Happy New Year Everyone.

I was wondering if Europe has an equivalent regulation to 21 CFR Part 11.

I am specifically interested in any European regulation regarding electronic audit trails.

Any direction is appreciated.

Best regards,

Mark

Happy New Year Everyone.

I was wondering if Europe has an equivalent regulation to 21 CFR Part 11.

I am specifically interested in any European regulation regarding electronic audit trails.

Any direction is appreciated.

Best regards,

Mark

Mark,

I moved your post to this forum. I hope you get responses soon.

Stijloor.

Please view GMP annex 11 (http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_04/gmp_annex_11_consult_200804.pdf)

Please also view this article (http://www.securityfocus.com/infocus/1756)containing links to relavant information

Jan

Got this from:
http://www.wikibiopharm.com/index.php?title=EC_Guide_to_Good_Manufacturing_Practice

Annex 11 Computerised Systems addresses the use of Computerised Systems in the Pharmaceutical Industry, and was included in the EU Guide to GMP in 1994.
Unlike its US equivalent regulation, 21 CFR Part 11, annex 11 does not specifically address the use of Electronic Signatures.
For Electronic Records Annex 11 and Part 11 contain broadly the same requirements:
although, of course, the wording is different, the intent and the meanings are the same; there are however a couple of differences in the requirements

Requirement..............Part 11.............. Annex 11
Validation.................11.10(a) ............. Paragraph 2
Copies .....................11.10(b) ............ Paragraph 12
Retrievability .............11.10(c) ............. Paragraph 13, 14
Access .....................11.10(d) ............. Paragraph 8
Audit trail ..................11.10(e) ............. Paragraph 10
System Checks ...........11.10(f), 11.10(g).. Paragraph 6, 9
Training .....................11.10(i) ............... Paragraph 1
System Documentation .11.10(j), 11.10(k) .. Paragraph 11
Disaster recovery ................................... Paragraph 15, 16
Data entry verification ............................ Paragraph 9
Location .............................................. Paragraph 3
Accountability ............ 11.10(j)
---------------------------------------------------------------

I'm currently working on a comparrison of the two from an equipment manufacturer perspective to figure out what we must do build GMP compliant systems for our customers.

FYI here (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm)you can find the European GMP.
Annex 11 is the one you'll be interested in, though it might be usefull to scan part I, chapter 3 aswell..

FMI from what side are you looking this?
designer/supplier or the regulated industry

Hope there are more who 'suffer' this dylemma :D
(and are willing to share their findings)

Also the ISPE (http://www.ispe.org/)might have some usefull insights on this matter.

Good luck