spacer
home > pmps > summer 2002 > automated regression testing for computer system validation
PUBLICATIONS
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21 CFR Part 11 (Electronic Records and Signatures), the draft guidance on Part 11 (3) and the GAMP guide 4.0 (4) have a direct impact on computer system validation. For instance, Draft Guidance for Industry 21 CFR Part 11 (3) specifically mentions the terms functional testing ("§6.1.3 Functional Testing of Software"), structural testing ("§6.1.2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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.

spacer
Wolfgang Winter
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Sphere Fluidics Closes a $4.8 million USD (£3.7 million) Funding Round

Cambridge, UK, 10 June 2019: Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, announced today that it has closed an additional tranche of investment of $2.9 million (£2.2 million), securing a total of $4.8 million (£3.7 million) in investment. The funding will be used as working capital for the Company’s Cyto-Mine® Single Cell Analysis System, expansion of the UK facility and enable the doubling of personnel through the opening of a new US Sales Office and Demo Lab in California.
More info >>

White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement