A risk-based approach to Computerized System Validation has been around for over 20 years, so what's the hype about CSA? Join us in this episode as we are joined by our amazing guest, Dr. Bob McDowall, to explore this question.
Bob McDowall is an analytical chemist with 50 years of experience including 15 years working in the pharmaceutical industry and 29 years as a consultant to the industry and suppliers to the industry. He has been involved with the validation of computerized systems for over 35 years and is the author of the second edition of a book on the validation of chromatography data systems published in 2017 and a book on data integrity for regulated laboratories in 2019.
Bob is the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns. One such column in September 2021 was entitled Does CSA Mean Complete Stupidity Assured? It is available online at:
https://www.spectroscopyonline.com/view/does-csa-mean-complete-stupidity-assured-