Computer Software Assurance (CSA) and CSV

May 2022

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, then click the banner below: