EU Annex 11 vs FDA 21 CFR Part 11

Last week at the Qualsys GxP Quality in Life Science event, Kaye Eames, Training Manager at Qualsys discussed Electronic Records and Electronic Signatures. 

During the presentation, Kaye discussed the differences between EU Annex 11 and FDA 21 CFR Part 11. 

Some people try to map out Annex 11 and Part 11. But in my experience, this is nearly impossible and not useful.

While it might be alluring to compare both regulations because the number 11 is identical and the context seems to be similar, what you find is that both regulations are based on different regulatory structures and intentions.


Below we've compared and contrasted the two regulations:  



US FDA Part 11 


EU Annex 11


Final objective of Annex 11 and Part 11 is mirrored. A modern validation approach will normally result into compliance for both regulations.


Part 11 is from the year 1997 (final rule)

Annex 11 from 2011 (revision 1)


Electronic records / electronic signatures

Computerised systems


There are differences! Context may seem similar but both regulations are based on different regulatory structures and intentions.


Part 11 is based on the basic prerequisite that systems are validated according to GMP

Part 11 is relevant for GMP, GDP, GLP, GCP and medical devices.

Annex 11 is relevant to GMP, but referenced also in other areas.


Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

On top of the V-model approach it combines elements such as risk, project, data, IT service and security, supplier & contract, release, requirements, test, development life cycle, and documentation management.



Qualsys provides quality management software which aids compliance to FDA 21 CFR Part 11 and EU Annex 11 for electronic record and signature management. For more information about using our software for FDA compliance, please visit:


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Topics: FDA

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