Here it comes… The FDA to conduct 21 CFR 11 Inspections

As many predicted, the FDA has announced that they will be conducting  inspections to evaluate industry’s compliance and understanding of  Part 11 after the publication of the  ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance)’.(See FDA Regulations).

It will be interesting to see the results of the evaluation as to what was the impact of the new guidelines.  Did we change our approach to Part 11 after the new guidance was issued?