Good Clinical Practice Guide
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Thread: SOPs

  1. #1
    Forum Member
    Join Date
    Nov 2011


    In a global company using paper SOPS which require SOP signatures from multiple locations, is it acceptable to print PDF copies for evidence of signature and store these as evidence of acceptance or is it required that the wet signatures are stored?

  2. #2
    Forum Member
    Join Date
    Nov 2015
    Bromley, Kent
    You can add either an electronic signature or a digital signature.

    Electronic signatures are cheaper to implement and can only be verified on the 'source' system

    Digital signatures require secure certification and have the highest form of security - these are independent of the 'source system'.

    Hand written signatures for SOPs may be substituted with electronic signatures - however you must consider whether the integrity, authencity and context of the electronic signature will be maintained through the documents entire retention period ( including archiving ).

    Therefore it is recommended digital signatures are embedded into the documents and more appropriate of long term retention.

  3. #3
    Forum Member
    Join Date
    Oct 2016
    CFR 21 Part 11
    (5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication,
    computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data
    can be verified
    (7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or
    authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

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