21 CFR Part 11 / Annex 11 compliance

US FDA CFR Part 11 Compliance / EU Annex 11 Compliance

US FDA CFR Part 11 compliance means complying with the regulatory requirements for Electronic Records and Electronic Signatures (ERES) as outlined in the US Code of Federal Regulations (CFR) Part 11, or those documented in EU or PIC/S Annex 11.

Is your computer system compliant with Part 11 / Annex 11?

If you are considering a new computer system we can review it against the predicate rules to ensure it is compliant before you start implementation (or before you sign any contracts!).

If you have an existing system and you aren’t sure if it needs to be compliant or if it even can be made to be, we’ll review it and recommend any remediation required to comply with 21 CFR Part 11 or Annex 11 requirements.

A common mistake is to ignore the predicate rules and incur unnecessary expense doing work that that is not required. The FDA released an updated risk-based guidance document. In spite of the release, in 2003, it is still common to see over-elaboration on this requirement.

Putting the systems and documentation in place

During our work on Part 11 compliance with our customers, we’ve developed robust procedures and assessment templates for this area. We’ll ensure that you have the correct documentary evidence to ensure compliance with the CFR’s and regulatory requirements – making your next audit a success.

To learn more:

Please contact us to discuss your needs