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European equivalent for 21 CFR Part 11

European equivalent for 21 CFR Part 11
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.


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2 Comments:

  1. Anonymous said...
    The 'good article' linked here is all about digital (encrypted) signatures, whereas 21CFR11 is principally about electronic signatures which can be much simpler, such as capturing ID & password with time & date.

    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
    amaxson said...
    @Anonymous: Thank you for the great feedback! These are great things to point out.

    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

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