US FDA Part 11 Compliance or EU Annex 11 Compliance

US FDA CFR Part 11 Compliance / EU Annex 11 Compliance

More and more companies are switching over to paperless records and computerised systems as a way to better keep track of all the data that can be accumulated during the manufacture, testing and release of a product. If you have any computerised systems or electronic records on site you’ll have to comply 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 and are not sure if it’s suitable or not, we can review it against the current regulatory requirements to ensure it is compliant before you start implementation (or before you commit to purchasing and 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 actions that may be required in order to comply with the 21 CFR Part 11 or PIC/S 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 actually released an updated risk-based guidance document in 2003 however, in spite of the release, 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.

More information:

If you have or are considering computerised systems and electronic records and are worried about compliance, or just have a  few questions you want to ask, please contact us.

To read more about related topics like GAMP & CSV and data integrity, click on the relevant links.