A Roadmap and Training Aid for Part 11$

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21 CFR Part 11 is a topic of current focus for FDA and industry. In February 2003 FDA announced a major change in direction regarding Part 11 and withdrew all previous draft Part 11 guidance and the Part 11 Compliance Policy guide. This indicates a significantly relaxed interpretation going forward and in a federal register announcement FDA made explicit its intent to intent to exercise enforcement discretion with respect to the validation, audit trail, record retention, and record copying requirements of part 11.

Part 11 is somewhat unique in that it applies across all industries regulated by FDA (Drug, Device, Food, Biologics, etc.) but is applied differently depending on the specific other regulations that apply to each industry (called predicate rules).

The most recent Part 11 documents released by FDA are:

FDA Clinical Trials Computer System Guidance – 051007-04d-0440-gdl0002-May2007

Part 11 Final Guidance 0803

Part 11 – cd0314

Part11 draft scope guidance 020203

SoftwareCPR has compiled a side by side of the guidance text and our explanatory text in the following training aid:

Part 11 Scope Guidance Draft – SoftwareCPR Training Aid

SoftwareCPR.com provides several additional training aides and the regulation. A reprint of a book chapter on Part 11(written prior to the redirection) is also provided:

SoftwareCPR 21 CFR Part 11 Memory Jogger

AABB Part11 Book Chapt 6 – Feb 2003 Redirection Update with SCPR cover page

Part11 Training Aide

Part 11 SW Assessment Job Aid

SoftwareCPR audit checklist for Clinical Trials Software Guidance which includes some Part 11 related information and interpretation

Part 11 Regulation only – no preamble

SoftwareCPR Part 11 Reference Manual containing many of the other documents listed here

SoftwareCPR highlights and explanation of Part 11

In addition the following FDA released information is available on www.softwarecpr.com:

Part 11 Regulation with preamble
ORA Inspections Operations Manual Excerpt on Electronic Copies and computerized complaint information
May 1999 FDA presentation on Part11 and ClinicalTrials Software
FDA CDRHQS Reg/CGMP Record Keeping Requirements From the FDA report to OMB

Many of these documents are available in a single pdf Part 11 reference manual:

SoftwareCPR Part 11 Reference Manual

Perform a search on Part 11 of this site and you will also find related information including:

• Lists of signature requirements of the Drug and Device GMPs
• Part 11 related warning letters
• The GAMP draft guidance on Part 11 dated September 1, 2000 for review
• Information on the Electronic Signature and Records Bill that is now law

For a partial list of software and services vendors that are aware of Part 11 and claim to provide Part 11compliant packages or solutions click:

Nugenesis Solution Provider Web Page

Earlier draft Part 11 guidances, presentations, and the Part 11 compliance policy guide that were withdrawn and are now obsolete are provided below for educational and historical purposes but do not represent current FDA thinking in this area.

FDA Part11 Compliance Policy Guide

The fifth draft guidance released Nov 12, 2002 is:

FDA Part 11 Draft Electronic Copies of Electronic Records 

The fourth draft guidance released Sep. 5, 2002 is:

FDA Part 11 Draft Maintenance of Electronic Records Guidance 

The third draft guidance released March 20, 2002 is:

FDA Part 11 Draft Time Stamp Guidance 

The first two draft guidances released for comment on Sept 24, 2001 are:

FDA Part 11 Draft Glossary Guidance

FDA Part 11 Draft Validation Guidance

Other useful information:

Jan 1999 FAQ slides on Part 11 by Paul Motise of FDA

Information on an FDA October 1999 Part11 videotape

We hope you find this Regulatory Roadmap on Part 11 useful.  If you have any suggestions to improve this Roadmap or to create similar Roadmaps on other topics let us know by leaving a message below: