China, Brazil, Argentina and South Korea. While there are some differences among them, each nation’s regulations revolve around putting a unique code on a saleable unit, establishing a reporting mechanism across the supply chain to track its movement and providing a mechanism for verification or authentication. When responding to these emerging regulations, pharmaceutical companies should take a broad perspective instead of focusing on country-specific requirements and design their solutions to leverage components across processes and manufacturing facilities for various countries.

Serialization is not just about generating unique serial numbers but also maintaining those identifications within the supply chain. It requires collaborative action from partners throughout the supply chain for accurate recording, tracking and managing of data as the product moves from manufacturer to the distributor to the dispensing point.

Our Approach & Offerings

Cognizant strongly advocates that pharmaceutical companies look beyond just meeting regulatory requirements while undertaking serialization projects. Though the immediate business priority is regulatory compliance, in our view, serialization

is providing a monumental opportunity for pharmaceutical companies to overhaul their supply chain and consumer-related initiatives. With that in mind, our approach has been to design and implement a serialization solution that is scalable, accessible and open for integration in the future. Our serialization solution addresses the challenges at the shop floor and plant levels and connects to the enterprise level. The solution deploys units of unique identification (“serialization”) and creates associated unit-level electronic records that can be easily accessed via the Web or smartphones in real time. Simple and ubiquitous access to product IDs (or UIDs) and related data provide a previously unavailable level of visibility into the production, distribution and use of products or their components throughout the supply chain.

We strongly recommend pharmaceutical companies undertake an in-depth analysis of their current scenario and consider a multi-phased implementation of serialization that entails:

• Evaluating current systems and processes forproduct serialization by considering multiplefactors such as functionality, technicalelements, interfacing and cost.

• Facilitating discussions on the future statefor serialization and gathering high-levelrequirements.

• Cognizant Solutions Overview

cognizant solutions overview | september 2015

CASE STUDIES >>

• Developing a comprehensive strategy to comply with regulatory requirements and to leverageserialized data information for competitive supply chain advantages.

• Providing consulting services in the areas of business processes, country specific regulatoryrequirements, data standardization (MDM, ERP integration with solution), vendor selection andoverall solution architecture.

• Provided consulting services to evaluate different vendors providing solutions in ePedigree andgovernment reporting and selection of most appropriate vendor based on business requirements.

• Implementation of barcode-based serialization solution (1D/2D barcode label) to comply withTurkey Ministry of Health mandate.

• Implementation support program where we are responsible for interface development, andvalidation and testing efforts for lot-level traceability and verification, warehouse pick to lightreplacement, and internal packaging implementation.

• Implementation of serialization and ePedigree pilot on SAP platform using SAP AII integrated withSAP R/3 and device layer through SAP PI. We also developed and configured software on a mobileplatform to capture bar codes and to communicate with SAP systems.

• Provided consulting services to develop a short and long term strategic track and traceimplementation roadmap.

Pharmaceutical companies and governments of countries worldwide believe that counterfeiting by organized crime can be reduced significantly by implementing product serialization and tracking the product movement across the supply chain. Serialization has a direct impact on your packaging processes, warehousing processes, outbound logistics, returns management and product recall processes.

The opportunity lies in utilizing the product movement data collected across the supply chain to check diversions and frauds and to increase internal and external efficiencies through closer collaboration with supply chain partners. Various consumer-related initiatives also stand to benefit by serialization.

solutions overview 2

wms

Security

Authentication

Authorization

Exception Handling

Audit Trail

Regulatory Compliance

ERP

Serial Number /Code Generation

VerificationAggregation

Product Hierarchy Code Relationship

Split

Event Tracking

Pick & Pack

External SerialNumber

Serial Number Provisioning

Serial NumberManager

Corporate Systems

Cross CuttingComponents

Interfaces

Presentation & Process Layer

Integration Layer

Business Layer Business Components

Traceability Workflow

Central Repository

Web based UI

SOA based integration

Level 0-2

Data Source

3rd Party Integration

Warehouse

MES

CMO

National Authorities

Serialization Solution Architecture

Tangible Benefits Intangible Benefits

• Supply chain visibility

• Minimizing impacts of counterfeit products

• Effective recall and returns mechanism

• Efficient reimbursement and chargeback

programs

• Patient engagement

• Patient safety

• Brand protection

• Enhanced brand value

Benefits of Serialization

Our Offerings & Experience

Consulting Services

IT ServicesIntegration

Services

Regulatory and Business Solution Implementation

Business Process Services

• Program Management

• Business CapabilityAssessment /Diagnostics

• RoadmapPreparation

• VendorAssessment andSelection

• Business ProcessConsulting

• Serialization SolutionImplementation/ ProductConfigurations

• Packaging Line Leveland Site LevelImplementation

• Organization LevelImplementation

• GS1 Compliance

• ERP, WMS,SCM relatedIntegration -SOs, ASNs,

• Cloud Service BureauIntegration(EPCIS), Portals,Data

• Master DataManagement

• Testing and ValidationServices

• ePedigree Generation andSubmissionand otherGovernmentReportingApplications

• SCM Analyticsand PatientEngagementApplications

• Labeling and ArtworkManagement

• RegulatoryDossierUpdating andSubmissionManagement

solutions overview 3

World Headquarters

500 Frank W. Burr Blvd.Teaneck, NJ 07666 USAPhone: +1 201 801 0233Fax: +1 201 801 0243Toll Free: +1 888 937 3277Email: inquiry@cognizant.com

European Headquarters

1 Kingdom StreetPaddington CentralLondon W2 6BDPhone: +44 207 297 7600Fax: +44 207 121 0102Email: infouk@cognizant.com

India Operations Headquarters

#5/535, Old Mahabalipuram RoadOkkiyam Pettai, ThoraipakkamChennai, 600 096 IndiaPhone: +91 (0) 44 4209 6000Fax: +91 (0) 44 4209 6060Email: inquiryindia@cognizant.com

© Copyright 2015, Cognizant. All rights reserved. No part of this document may be reproduced, stored in a retrieval system, transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the express written permission from Cognizant. The information contained herein is subject to change without notice. All other trademarks mentioned herein are the property of their respective owners.

About Cognizant

Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the world’s leading companies build stronger businesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 100 development and delivery centers worldwide and approximately 218,000 employees as of June 30, 2015, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: @Cognizant