GMP Detox 21 CFR Part 11 Time Travel

Predicate Rules, Federal Register - US-FDA
US-FDA 21 CFR Part 11 - 1997 - final rule
US-FDA Guidance for Industry - Part 11 - Validation, Time Stamp etc. (Draft Versions)
ISPE - Risk-based approach Part 11 - Letter (2003)
Guidance for Industry - Part 11 - Scope and Application (Draft - Feb. 2003 / Final August 2003) - narrow interpretation
Type of signature - applicable sections of 21 CFR Part 11
Comply with ERES - Procedural and Technical considerations - Responsibilities by contract giver AND contract acceptor
Share Responsibilities - Matrix
How to Comply with Part 11....

[@iskandarhussain]

This channel is gold for anyone in pharma ‼️
Really nice content and good for refreshing memory and getting some of the background.

[@markusroemer11]

Glad you enjoy it!