|The FDA Center for Drug Evaluation and Research (CDER) is informing members of the pharmaceutical industry that its inspectors will increase enforcement of 21 CFR 11. Specifically, CDER will begin an inspection assignment of 21 CFR 11 requirements. This effort is part of CDER’s effort to evaluate industry compliance with 21 CFR 11. If inspections include observations that computer systems are not in compliance with 21 CFR 11, CDER intends on taking appropriate action to enforce Part 11 requirements. The timeframe for this CDER initiative has not yet been determined, but CDER wants the inspections implemented and completed soon.When distributing this information to members of the pharmaceutical industry, the key point was “Industry has had since August of 2003 to understand how we intend to enforce Part 11 as per the guidance and be in compliance. Therefore, the intention of CDER to take appropriate enforcement action should not be a surprise.”
21 CFR Part 11 sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.At this point, other FDA centers are not involved, but they have been informed of the CDER initiative and will be monitoring CDER findings.