Compliance Issues with 21 CFR Part 11 Standards

Did You Know?

The inspections are due to occur "soon" according to an announcement made by FDANews and the inspections are expected to lead to 1) additional guidance, 2) an amendment(s) to the Part 11 regulatory text, or 3) both.

According to George Smith1, quoted in a recent FDANews update, "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."

Some of the compliance issues that the FDA has noted include insufficient or inadequate electronic system validation and missing audit trails in electronic systems.

The moral of the story is to check and recheck compliance with 21 CFR Part 11 standards. A company should at least achieve minimal standards.


1. George Smith is the Project Manager Officer in the Center for Drug Evaluation and Research's Office of Compliance.