FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs

FDA has announced (08-July-2010) 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).”

It has been about seven years that US-FDA has debated 21 CFR Part 11 requirements and began using “Enforcement Discretion.” FDA announced that: “The Agency expects to begin conducting the Part 11 focused inspections soon.”

Check now your 21 CFR Part 11 compliance status!

Open link to FDA announcement here.

Update July 2011: Rethinking Part 11 Article.(DIA 2011 conference in Chicago)