FDA Announce Part 21 CFR 11 Inspections

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As detailed within the post 21 CFR Part 11 Warning Letters the FDA are planning to start conducting part 11 inspections soon.

Published on the FDA website the agency states:

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). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.

Links
Full announcement - FDA Website
Part 11 Comment - Blog
Electronic Records Article Risk Based Approach - CSV-QA.COM