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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