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Bert Peeters
Participant
January 31, 2020
Answered

Digital Signature - 21 CFR part 11 compliance

  • January 31, 2020
  • 2 replies
  • 14094 views

Hi All,
I'm also curious to know the difference between Adobe Sign and the free option in Adobe Reader to apply digital ID (certificates) in the light of 21 CFR part 11 compliance. Does the latter option allow for 21 cfr part 11 compliance? I'm really struggling with this. Most of the information I find linked to this is for AdobeSign.
Many thanks in advance,
Bert

This topic has been closed for replies.
Correct answer Skye29625825cy2k

from my understanding, i tis not part 11 compliant unless the system is validated as such. we went with the 21 cfr part 11 adobe sign e-signatures and validated the system for 21 cfr part 11 compliance.

2 replies

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Skye29625825cy2k
Participant
April 27, 2023

Hi Bert,

Did you find a solution for this question? I am also wondering the same.

    S
    saskiab52245447
    Participant
    December 4, 2024

    Hi Bert, Skye,

     

    Did either of you figure this out? I am also wondering if we are able to use the free version Adobe reader version for part 11 compliance. Thank you. 

    S
    Skye29625825cy2kCorrect answer
    Participant
    December 4, 2024

    from my understanding, i tis not part 11 compliant unless the system is validated as such. we went with the 21 cfr part 11 adobe sign e-signatures and validated the system for 21 cfr part 11 compliance.

      ls_rbls
      Community Expert
      ls_rblsCommunity Expert
      Community Expert
      February 7, 2020

      Hi,

       

      You need to download and read this document : https://helpx.adobe.com/sign/kb/Is-Adobe-Sign-21-CFR-Part-11-Compliant.html

       

      See also other information here: https://www.adobe.com/content/dam/acom/en/security/pdfs/adobe-sign-compliance-21CFRpt11-wp-ue.pdf

       

      https://www.techrepublic.com/article/adobe-makes-e-signature-tool-healthcare-compliant-adds-sap-integration/

      B
      Bert PeetersAuthor
      Participant
      February 7, 2020

      Thanks a lot! I've found most of these references as well. My main question is: Adobe Reader also has a standard option (for free) to certify documents with a digital signature. However, does this offer to same features and level of compliance then AdobeSign, i.e. is there any added value to subscribe and pay for AdobeSign. We're working in a regulated environment so compliance is key.
      Many thanks,
      Bert

      S
      svulinec
      Participating Frequently
      April 14, 2020

      Well, that is because Adobe Sign is the engine that enforces the security mechanisms and standards of E-sign when electronic signatures are applied in such workflow.

       

      This is different from just sending a document or downloading government forms, in which individuals just apply any type of electronic signature.

       

       

      When you create a form, you'll notice that when you click on the Fill &Sign tool it will switch and interface with Adobe Sign before you send this form out to collect electronic signature from your intended recipients.

       

      But, Please define what you meant by FDA. 

       

      Are we talking about the Food and Drug Administration or something else?

       

      If this has to do with a government agency and gow they use their and distribute their own PDFs forms you'll have to do your own homework there because that doesn't necessarily mean these PDFs were created with Adobe products.

       

      In the meanwhile, I am going to find an old thread where I answered this question for another user.

       

      I posted there the references that you're inquiring about that deals with the Adobe Acrobat side of the house


      Thanks so much for the communication back and the information. Yes, i am looking into some of the Food and Drug Administrations approved electronic signatures they allow for institutions to be compliant with them.

      I know AdobeSign the application is compliant. I am avoiding the E Sign Application, because once you sign, it locks the docuemnt and i cannot edit it after the signature goes in place. I was trying to research and decipher if when creating an Adobe document, using the "prepare" field and adding a "digital Signature" for a user, if that would also be compliant in their regulations, but couldn't seem to find the language. But now, I see that I may need to research "e-signature" vs. "digital signature" as I have seen other threads that they may not be the same thing. I guess it just takes some digging. Thanks again for the reply, you were very helpful!

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