E-signatures for QMS?

[asantcom]

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?

 

[Sidney Vianna]

scroll down and see several previous similar threads.

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[Mustapha]

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.

 

[Chrisx]

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]

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.