Computer System Validation for Pharmacometrics (Ep. 16)

This is the last podcast for 2023. Thank you for listening throughout the year! In today’s episode I talk about computer system validation for pharmacometrics. I review my experience with validation in multiple companies over 20 years and discuss what auditors and FDA inspectors want to see.

Links discussed in the show:

Computer system validation guidance for medical devices
Computer systems used in clinical trials
Computer system assurance guidance for medical devices
EMA guidance on computer systems and electronic data in clinical trials
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