About iAuthorize

Report
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
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• 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
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-toend testing process.
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Key Features
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Ensures Regulatory
Compliance
Easy to Customize
Validated using Cognizant’s
CSV Framework
Easy to customize levels of
approvals based on client’s needs
Supports Bulk Approvals
Generates Downloadable
Validation Reports
Supports Non-Regulated
Applications
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.
End to End Support for
Test Management
Supports all modules of HP-QC
(Requirements, Test Plan, Test Lab, Defects)
Provides Detailed
Audit Trails
Easily Plugs-in the
Existing Projects
Triggers automated e-Mails
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
| ©2013, Cognizant
iAuthorize vs Competition
Cognizant
E-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
Out of the box features
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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.
©2013, Cognizant

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