Resources: A Partial List

This is not an all-inclusive list; however, it is intended to provide a few key useful resources.

Free FDA Resources

Code of Federal Regulations, 21 CFR Part 11; Electronic Records, Electronic Signatures; Final Rule, U.S. FDA, 20 March 1997; available from Internet: www.fda.gov [6]. Everyone on a company's Part 11 team should be familiar with the rule itself and the contents of its preamble, which describes FDA's thinking in publishing the rule. 

“General Principles of Software Validation: Final Guidance for Industry and FDA Staff,” U.S. FDA, Jan. 11, 2002; available from Internet: www.fda.gov [6]. Everyone who performs or reviews software validation in an FDA-regulated industry should know the contents of this document.
“Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application,” U.S. FDA, August 2003; available from Internet: www.fda.gov [6]. The newest guidance document narrowly interprets the scope of the regulation; highlights are discussed in this article.

Resources for Sale

“Good Practice and Compliance for Electronic Records and Signatures, Part 1: Good Electronic Records Management (GERM),” and “Part 2: Complying with 21 CFR Part 11, Electronic Records and Signatures” (Tampa, FL: ISPE, or Bethesda, MD: PDA, July 2002 and Sept. 2001), available from Internet: www.ispe.org [7] or www.pda.org [8]. The first booklet contains information to include in a systems SOP. The second guide contains gap analysis forms.

Although these booklets were published before FDA changed its interpretation of the rule, every organization that must comply with Part 11 should purchase these guides for its Part 11 team. All team members should read these guides.

Good Automated Manufacturing Practice Guide for Validation of Automated Systems (GAMP 4), (Tampa, FL: ISPE, Dec. 2001), available from Internet: www.ispe.org [7]. Mentioned by FDA in its most recent Part 11 guidance, this book contains basic information about validating computer systems, but seems light on protocol and report content.

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