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
- You can connect with me on LinkedIn and send me a message
- Send me a message
- Sign up for my newsletter
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