Before revision: Content Subpart A – General Provisions Scope Implementation Definitions Subpart B – Electronic Records Controls for closed systems Controls for open systems Signature manifestations Signature/record linking Subpart C – Electronic Signatures General requirements Electronic signatures and controls Controls for identification codes/passwords History FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997) Various keynote speeches by FDA insiders early in the 21st century (in addition to high-profile audit findings focusing on computer system compliance) resulted in many companies scrambling to mount a defense against rule enforcement that they were procedurally and technologically unprepared for.
After revision: Content Subpart-A – General Provisions Scope Implementation Definitions Subpart-B – Electronic Records Controls for closed systems Controls for open systems Signature manifestations Signature/record linking Subpart-C – Electronic Signatures General requirements Electronic signatures and controls Controls for identification codes/passwords History FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997) Various keynote speeches by FDA insiders early in the 21st century (in addition to high-profile audit findings focusing on computer system compliance) resulted in many companies scrambling to mount a defense against rule enforcement that they were procedurally and technologically unprepared for.