The QMN Weekly Bulletin

FDA to Start Part 11 Inspections After Seeing Compliance Issues

Aug. 27, 2010

The FDA will soon 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 in critical systems, George Smith, project manager officer in the Center for Drug Evaluation and Research’s Office of Compliance, said. Some of these issues may not have been obvious to industry as many of the citations were made to the predicate rule without Part 11 being mentioned.

What the FDA finds in the new inspections could lead to additional guidance, or the agency could decide to amend the existing Part 11 regulation or amend the current scope and application guidance, Gordon Richman, vice president of Strategic Compliance Consulting for EduQuest, said last month during an FDAnews webinar.
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