Document Control Question involving DocuSign


We are a small startup and cant afford software for document control but want to use DocuSign to approve changes, CAPAs, Deviations, Training forms, etc. Is there anyone else out there doing this and what problems, if any, did you have? I assume I need to use the Part 11 compliance module or I would be in trouble.


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I've previously worked for a company that subscribed to Docusign; we had products that were 510(k) registered and I was told that one reason we used Docusign was because it was recognised by the FDA as complying with their requirements.

FWIW it has the option of signatures having to be given in a specific order, or the document can go simultaneously to required signatories where the signing order is not important


I've been using DocuSign for several years. I use it for anything requiring approval in our QMS. Our IT Department did perform a IQ/OQ and validation as it relates to our using the software. We've been through several Registrar audits and one FDA audit while using the software and have had no issues. The part 11 module would be required. We've experienced no issues in using the software


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I have not used Docusign internally (for any reason, including QMS or regulatory), but we have used it with some of our external partners... essentially for contractual purposes. As we were using it for ad hoc reasons, there were a handful of annoying aspects to it relating to permissions and access, but if the internal IT group is committed to seeing it work (i.e. validated) this shouldn't be an issue.


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I've been using Docusign for several years now with different companies. No issues using it.
I like it because it's flexible and relatively inexpensive. Validation is pretty simple too.


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Like others, I have been using DocuSign for years and had no problems. Note, there are different versions, you need the Part 11 Module to be compliant.
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