FDA Watch . . .Does 21 CFR Part 11 still apply?

By Mark Gunn
MGD Services

We have had clients inform us that many on their staff believe that 21 CFR Part 11 is no longer in force. 21 CFR is still in force and in all likelihood will be for some time. Some of the confusion arose out of the adoption of the 21st Century cGMPs for the Pharmaceutical industry. This initiative allows the pharmaceutical industry to be smart about compliance while putting the burden of proof on the industry itself. It requires documentation of risk analysis (Risk Based Approach) and the impact on patient health, product quality and data integrity. While this does narrow the interpretation and scope of Part 11 it does not eliminate it.

The current interpretation of the Part 11 rule focuses on only those records required by predicate rules (GLPs, GMPs and GCPs) that are in electronic format. This means that fewer records are covered and that predicate rule requirements are still enforced. The FDA still expects systems to be validated based on the predicate rules. You should consider the impact on accuracy, reliability, integrity, availability, and authenticity of any documentation that has been identified based on the risk based approach. You should base the approach on a justified and documented risk assessment that evaluates the effect on product quality and safety and record integrity.

What is still being enforced for Part 11 compliance is comprised of the following areas:

• Security


• Accountability for e-signatures


• Electronic signatures


• Operational, device, and authority checks


• Record protection


• Training and experience


• Open systems

At a minimum the Validation Plan and Report, Requirements, System Acceptance Test, IQ/OQ/PQ, and Maintenance Procedures are required to be validated. But with only these minimum requirements there are liable to be gaps in compliance if the required documents are not comprehensive and issued in a timely manor. The risk based approach must not be looked at as a way around the regulations but as a more structured and fairer approach to 21 CFR Part 11 compliance.

Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com