Transcript About iAuthorize
Cognizant’s Validated e-Signature Solution
©2013, Cognizant
About iAuthorize
Cognizant’s proprietary validated electronic signature for authorizing Validation artifacts stored within HP-QC10 / ALM11
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
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.
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
• • •
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
• • • 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. 4 | ©2013, Cognizant
Key Features
Ensures Regulatory Compliance
Validated using Cognizant’s CSV Framework
Supports Bulk Approvals
Supports bulk approval of all artifacts which are reviewed
Provides Detailed Audit Trails
Provides detailed Audit trails in line with regulatory requirements 5 | ©2013, Cognizant
Easy to Customize
Easy to customize levels of approvals based on client’s needs
Generates Downloadable Validation Reports
Validation Summary reports downloadable as PDF/HTML
Easily Plugs-in the Existing Projects
Easy transitioning of projects into electronic documentation
End to End Support for Test Management
Supports all modules of HP-QC (Requirements, Test Plan, Test Lab, Defects)
Supports Non-Regulated Applications
Applicability in other industries like Food supplements, Healthcare, etc.
Triggers automated e-Mails
Collaboration of functional testers, IT Reviewers and QA Managers
iAuthorize vs Competition
Out of the box features Ease of Configuration for approval levels Pricing Bulk Approval Pre & Post Validation Summary report Download to PDF / html Support for Non-Regulated and Regulated applications
Audit Trail Ability to plug the workflow into existing projects.
Automated Email Notifications End-To-End Test Management
Cognizant E-Signature Easy Low Yes Yes Yes
Yes Yes Yes Yes
Widely Used e-Signature 1 Difficult High No No No
Yes Yes Yes Yes
Widely Used e-Signature 2 Difficult Medium No No No
Yes Yes Yes Yes 6 | ©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.
©2013, Cognizant