Part 11: It’s Back


Part 11 FDA

FDA To Resume Enforcement of Part 11

FDA has announced that “The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance).” This is a big deal. It has been seven years that FDA has debated Part 11 and began using “Enforcement Discretion.” The Agency announced that: “The Agency expects to begin conducting the Part 11 focused inspections soon.” Part 11, Electronic Records; Electronic Signatures has been one of the most confusing and controversial regulations FDA has ever written. I am now trying to find a Part 11 specialist to let us know the meaning of it all. Read what FDA has to say:

FDA Part 11 Announcement

UPDATE: Read the 25 July Guest Commentary on Part 11 by Len Grunbaum & Emma Barsky

The early report: The best report so far: Angie Drakulich goes into further detail on the changes including an interview with FDA in her report in the blog, PharmTech Talk

ALSO: Please join me at:

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The Blog has just been put on the expanded Top 50 Health Blogs list, which I truly appreciate. However, they constantly change their links to keep it current. Currently I am not there although there are other interesting posts. I now have two “Top Fift” links on the Blogroll.

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