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Pharmaceutical Manufacturing and Packing Sourcer

Automated Regression Testing for Computer System Validation

This article discusses the role of computer-based regression for computer system validation. The approach can be used during system development and qualification protocol execution during system validation, revalidation and delta-validation. The computer-based approach allows rigorous testing and re-testing of system functions after any minor or major change. The benefits are a faster and cheaper validation cycle and more rigorous test cases and test results to ensure trustworthy and reliable systems that meet requirements.

Regulatory Enforcement Focus on Computer Systems

21 CFR Part 11 (Electronic Records and Signatures), the draft guidance on Part 11 (3) and the GAMP guide 4.0 (4) have a direct impact on computer system validation. For instance, Draft Guidance for Industry 21 CFR Part 11 (3) specifically mentions the terms functional testing ("§6.1.3 Functional Testing of Software"), structural testing ("§6.1.2 Software Structural Integrity") and regression testing: "Regression testing should be performed based on the results of the regression analysis"(§ 5.8 Change Control). The goal is to ensure trustworthiness and reliability of the systems and the records they manage.


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By Wolfgang Winter, Senior Product Manager of Data Systems at Agilent Technologies GmbH Wolfgang Winter is a Senior Product Manager for networked data systems with the pharma solutions business unit of Agilent Technologies, based in Germany. Wolfgang holds a masters degree in Electrical Engineering from the Technical University of Karlsruhe, Germany.
He has been working in software design, technical support and product marketing of software solutions for analytical labs since 1989. His current responsibilities include requirements analysis, consulting, product definition and implementation planning of networked data systems for the analytical laboratory, with a strong focus on GMP regulated operations and 21 CFR Part 11.
Wolfgang has become a frequent contributor in publications and industry seminars on computer validation, helping to analyse and resolve the implications of new regulatory requirements for example, for trustworthy electronic records managed within the lab.

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Wolfgang Winter
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