Skip to main content
B
Bert Peeters
Participant
January 31, 2020
Answered

Digital Signature - 21 CFR part 11 compliance

  • January 31, 2020
  • 2 replies
  • 14070 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

S
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

      ls_rbls
      Community Expert
      ls_rblsCommunity Expert
      Community Expert
      February 7, 2020

      Hi,

       

      Adobe Reader meets the same criteria.

       

      As a matter of fact, When compared with Adobe Acrobat Pro, its does provide the users with a more restrictive and tighter security.

        Terms & ConditionsAccessibility statement
        Using the community Terms of use Privacy Cookie preferences Do not sell or share my personal information ad choicesAdChoices