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21 CRF Part 11 Compliance - Adobe Pro X vs Adobe Pro DC

New Here ,
May 07, 2021 May 07, 2021

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Hello Community:

 

1st, I have reached out to the online chat support and received multiple, different and conflicting responses.  I searched the community and online forms and web searches too and have come up with the same outcome, including replys to these searchs informing other users to search for their answers.  So I want to be clear, I have search and tried to do my homework but am not getting the result / answer / proof that I am looking for.  I am looking for a straight answer (no BS comment or wise crack reply) with supporting evidence.

 

2nd, I am currently using Adobe Pro X with a password enabled signature, a statement "Reason: I attest to the accuracy and integrity of this document" and date & time stamp.  If you click on my signature Adobe then provides additional information regaridng the legality of the signature and confirmation that the document has not been altered since the signature was place.

 

I work in the Pharma industry that complies to FDA (Food and Drug Admin) 21 CRF Part 11 for signatures and from what I have in place, believe to be compliant.  However, I am told by some companies I work for that it is, while other state it is not (conflict #1).  I am also being informed that Adobe Pro DC with AdobeSign is 21 CRF Part 11 complaince and should consider upgrading.  However, in chatting with online support some say yes, while other agents say no (conflict #2).

 

3rd, So here are my question as chatting with support and researching online resulted in inconclusive outcomes.

* Is my current version of Adobe Pro X 21 CRF Part 11 compliant?  If not, is there anything I can do to make it compliant?

 

* If my version is not complaint and cannot be modified, is Adobe Pro DC compliant?  If not, what will make it compliant?  If it is, which version as it appears there are individual, business, enterprise plans.

 

* How or what is AdobeSign and is that 21 CRF Part 11 compliant?

 

* Is AdobeSign an indepenant program?  If so, can I purchase that and incorportate it with Adobe Pro X (my current version)?

 

Thank you.

TOPICS
General troubleshooting, How to, Security digital signatures and esignatures

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LEGEND ,
May 07, 2021 May 07, 2021

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We can be sure Adobe support won't help with Acrobat X.

I don't like the sound of " I click on the signature...". Are you looking in the signature panel? 

What type of signature is it? Was it issued by a certifying authority?

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New Here ,
May 07, 2021 May 07, 2021

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Hi there

 

Thank you for the confirmation about lack of Acrobat X support.

 

As for the comment, apologies for not being clearer.  In Acrobat X, I click on tools, sign & certify, place signature.  This allows me to enter a signature on the document after i type in my password and select reason for the signature.  Once its is saved and you later go in to view the document, if you either click on the signature itself or the "signature" button on the right hand side, it brings up the validation pop-up window stating the signagture is valid and has a few options such as legal notice and signature properties for viewing.

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LEGEND ,
May 07, 2021 May 07, 2021

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In https://www.cognidox.com/blog/what-is-fda-21-cfr-part-11 I read "Part 11 reminds us of their specific definition, (one that sets them apart from other kinds of e-signature), where a recognised Certification Authority acts as a notary to verify the identity of a signer."

 

This is where I asked the question: "What type of signature is it? Was it issued by a certifying authority?" especially the second part. It seems clear that it MUST be issued by a certifying authority, and therefore a self-sign certificate won't do. Which would be just as well, as anyone in the world could create a self-sign certificate with your name on it.

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New Here ,
May 07, 2021 May 07, 2021

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When I set up my Digital ID in Acrobat X went through the steps for certification.  Now go into Tools, Sign & Certify, More Sign & Certify, Manage Trusted Identites and it shows "Certum QTSA".  However when I go to a document I signed, and check its validity, I can now see that this is a "self-sign cerificate".  Which is not acceptable.  I did find an article (https://www.adobepress.com/articles/article.asp?p=1708161&seqNum=4) that looks like i can import from a 3rd party (VeriSign or Entrust).  Would this then make the signature valid for "Part 11"?  If this still does not, then how does AdobeSign differ?

 

Oh and thank you for providing the information you did and confirming once and for all Acrobat X self-sign signature is not acceptable.

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