FDA and Industry Guidance for 21 CFR Part 11
When 21 CFR Part 11 was released in August 1997 the industry was not sure
on how to implement it. The FDA has released an number of guidance
documents, most of the have been withdrawn. Industry task forces have also
developed an published recommendation. This site includes links to all FDA
documents related to part 11. Withdrawn guidance are indicated as such.
FDA Regulations/Guidance
FDA Regulation
21 CFR Part 11: Electronic Records and Electronic Signatures
Published in August 1997
FDA Guidance
21 CFR Part 11: Scope and Applications
Published in August 2003
FDA Guidance
21 CFR Part 11: Compliance Policy Guide
withdrawn in February, 2003, as part of FDA's 21st century drug CGMP
initiative
FDA Guidance
21 CFR Part 11: Validation
This draft guidance has been withdrawn form the FDA Website as part of
the drug CGMP initiative for the 21st century. However, most of the
statements in the guidance are still very much appropriate and subject to
FDA inspections. The guide is especially useful for users of computer
systems.
FDA Guidance
21 CFR Part 11: Glossary of Terms
August 2000 (draft) (withdrawn)
FDA Guidance
21 CFR Part 11: Time Stamps
March 2002 (draft) (withdrawn)
FDA Guidance
21 CFR Part 11: Maintenance of Electronic Records
July 2002 (draft) (withdrawn)
FDA Guidance
21 CFR Part 11: Electronic Copies of Electronic Records
July 2001 (draft) (withdrawn)
FDA Guidance
Using Computers in Clinical Trials
May 2007
US FDA Information
IOM Chapter 5 Establishment Inspection
Subchapter 520+ :Electronic Records
Industry Contributions
Position Paper
PhRMA's Position on Part 11 - Letter to the FDA
Discussion Paper
Implementation of 21 Code of Federal Regulations, Part 11; Electronic
Records; Electronic Signatures; Scope of the rule
FDA discussion with Industry Coalition on Part 11
White Paper
ISPE: Risk-Based Approach to 21 CFR Part 11