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e-Signatures: Making Paperless Validation a RealityA paperless solution not only reduces printing costs; it also streamlines the entire life sciences regulatory submission and approval process, from CSV validation across the value chain.
Executive SummaryGlobal life sciences companies are increasingly storing documentation in electronic formats to improve operational efficiencies. The industry’s embrace of a paperless environment is also driven by cost-cutting objectives and green IT principles. As such, organizations are adopting electronic records to establish validation of appli-cations during computer systems validation (CSV) processes.
As life sciences companies transition to electronic documentation, regulators have enacted security policies and practices to guard electronic infor-mation. The U.S. Food and Drug Administration’s (FDA) Title 21 Code of Federal Regulations Part 111 and EudraLex Annex 112 regulations mandate adequate control of electronic records and signatures that are used as objective evidence of a validated state of applications. To comply and protect themselves from financial penalties, companies use robust security measures to preserve electronic information. HP Quality Center is the tool of choice for managing electronic documents, as it facilitates the efficient storage and retrieval of controlled copies for future audit purposes.
We have developed an e-signature solution, iAuthorize,™ that does away with traditional
paper-based CSV processes and enables life sciences companies to create electronic signa-ture-based approvals for submission to external regulatory agencies.
This white paper demonstrates how companies using this solution can significantly reduce paper printing costs, minimize the transportation of wet-ink authenticated artifacts and reduce the time taken to complete the entire documentation approval, including security measures for main-taining paper-based records for the specified archival period.
Need for Electronic SignaturesStringent regulations enforced by various global regulatory authorities require life sciences companies to validate and demonstrate compliance of prescribed information systems or applications used to support core business processes. This demonstration of fitment is called computer systems validation (CSV).
Paper-based validation projects consume an average of 300 pages of printed copies of scripts. Scanning these scripts for subsequent manual authentication multiplies the project cost. Added to those expenses is the incremental cost of maintaining these documents in a physical state for the stipulated archival period, which includes
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storage in weather-resistant cabinets. A simple validation project with mandatory documentation and wet approvals can consume more paper than imaginable.
Figure 1 represents a sample from a simple validation engagement with two levels of review and approval. Over 3,000 pages are printed for one review and approval cycle to meet the mandatory documentation required for validation.
Regulations
The first and most significant regulation that was initiated in this respect was the FDA’s Title 21 Code of Federal Regulations (CFR) Part 11. Various other geographies, such as the European Union (with EudraLex) and Japan (with the Pharmaceuticals and Medical Devices Agency, or PMDA), base their mandates for electronic document controls pre-dominantly on the 21 CFR Part 11 guidelines.
According to 21 CFR Part 11, “Persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met,” and that a docket stating a company’s intent has been submitted to the FDA. Subpart B on the usage of electronic records establishes the system controls that must be in place if electronic records and signatures are to be used.
The mandate stipulates that electronic signatures should be linked to their respective electronic
records to ensure that the signatures cannot be excised, copied or otherwise transferred to falsify an electronic record by ordinary means. It also states that electronic signatures must be “unique to one individual and shall not be reused by, or assigned to, anyone else.” They may be based on biometrics or an identification code/password combination.
EudraLex Annex 11, which is applicable to companies doing business in the EU, modified its PIC/S-11 to Annex 11 in June 2011. The provisions state: “For critical data entered manually, there should be an additional check on the accuracy of the data. This check may be done by a second operator or by validated electronic means. The criticality and the potential consequences of erroneous or incorrectly entered data to a system should be covered by risk management.”
Complying with these two critical pieces of legis-lation allows life sciences organizations to meet the compliance requirements of major geogra-phies, as they form the superset of guidelines for control of electronic documents.
Granting approval to use electronic records and electronic signatures, 21 CFR Part 11 and EudraLex Annex 11 represent a paradigm shift by allowing major efficiency improvements in the business’s operations. Life sciences companies, therefore, need an electronic authentication mechanism that demonstrates both functional and regulatory compliance.
