Document Signature Software? (Certificate Authorities)

pkost

Trusted Information Resource
#11
Hello Joanne and Marc,

I just got off the LiveChat with the Adobe Sales Rep. He confirmed their only product that is 21CFR Part11 compliant is AdobeSign Enterprise. AdobePro would not be compliant. You have to buy a separate product AdobeSign Enterprise.
Adobe Sign Enterprise is pretty much 21 CFR 11 compliant out of the box, in my opinion it is the best solution out there at the moment in terms of ease and security. It is fully integrated into acrobat reader which everyone knows. It is however obscenely expensive

I would argue that it is wrong to say that adobe acrobat/reader is not compliant as it is not getting to the crux of the matter - it is the PKI infrastructure that is implemented and how that is controlled that makes the system compliant and has little to do with adobe acrobat. It is like asking someone if a piece of paper is acceptable to sign on
 
Elsmar Forum Sponsor
#12
Does anyone have a preferred digital signature solution for your document approval process? I want to get one installed to I can start having our team apply valid digital signatures to documents. The current process of just adding the signature line in MS Word still returns an error indicating that the signature was not verified.
Hi, I know this may be late but I am new to this forum. I work for a medical device manufacturing company and we use software called DocuSign. It is Part 11 compliant and really easy to use.
 

ISO_Man

Involved In Discussions
#13
Thanks - we don't need 21 CFR Part 11 (at least not yet) so I've been using SignRequest which is easy to use and MUCH cheaper than DocuSign.
 
#14
Dear All,
I was looking into this discussion but I'm still unclear about the following:
Our company is using Adobe Acrobat Reader DC. This package allows for signing documents with digital ID. I am now wondering if there's a difference with AdobeSign? This this a separate functionality? And is there a difference in 21 CFR part 11 compliance between AdobeSign and what we're currently doing?
Many thanks,
Bert
 

pkost

Trusted Information Resource
#15
In order to sign a document electronically you need a cryptographic certificate which securely embeds your details (signature) into the document ; the certificates are easy to make, (you can make your own through adobe or windows). If you create your own certificate you can provide any name, any email, any company details - whatever you want, you can have multiple certificates all with different identities, you could even create a new certificate for each signature. Therefore why would I trust it?Why would the FDA trust it?

Adobe reader allows you to use any certificate to sign the document, but that does not necessarily give any trust. AdobeSign provides the infrastructure that enables me to trust that you actually signed the document you have given me

If you want to delve into the detail of it, take a look at Public Key Infrastructure (PKI). AdobeSign provides a number of other features, but it is this aspect that enables the 21CFR11 compliance
 
#16
Thanks a lot for your feedback. One follow-up question though: If we want to start using AdobeSign what type of 'validation' activities do we need to perform to 'approve' this system? Although AdobeSign states to be 21 CFR part 11 compliant, I believe it's our responsibility to check and verify this?
 
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