FDA releases 21 CFR Part 11 guidance document

Washington, DC – On November 8, 2002, the newest Part 11 FDA Draft Guidance Document ”Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records” was made available for 90 days for public comments. To obtain a copy, visit www.fda.gov/cber/fglns/esigtime.htm

Related information

Over 300 people recently participated in a poll dealing with electronic records and signatures in laboratory systems. The results of the poll titled, ”The Paperless Lab” is available at www.21cfrpart11.com/pages/poll/compliance_poll_result.pdf .

A document titled, ”Good Practice and Compliance for Electronic Records and Signatures,” provides an excellent regulated-industry guide to current good practices for electronic records and signatures. To order a copy, visit www.pda.org

Many companies have global concerns concerning electronic records and signatures. A translation of the “German Digital Signature Law-Final Version, June 13, 1997” is available at www.kuner.com/data/sig/digsig4.htm

The April 2002 issue of Control Engineering included ”I’m from the Government, and I’m Here to Help You.” The tongue in cheek title was the lead-in to an article about the U.S. Food and Drug Administration’s regulation on electronic records and signatures, more commonly known as 21 CFR Part 11.

A follow up article is planned for May 2003 to discuss successes and lessons learned. If you have something related to electronic records and signatures to share, e-mail dharrold@reedbusiness.com .

Control Engineering Daily News DeskDave Harrold, Senior Editor dharrold@reedbusiness.com

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