Adobe Acrobat: self signed digital signature and FDA.

[thibb2]

Hello, 

I would like to know if  when I create a digital signature with a self signed certificate in Adobe Acrobat Reader DC it is compliant with the FDA regulation. I am confused about all of this. I saw that Adobe Sign is compliant with the FDA but it seems the signing options are the same in Adobe acrobat reader (free version). 

What is the difference between both solutions? 

[ls_rbls]

The electronic and digital signing are all compliant accross different platforms.

The different products and services, and what each can do or not, is what is different.

For instance, Adobe Reader DC is a free version available for Windows and macOS that allows you to view, fill, sign, print, comment, save  and share PDFs in a very convenient way.

Adobe Sign is an integration that complements the signing, sharing  and collaboration workflow between one or two more parties.

It also facilitates the ability to publish a PDF online as a webform, so that users can go amd download themseleves, for example.

This eliminates the need of sending emails and attachments all the time and the, sometimes tedius and burdersome, reviewing process of agreements.

That is just  a few of the many cool things  about Adobe Sign.

[thibb2]

Hello ls_rbls, 

Thank you for your quick reply.

I understand the difference between Acrobat (the software) and

Adobe sign (cloud solution) which is useful for managing the sharing/sending ways.

But in term of compliance with signature, are they the same? In my company we tried to implement a quality management system and we have to be compliant with FDA regulation.We have the idea to use Self signed certificate to make digital signatures ( so we don't buy certificates to certificate authority) with Acrobat option when you create a digital ID. But I can't find any documentation about Adobe Acrobat certification. So I don't know if the signatures will be compliant like this. 

Adobe Sign says it is cfr21 part 11 certified but I don't see any difference with the signatures option in Adobe Acrobat. They can both make signature with text, picture, drawing and digital signature. So if I use Adobe Sign it doesn't matter which kind of signature I use? It will always be compliant? 

So is Adobe Acrobat also cfr21 part11 certified like Adobe Sign? Because to be honest, if I am compliant with cfr21 when I make a signature in Acrobat, I don't see why I will pay for an Adobe Sign license.   

  Or is there a difference that makes Adobe Sign only cfr11 certified? 

Kind regards  

[ls_rbls]

Good question. 

I answered this for two users a while ago.

The detail is that the new revamped  Adobe Sign actually supports the CFR21 Part11 compliance and so does Acrobat Pro DC.

However, using Acrobat alone in a workflow like in your case, it won't support this workflow if, for example, your self-signed certificates depend on more than one time-stamp server. 

Adobe Acrobat Pro can handle this part but it will always get the time stamp from  the default time-stamping server. 

With Adobe Sign you get to configure more than one time-stamping server and give the users the ability to choose   certificates with different identities that may reuire a different time-stamp server, other than the default.

According to one CFR that I read from FDA, the electronic documents and workflowm varies from country to country. So that said, this ability to use more than one time-stamp server with Adobe Sign was crafted to support other regulatory agencies, like in the case of countries in Europe for example. 

Moreover, the issue is not on the Adobe side of the house, but in the FDA regulations and policies that define these workflow.  They're all the time under revision, and in some instances they can't be so stringent.

If you give me some more time I will get you the discussion where I sorted out all of this infomration.

[ls_rbls]

Here's the discussion I was telling you about:

• Digital Signature - 21 CFR part 11 compliance