A lot has been written and discussed about Computer Software Assurance (CSA) and it being a revolutionary change to Computerised System Validation. It is, in fact, not that revolutionary, but more a re-alignment of the original intent of CSV. CSA involves ‘critical thinking’, the correct use of risk assessment and vendor collaboration.
The following set of articles explain what CSA is and some practical examples of how to implement it. The article below sets the scene of why CSA is needed and some key principles. https://blog.seerpharma.com/computer-software-assurance-csa
The article below explains the importance of risk assessment at the requirements/functional level to justify the validation / testing to perform later in the project. https://blog.seerpharma.com/computer-software-assurance-csa-risk-and-reward
The article below expands on the use of critical thinking and vendor knowledge to focus your validation effort. https://blog.seerpharma.com/computer-software-assurance-csa-use-of-critical-thinking
The final article looks at vendor / system level testing and using this knowledge to close the loop back in the final user acceptance testing. https://blog.seerpharma.com/computer-software-assurance-csa-configuration-design-and-closing-the-loop
If you would like to learn more about CSA and discuss how it can be applicable to your CSV efforts then register for one of our courses, run over two half days. Click here to to find when our next course is due to run.
Article Library
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Why do we not risk assess?
Madeleine Ault November 5, 2024 -
Distributing controlled drugs
Shams Choudhury March 21, 2024 -
Gamekeeper turned poacher
Shahbaz Sarwar October 5, 2023 -
Lacking integrity?
Madeleine Ault May 19, 2023 -
Responsible Person Refresher!
Shahbaz Sarwar March 22, 2023 -
Computer Software Assurance (CSA) and CSV
Shahbaz Sarwar May 12, 2022 -
Transport Management and GDP Compliance
Shahbaz Sarwar April 8, 2022 -
Choosing a Responsible Person
Madeleine Ault August 17, 2021 -
Use of stability data for temperature excursions in the wholesale supply chain
Shahbaz Sarwar July 28, 2021 -
Why Can't I Use Ex-Works
Madeleine Ault July 13, 2021 -
The Face Of Your Company
Shahbaz Sarwar June 13, 2021 -
Between A Rock and a Regulatory Place
Madeleine Ault May 14, 2021