I was recently asked whether or not Europe had a regulation that was equivalent to 21 CFR Part 11, the FDA guideline that defines the criteria under which electronic records and electronic signatures are considered to be reliable.
Some research uncovered a good article with lots of relevant information. GPM Annex 11 also provides helpful information.
For daily updates, subscribe to Medical Translation Insight via email or RSS.
2 Comments:
Subscribe to:
Post Comments (Atom)
The GMP Annex linked here is an old version, the current one being at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-4/index_en.htm
however this says little about electronic signatures
For those interested in an introduction to 21 CFR 11, I found this to be a good resource as well: http://www.ofnisystems.com/Part_11/21_CFR_Part_11_Requirements.htm