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©2013, Cognizant Cognizant’s Validated e-Signature Solution
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| ©2013, Cognizant About iAuthorize 2 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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| ©2013, Cognizant The need for iAuthorize 3 High Costs of Paper Based Validation Paper based validation is Time consuming Emphasis on Green IT 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 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 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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| ©2013, Cognizant Working of iAuthorize 4 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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| ©2013, Cognizant 5 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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| ©2013, Cognizant 6 iAuthorize vs Competition Out of the box features Cognizant E-Signature Widely Used e-Signature 1 Widely Used e-Signature 2 Ease of Configuration for approval levelsEasyDifficult PricingLowHighMedium Bulk ApprovalYesNo Pre & Post Validation Summary report Download to PDF / htmlYesNo Support for Non-Regulated and Regulated applicationsYesNo Audit TrailYes Ability to plug the workflow into existing projects.Yes Automated Email NotificationsYes End-To-End Test ManagementYes
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©2013, Cognizant 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.
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