What is EU Annex 11 Compare FDAs Part 21 CFR Part 11 and the

\"What is EU Annex 11? Compare FDA’s Part 21 CFR Part 11 and the EU’s Annex 11.\" Briefly answer following questions:

Are there different CSV requirements for US FDA and Europe?

How to justify and document that we have selected the right vendor?

How much can we rely on vendor certificates and documents?

Solution

1) EU Annex 11 : This guidance is the one used by the FDA for interpretation and to enforce the Part 11 requirements established in the Part 11 regulation. . European Union (EU) Annex 11 covers the interpretation of the principles and guidelines of GMP-regulated activities to computer systems.

2) Both FDA\'s PArt21 CFR Part 11 and EU\'s Annex 11 cover the topic use of computer systems in regulated activities.

Annex 11 is a detailed guide of rules that need documentation. It points to risk assessment in the start of compliance activities . Where are Part 11 differentitates security for open and closed systems with extra security measures for open systems without taking risk into consideration. PArt 11 uses electronic records and signatures in open and closed computer systems

3)CSV requirements are handles in PArt 11 where are in Annex 11 requirements are not covered

4) Selection of the vendor depends on the requirement of regulations . Annex 11 has a much broader scope than Part 11. Regarding e-recs and e-sigs, Part 11 goes beyond Annex 11, but Annex 11 works well with 21 CFR Part 11.One can choose Annex 11 in different regulated environments, such as the United States, as a regulatory guideline to comply with the regulatory requirements applicable to computer systems supporting GxP applications.

The Part 11 has started the awareness of regulated industry on e-recs and e-signatures. The updated EU Annex 11 has improved the standard for regulated users and systems. EU Annex 11 gives the specific guidance in areas that are not covered in Part 11 regulations.