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Cognizant’s Validated e-Signature Solution

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About iAuthorize

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Cognizant’s proprietary validated electronic signature for authorizing Validation artifacts stored within HP-QC10/ALM11

iAuthorize can potentially save up to 15% of the cost of validation for Life Sciences organizations and enable them to embrace

environmentally friendly “green” policies.

iAuthorize is a closed system, as required by regulatory guidelines, where access is controlled by individuals responsible for the content and control of the electronic documents. Access control is in line with 21 CFR Part 11 and Eudralex Annex-11 guidelines

While iAuthorize is aimed primarily at Life Sciences industry, it can also be used in other industries where documentation requires electronic signatures to authenticate electronic documents.

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The need for iAuthorize

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PROCESS REGULATORY TECHNOLOGICAL

• High Costs of Paper Based Validation

• Paper based validation is Time consuming

• Emphasis on Green IT

• 21-CFR-Part 11 and Eudralex-Annex 11 mandate electronic signatures

• Need to enforce secure and configurable approval process for testing artifacts in regulated environments

• Increased acceptance of HP QC in Life Sciences and documents stored in electronic formats

• Limited out-of-the-box functionalities for widely available e-Signature solutions

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Working of iAuthorize

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• iAuthorize integrates with LDAP or HP QC user authentication system for generating electronic Signatures.

• iAuthorize provides complete traceability and accountability with detailed Audit Trials, thereby ensuring compliance with regulatory requirements.

• iAuthorize also leverages the features of HP Quality Center and Workflow to manage the end-to-end testing process.

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Key Features

Ensures Regulatory Compliance Easy to Customize End to End Support for

Test Management

Supports Bulk Approvals Generates Downloadable Validation Reports

Supports Non-Regulated Applications

Provides Detailed Audit Trails

Easily Plugs-in the Existing Projects Triggers automated e-Mails

Validated using Cognizant’s CSV Framework

Easy to customize levels of approvals based on client’s needs

Supports all modules of HP-QC(Requirements, Test Plan, Test Lab, Defects)

Supports bulk approval of all artifacts which are reviewed

Validation Summary reports downloadable as PDF/HTML

Applicability in other industries like Food supplements, Healthcare, etc.

Provides detailed Audit trails in line with regulatory requirements

Easy transitioning of projects into electronic documentation

Collaboration of functional testers, IT Reviewers and QA Managers

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iAuthorize vs Competition

Out of the box features CognizantE-Signature

Widely Used e-Signature 1

Widely Used e-Signature 2

Ease of Configuration for approval levels Easy Difficult Difficult

Pricing Low High Medium

Bulk Approval Yes No No

Pre & Post Validation Summary report Download to PDF / html Yes No No

Support for Non-Regulated and Regulated applications Yes No No

Audit Trail Yes Yes Yes

Ability to plug the workflow into existing projects. Yes Yes Yes

Automated Email Notifications Yes Yes Yes

End-To-End Test Management Yes Yes Yes

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Thank you

© Cognizant Technology Solutions 2013. All rights reserved. Cognizant owns all rights in all its trademarks, trade names or logos and any other intellectual property used in the presentation. Cognizant acknowledges the proprietary rights of other companies to the trademarks, product names and such other intellectual property rights mentioned in this document. Cognizant believes the information in this presentation is accurate as of its publication date, however such information is subject to change without notice. Except as expressly permitted, neither this presentation nor any part of it may be reproduced, stored in a retrieval system, transmitted or modified in any form or by any means, electronic, mechanical, printing, photocopying, recording or otherwise, without prior written permission of Cognizant Technology Solutions.