Figure 1
Validation’s Paper Volume
Wet Signature
900 Pages
300 Pages 150 Pages
150 Pages
150 Pages
150 Pages
300 Pages
300 Pages
300 Pages
Analysis Design Execution
Two
Env
iron
men
ts
Closure
BRDDocument
50 Pages
FHSDocument
80 Pages
Test Strategy
30 Pages
RiskAssessmentDocument30 Pages
DesignDocument
50 Pages
ValidationPlan
60 Pages
IQ Scripts
10 Pages
PQ Scripts
40 Pages
TraceabilityMatrix
20 Pages
OQ Scripts
80 Pages
IQ Logs
20 Pages
PQ Logs
30 Pages
Screen Shots
160 Pages
OQ Logs
120 Pages
SummaryReport
20 Pages 80 Pages
DefectReports
30 Pages
OtherMandatory
Docs100 Pages
UserManuals
Wet Signature
450 Pages
Wet Signature
990 Pages
Wet Signature
690 Pages3,030 Pages!!
Total
Pages
Printed
Across
Lifecycle
Approver
Reviewer
Creator
Test Lifecycle
=330 Pages
330 Pages
330 Pages
330 Pages 230 Pages
230 Pages
230 Pages
230 Pages
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Cognizant’s e-Signature Solution: iAuthorizeTo better manage and control their electronic documentation and meet the requirements of 21 CFR Part 11 and EudraLex Annex 11 provisions, we developed iAuthorize to complement test management tools used in the electronic storage of validation artifacts. This solution negates the need for printing documents solely for the purpose of capturing a handwritten signature, thereby establishing a fully electronic process. Based on our assessment, deploying this solution can potentially save up to 15% of the cost of validation for life sciences organizations and enable them to embrace environmentally friendly “green” policies.
Solution Demystified
iAuthorize is built on top of HP-Quality Center, the most widely used test management tool across regulated industries, which forms the repository of controlled copies of validation documents. It is a closed system, as mandated by regulatory guidelines, where access is controlled by individu-als responsible for the content and control of the electronic records.
iAuthorize integrates with any lightweight directory access protocol (LDAP) or user authen-tication system to provide digital authentication. It enables “end-to-end” authentication support
of test management processes, such as require-ments management, test plan, test execution and defect management modules commonly found in test management tools. It does this by enforcing workflow with electronic signatures across the spectrum of test management processes. Built-in flexibility enables compatibility with both regulated and non-regulated projects (see Figure 2).
While our solution is aimed primarily at life sciences companies, it can also be used in other industries where regulatory documentation mandates and compliance leg-islation requires electronic signatures and digital authenti-cation of electronic documents.
Salient features of iAuthorize include:
• Ease of customization of workflows: Helps enable users to customize levels of authenti-cation, thereby providing the scalability and flexibility to customize workflows according to need.
• Support for bulk approvals: Supports bulk approval of all artifacts, which are duly reviewed and signed off from a regulatory perspective.
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.
Figure 2
iAuthorize Overview
Checks in Testing Artifact
System Triggers Mail RequirementsiAuthorizeTool Add-in
LDAP/User Authentication
Module
Test Plan
Test Execution
Defects
Electronic Signature
ValidationLead
ValidationAnalyst
HP ALM ModulesHP ALM Workflow
Customization
Reviews and Approves
System Triggers Mail
Electronic Signature
ValidationLead
Reviews and Approves
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• End-to-end support of test management activities: Supports test management process-es such as the requirements, test plan, test lab and defects modules of HP QC 10 and HP ALM 11.
• Generation of downloadable validation summary reports: This out-of-the-box feature enables generation of downloadable validation summary reports in PDF or HTML formats.
• Audit trails: Provides detailed audit trails for stakeholders and regulatory organizations.
• Applicability in other industries: Suitable for other regulated industries, such as healthcare, food products, health supplements, etc., that mandate electronic signatures.
Detailed audit trails and automated review and approval mechanisms ensure compliance with 21 CFR Part 11 and EudraLex Annex 11 guidelines. Notification to individual owners and stakehold-ers about status and state transitions is enabled through automatic e-mail notification function-ality. The solution is readily adaptable through configurable workflow customization, aligned to the individual organization’s validation processes. The security and authentication mechanisms are in line with 21 CFR Part 11 and EudraLex Annex 11 requirements, which warrant dual authentica-tion credentials. This solution currently uses the User-LDAP authentication feature of HP Quality Center, wherein a unique user ID and associated
password is used for managing the approval process.
