FDA Increasing Emphasis on 21 CFR 11

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 the CDER 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 to take 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.”

At this point, other FDA centers are not involved, but they have been informed of the CDER initiative and will be monitoring CDER findings.

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 the FDA responsibility to protect the public health.

Ofni Systems can make sure you are prepared

Ofni Systems are experts in 21 CFR 11, working with FDA-regulated businesses and regulatory bodies themselves to ensure that the requirements for computer systems are understood and fullfilled. We can help your business achieve compliance by:

• Training your employees on the requirements of 21 CFR 11.
• Assessing your systems for compliance with 21 CFR 11.
• Auditing your systems and reporting on your level of preparation.
• Part 11 Advisor, which facilitates computer system compliance assessments, including creating Corrective Action Plans.