| Compliance > |
Electronic Records and Electronic Signatures
What does FDA say about electronic records?
| History of the Regulation (21 CFR
Part 11)
Final Rule: Establishment and Maintenance of Records Under the
Public Health Security and Bioterrorism Preparedness and Response Act of
2002, 9 December 2004 [HTML]
[PDF Proposed Rule: Food for human and animal consumption;
manufacturing, processing, packing, transporting, distribution, etc.;
records establishment and maintenance 9 May 2003 [HTML]
[PDF
Final
Rule on Electronic Records and Electronic Signatures, 20 March 1997 [PDF
( Proposed Rule on Electronic Records and Electronic Signatures, 31 August 1994 Advanced
Notice of Proposed Rulemaking, 21 July 1992 FDA's
E-Sig Working Group's Progress Report, 24 February 1992 |
Guidance for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application [HTML] [Word] [PDF] (September 2003)
ISPE Presents White Paper to FDA on 21CFR Part 11
Side by Side Comparison of Proposed and Final Rules
Products Available to Assist With Part 11 Compliance
GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.
