What is FDA 21 CFR Part 11 European Equivalent?

Alexander Pavlović Date published: Feb 24, 20

Annex 11 is the FDA 21 CFR part 11 European equivalent. It is a guidance system for electronic records and electronic signatures in the pharmaceutical industry.

Annex 11 and FDA 21 CFR are two essential resources available to regulated life-science professionals regarding the validation of computer systems. While the FDA 21 CFR covers US-based pharmaceutical companies, Annex 11 is a Good Manufacturing Practice (GMP) guideline in the European Union.

21 CFR part 11 is a regulation of the FDA that applies to drug manufacturers, biotech companies and other regulated industries. Implementation of the regulation includes audit trails, electronic records and signatures and system validations.

While 21 CFR part 11 is only applicable for electronic records, EU GMP Annex 11 is not limited to electronic documents. The EU system applies to software, hardware, risk management and personal.

Despite their similarities, what you find is that both regulations are based on different regulatory structures and intentions.

Here at Ideagen, we have compared and contrasted the two regulations to make it a little easier to understand:  

Objective:

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

Timeline:

Part 11 is from the year 1997 (final rule) and Annex 11 is from 2011 (revision 1)

Titles:

US FDA Part 11 uses electronic records/electronic signatures whilst EU Annex 11 uses computerised systems

Context:

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

Relevance:

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

Validation:

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.

Read our case study to find out how the Blood Bank of Alaska met the FDA 21 CFR Part 11 requirement for electronic record and signature management.