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Adobe Sign as digital signature tool

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Luca Ercolani, Jun 8, 2020.

  1. Luca Ercolani

    Luca Ercolani New Member

    Jun 8, 2020
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    Hi all,

    This is my first post here, so I apologize if this is the wrong section.

    I'm building a Quality Management System for a young European company looking to become ISO 13485 certified. Their CEO and COO (only functions that can review and approve document for now and the foreseeable future) reside in China and the Company's headquarters are in Ireland, so approval of documents has to be in electronic format to streamline the process as much as possible (only exception would be the declaration of conformity)

    I'm considering Adobe Sign as a digital signature tool for them. Do you have any experience working with it? Some additional information below after I fooled around with a trial account:

    - Document issuer can digitally sign the document from his/her account and send the document to reviewer and approver.
    - Document reviewer gets the email notification first. After reviewer signs, the document is automatically sent to the approver. Approver cannot sign before reviewer, as no notification is displayed before reviewer has signed.
    - If someone tries to access a document from another person's account, a message is displayed that the document cannot be opened, and they should sign in with their account.
    - It is possible to set a password to access each document. The password can be chosen by the issuer and communicated separately to reviewer and approver only.
    - Documents cannot be modified once signed, not even with Adobe Pro (tried that as well).

    Thank you in advance, looking forward to your feedback!

  2. yodon

    yodon Well-Known Member

    Aug 3, 2015
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    13485 doesn't really touch on electronic signatures so there's nothing really driving what / how you do it. On the drug side in the EU, there's Annex 11 for computerized systems that gets a little more in depth on signatures but since it's for drugs, you may want to discount it.

    Generally speaking, if you show that you're controlling document approval and you manage e-signature integrity, you should probably be ok. You may want to give 21 CFR Part 11 (the FDA regulation for e-records and e-signatures) a read. While it clearly has some issues, there are some good fundamentals there that if you can follow, you can best demonstrate control. You'd probably improve your position anyway if you validate (documented) the process you describe.
    Steven Severt likes this.
  3. Steven Severt

    Steven Severt Member

    Jun 6, 2018
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    I was going to mention Part 11; like you mentioned, ISO 13485 doesn't really touch on electronic signatures and doesn't have any extraordinary requirements for document approval and control. I know a lot of people freak out after reading the requirements of Part 11, and the FDA has issued subsequent guidance documents to help reduce concerns and clarify parts that are difficult. In my experience, like you mentioned, as long as you can demonstrate control of your document origination and approval, and the signatures are traceable back to the signer, the FDA is typically good with whatever system is used. We've used PandaDocs, which is very similar to Adobe Sign, with no problems at all.
    Sheila Engfer likes this.