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Wet ink and electronic signatures on the same document

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  • Anon
    28/02/2019 10:17
    Anyone have any insight on combining wet ink and electronic signatures in one document? For ex, if a company has an e-signature tool and uses this on a document that also needs to be signed by a vendor or client who doesn't have this technology? Can they e-sign and then ask the other party to print/sign/scan? I am curious about (1) whether or not this would violate the 21 CFR Part 11.70 requirements for signatures to remain linked to the signed record and for alteration to be detectable, (2) what would need to be archived (is the 'hybrid' document a certified copy of the e-signature, or would you need to archive both the e-signature and wet ink signature documents?), and (3) if the order of signature application matters (i.e. if it's better to sign in wet ink first so that e-signature remains intact)? Thanks in advance!
  • Trev Simmons (DIGIT)
    28/02/2019 10:36
    As you say in your message, the difficulty with using both wet ink and handwritten signatures on the same document is you need to deal with: - Record to Signature Link - Electronic Signature 'Validity' - Copy Certification If you put electronic signatures first, and then the document is printed, signed and scanned. the electronic signature would only be the manifestation part in the final document. depending on the e-Signature solution used, building a mechanism to validate the e-Sig and control the print and wet signature to keep it certified, would be complex and a lot of bureaucracy that the wet signing clients are unlikely to wish to do. If wet signatures were applied first, scanned and then that document signed electronically, the certification process for the wet signature scan would be simpler, but I know that many organisations would just go with keeping the signed originals. But if you have a prescribed signature order Wet before electronic may not suit you. Because of those aspects what I have seen more often than not, is that if the client wants to use Wet Signatures, that the service provider uses wet signatures as well. Good luck, I will do some more digging though.
  • Anon
    28/02/2019 11:51
    Thanks very much, Trev. This is really helpful. I would appreciate it if you could find / advise further. This was all I came across in my search: http://forums.mhra.gov.uk/showthread.php?1863-Mixing-ink-and-digital-signatures
  • MJ
    12/07/2019 16:04
    Hi, I know you can always scan docs and load them into the software to sign. From experience, I know www.signable.co.uk does them. greetings MJ
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