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Digital Signatures - Part 11 Compliant

chris_tech
Contributor

For anyone currently utilizing the Digital Signature feature offered by Archer - Do you know if the mechanism that facilitates that functionality is FDA Part 11 (Electronic Records, Electronic Signatures) compliant? If yes, do you have any documentation to support that? Otherwise, I plan on creating a custom object to interface with DocuSign's API and was wondering if anyone else has gone down a similar path?

2 REPLIES 2

AshleyMedina
Contributor III

It would be nice if someone from Archer could answer this question.

amurana-HHS
Contributor II

Hi, @DavidFreeman@DavidPetty,  @Ilya_IRM , 

I have two questions:  

1.  Are all of the three options of Archer OOTB E-Signature functionality FDA 21 CFR Part 11 (E-signature) compliant?  Can you clarify it?  Thank you.  

amuranaHHS_0-1718228042707.png

2.   We want to replace an old Archer OOTB E-Signature with a new one instead of appending the new one.  Does the AWF signature functionality have the capability?  DDE does not supports attachment fields to empty.  Users cannot replace it with the new one, either.  We currently use a DF to accommodate it.  Is this the only way?  

Thank you for the clarification.   AM