FDAnews Drug Daily Bulletin

FDA to Start Part 11 Inspections After Seeing Compliance Issues

Aug. 17, 2010
The FDA will begin inspections to determine companies’ compliance with electronic records guidelines under 21 CFR 11 (Part 11). The agency has seen a variety of compliance issues, ranging from insufficient computer system validation to missing audit trails, George Smith, project manager officer in CDER’s Office of Compliance, said. Some of these issues may not have been obvious to industry since many citations were made to the predicate rule without Part 11 being mentioned, he added.
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