Good Clinical Practice Guide
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Thread: Mixing ink and digital signatures

  1. #1
    Forum Member
    Join Date
    Aug 2015

    Mixing ink and digital signatures

    I can't seem to find much information regarding the acceptability of mixing digital and ink signatures.
    For example, if a Requirements Specification must be signed by the vendor and the client, and the vendor initiates it using a digital signature, is it acceptable for the client (who doesn't have the same digital signature software) to hand-sign a printed copy of the digitally-signed document?
    If anyone may please advise, I would appreciate it greatly.

  2. #2
    To the best of my knowledge there is no regulatory guidance here. So we need to look at this from a practical and a legal perspective. If a party to a document does not have the tools to sign digitally, then there is no choice but to sign in wet-ink. It is perfectly acceptable to sign a copy of the digitally signed document with a wet-ink signature. However, this ONLY provides their signature. The printed copy of the digital signature is NOT an original signature and is only a copy of a signature (and likely not to be considered a certified copy as it wil not contain all of the same attributes as the original). Therefore, the party who initiated the signing process now has to retain two copies of the document, one with a digital signature of one party and one with a wet-ink signature of another party. Of course the wet-ink signed copy could be digitised BUT you would need to ensure the scan is a certified copy. Furthermore, attempts to insert a scanned page into a digitally signed document will invalidate the digital signature. If wet-ink signing really is the only option, obtain the wet-ink signatures first, generate a certified copy through scanning and then obtain the digital signatures.

  3. #3
    I am working for a French pharmaceutical company, and we are thinking on the same question: one of our vendors has only manual signature process and we have a possibility to sign electronically. Shipping documents across the country is neither cost and time effective nor environmentally friendly. From my previous experience in a CRO I remember that mixing up the wet ink and electronic signature was acceptable as long as the handwritten one comes first. Since signaling a document electronically encodes the document, doing overwise would invalidate the eSignautre. What do you think on this approach?

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