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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 industrys 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 Administrations (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 FDAs 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 companys 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 businesss operations. Life sciences companies, therefore, need an electronic authentication mechanism that demonstrates both functional and regulatory compliance.

    Figure 1

    Validations 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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    Cognizants 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 activi