E-signatures for QMS?

A

asantcom

AS345
#1
#1
I work for a super small company (only 3 people will be interacting with our QMS) so we are using Google Drive (with lots of approbation features). Last detail we have to sort out is the e-signature process. 21 CFR Part 11 makes this tricky. We have looked into docusign, Adobe sign, mySignatureBook. Does anyone have any experience with this and any recommendations?
 
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Mustapha

Mustapha

Starting to get Involved
#3
#3
I would recommend Docusign. They have a simple whitepaper that outlines how their solution meets the criteria in part 11 that you can follow when you write your validation protocol.
 
C

Chrisx

Involved In Discussions
#4
#4
The whitepaper I have from DocuSign says that to comply with part 11 you must buy an additional software package. The cost was in the thousands of dollars and validation was extra. Has anyone found a more economical solution?
 
chris1price

chris1price

Trusted Information Resource
#5
#5
You are correct, the part 11 version of DocuSign is an extra cost. We have just moved to AdobeSign, however I don't know the cost of part 11 compliance.
 
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