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)

FDA Part 11 Compliance Committee’s Summary of the Public Conference on the Technical Implementation of 21 CFR Part 11 (Electronic Records; Electronic Signatures) held on June 19 & 20, 2000