John Lee, Executive Director of Pharmaceutical Compliance Associates, and Henrik Johanning, CEO Genau & More discuss Computer Systems Validation and Part 11. When do you have electronic registrations and signatures and thus need to be in compliance with Part 11? When you press the enter button and you save data to a hard drive or USB drive, of course depending on whether or not you have to follow predicate rules (predicate rules interpreted as GMP).
Genau Talks is a series of videos that focuses on questions and tendencies within compliance. We would like to share these with you.