FDA finalizes guidance for 21 CFR Part 11

FDA has just released the final version of its guidance document "Part 11, Electronic Records; Electronic Signatures - Scope and Application." At first glance, there are not many changes from the draft guidance that FDA released in February. I do note, however, that FDA has clarified that users of legacy systems (systems in use prior to Aug. 20, 1997) are not totally off the hook. The guidance now says, "You [must] have documented evidence and justification that the system is fit for its intended use (including having an acceptable level of record security and integrity, if applicable)." The term "documented evidence," in my opinion, points to some level of system validation to ensure that the system is trustworthy and reliable.

The final guidance document is available on the FDA web site.

For more background on 21 CFR Part 11, see my post regarding the draft guidance in February. For perspective on how software vendors are addressing Part 11, see my post on Oct. 16, 2002.

I will be speaking on this subject later this month at the joint meeting of APICS and ISM in San Diego.