21 CFR Part 11 - Some History

Below are a series of links to information about the 21 CFR Part 11 regulation. The links are organised in chronological order, starting with the publication of the 21 CFR Part 11 regulation on March 20 1997 (effective August 20 1997). These are followed by links to the draft and final versions of the Scope and Application guidance document, both published in 2003. Finally, there are links to documents that relate to the latest consultation exercise undertaken by the FDA.

	Final Rule (252 Kb)
	The 21 CFR Part 11 regulation as published in the Federal Register.

	Draft Scope and Application - Federal Register Notice (15 Kb)
	The notice in the Federal Register announcing the publication of the draft Scope and Application document.

	Draft Scope and Application (38 Kb)
	The 21 CFR 11 Scope and Application draft document issued for comment.

	Final Scope and Application (216 Kb)
	The issued version of the 21 CFR 11 Scope and Application document.

	June 2004 Public Meeting (886 Kb)
	The FDA's calling notice for the public meeting to be held on the 11th June 2004.

	June 2004 Public Meeting - Agenda (83 Kb)
	The draft agenda issued prior to the meeting being cancelled.

	June 2004 Public Meeting - Comments
	The FDA docket holding all of the comments.

	Slides from ACDM CSV SIG Meeting (92 Kb)
	Slides from the Association of Clinical Data Management (ACDM) Computer Systems Validation (CSV) Special Interest Group (SIG) meeting held in August 2004. Presentation presents industry's current concerns and looks forward to potential changes in the 21 CFR Part 11 rule. Note: Some of the content should be treated with caution as it is speculatory in nature.