While ensuring that regulatory compliance is the primary focus of the digital signature process, this solution also provides an ideal platform for life sciences organizations that want to move toward paperless validation and completely discard the use of printed versions of validation artifacts. In a nutshell, this solution provides a secure and con-figurable approval process for use in regulated environments by electronic signatures.
iAuthorize has been systematically validated in line with our CSV framework (aligned with GAMP guidelines) to meet adequate documentation and objective evidence regulatory requirements (see Figure 3).
Integration with HP Quality Center
iAuthorize provides ready integration with HP Quality Center, helping clients save time and effort related to protocol design for tool validation and development of add-ons to the test management tool. As this solution is built over HP ALM 11.0/HP QC, it enables clients to leverage existing invest-ments in tool licenses. The active version of the solution framework currently works with HP Quality Center on both HP ALM 11.0 and HP QC 10.0 as the test management tool.
Figure 3
iAuthorize Benefits
Regulatory ComplianceDemonstrated compliance with life sciences predicate rules.
Faster Turnaround Time Automated process reduces manual intervention and removes inefficiencies.
Hassle-Free AuditsArchiving functionality to store documents and test assets in a single place with detailed audit trails.
Cost BenefitsAchieves up to 10% cost benefits compared with a paper-based validation model.
Effective Test Management Built in adapter for HP QC Test Management tool for straight- through QA-related data transmission.
Secure AccessElectronic encryption function for higher security of electronic signatures.
About CognizantCognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process out-sourcing 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 50 delivery centers worldwide and approximately 156,700 employees as of December 31, 2012, 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.
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© Copyright 2013, 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 the AuthorsRangarajan Rajamani is a Consulting Manager in Cognizant’s Quality Engineering & Assurance Services business unit and has over 11 years of experience in consulting and developing solutions along the themes of regulatory compliance and operational excellence in the life sciences industry. Rangarajan was a key member of the team that developed iAuthorize. He has worked in global pharma regulations, CSV lifecycle, pharmaceuticals manufacturing and compliant supply chains, sales and channel management, solution prototyping and back-end support for business development. Rangarajan has supported over 25 QMS and process audits and five vendor code of conduct (CoC) audits across industries. He can be reached at [email protected].
Sagar Mundada is a key member of Cognizant’s Quality Engineering & Assurance Services business unit and has over 10 years of experience in HP test tools administration (TD 7.6, QC 10.0, HP ALM 11.0, HP QTP, PC). Sagar was the quality center expert who created the e-Signature workflow architecture built on HP QC and has developed tools and utilities to automate the HP QC administration activities. He has also created reports using HP Delivery Dashboard and integration with third-party tools. Sagar worked on projects connected with various GXP and 21 CFR Part 11 compliance used in life sciences, imple-mentation and maintenance of frameworks that replace traditional paper-based manual CS processes, enabling electronic signature-based approval for submission to many global pharmaceutical and biotech companies. He can be reached at [email protected].
G. R. Ragesh is a key member of Cognizant’s Testing Center of Excellence R&D team, with over seven years of experience developing innovations, tools and frameworks related to test automation. He is responsible for developing the electronic signature framework that runs on top of the HP QC LDAP authentication process. Ragesh can be reached at [email protected].
Rahul Deshpande is a Senior Manager in Cognizant’s Quality Engineering & Assurance Services business unit. Rahul has over 13 years of experience in test consulting and designing innovative solutions for the life sciences industry. He manages the QA delivery and client relationships of Cognizant’s life sciences industries in North America. Rahul led the team that developed iAuthorize from concept to product rollout. In his current role, Rahul provides thought leadership and implementation assistance to clients as they transition in QA maturity. He can be reached at [email protected].
Footnote1 “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application,” U.S.
Department of Health and Human Services, August 2003, http://www.fda.gov/downloads/Drugs/Guid-anceComplianceRegulatoryInformation/Guidances/ucm072322.pdf.
2 “EudraLex Annex 11: Computerised Systems,” European Commission Health and Consumers Directorate-General, http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf and http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx11_en.pdf.
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