Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all,
I have to ensure our program complies with Part 11 for electronic signatures. Could you please help me with some advise. In your experience, what kind of program is better to meet compliance with  21 CRF Part 11 Docusign or Adobesign? Also, do I need to perform any in house validation or the programs come with a validation package?
Thank you all for your help with this inquiry.

Hello RAPS member,

21 CFR Part 11 mandates that life science organizations using electronic signatures meet three distinct categories of compliance requirements:

• Security for "closed systems" (Subpart B sec 11.10)
• Security for "Open systems" (Subpart B sec 11.30)
• Requirements for executing an electronic signature (Subpart B sec 11.50 and sec 11.70; Subpart C)

Under 21CFR Part 11, a "System" is described as either closed or open. A closed system is an environment in which system access is controlled by the individuals who are responsible for the content of the electronic records that are in the system. Conversely, an open system is an environment in which system access is not controlled by individuals who are responsible for the content of electronic records that are in the system.
Adobe sign is generally considered to be an open system; One can create a closed system with a single user (QA/RA or Document control ) responsible for the routing of documents and responsible for the content of the electronic records. 

Attached is the compliance document from Adobe. You can use this document as a starting point.
I would strongly recommend you to perform a risk assessment and then validate the requirements of a closed or open system.

Hope this helps!

Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------

Original Message:
Sent: 11-Jul-2020 15:06
From: Anonymous Member
Subject: Adobe program compliant with Part 11

This message was posted by a user wishing to remain anonymous

Dear all,
I have to ensure our program complies with Part 11 for electronic signatures. Could you please help me with some advise. In your experience, what kind of program is better to meet compliance with  21 CRF Part 11 Docusign or Adobesign? Also, do I need to perform any in house validation or the programs come with a validation package?
Thank you all for your help with this inquiry.

This message was posted by a user wishing to remain anonymous

Thank you very much for your feedback and the resources that you provided in your response. It is very helpful for my project!
Original Message:
Sent: 14-Jul-2020 02:41
From: Soumya Rajesh
Subject: Adobe program compliant with Part 11

Hello RAPS member,

21 CFR Part 11 mandates that life science organizations using electronic signatures meet three distinct categories of compliance requirements:

• Security for "closed systems" (Subpart B sec 11.10)
• Security for "Open systems" (Subpart B sec 11.30)
• Requirements for executing an electronic signature (Subpart B sec 11.50 and sec 11.70; Subpart C)

Under 21CFR Part 11, a "System" is described as either closed or open. A closed system is an environment in which system access is controlled by the individuals who are responsible for the content of the electronic records that are in the system. Conversely, an open system is an environment in which system access is not controlled by individuals who are responsible for the content of electronic records that are in the system.
Adobe sign is generally considered to be an open system; One can create a closed system with a single user (QA/RA or Document control ) responsible for the routing of documents and responsible for the content of the electronic records.

Attached is the compliance document from Adobe. You can use this document as a starting point.
I would strongly recommend you to perform a risk assessment and then validate the requirements of a closed or open system.

Hope this helps!

Regards,

------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands

Original Message:
Sent: 11-Jul-2020 15:06
From: Anonymous Member
Subject: Adobe program compliant with Part 11

This message was posted by a user wishing to remain anonymous

Dear all,
I have to ensure our program complies with Part 11 for electronic signatures. Could you please help me with some advise. In your experience, what kind of program is better to meet compliance with  21 CRF Part 11 Docusign or Adobesign? Also, do I need to perform any in house validation or the programs come with a validation package?
Thank you all for your help with this inquiry.

Hello

You should always perform an internal validation

For AdobeSign, Adobe offers in this some help: https://helpx.adobe.com/sign/using/21-cfr-validation-pack.html

https://adobe.lookbookhq.com/sign-recommend/adobe-sign-complianc

Greetings,
Franky

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 11-Jul-2020 15:06
From: Anonymous Member
Subject: Adobe program compliant with Part 11

This message was posted by a user wishing to remain anonymous

Dear all,
I have to ensure our program complies with Part 11 for electronic signatures. Could you please help me with some advise. In your experience, what kind of program is better to meet compliance with  21 CRF Part 11 Docusign or Adobesign? Also, do I need to perform any in house validation or the programs come with a validation package?
Thank you all for your help with this inquiry.

I would second Franky's statement you need to validate Adobe electronic signatures internally - they do not offer a "validated" program or 21 CFR Part 11 compliant program.  You would have to use their information or other sources of information to validate the program itself and implement other controls for 21 CF Part 11 compliance.  Most electronic signatory systems out there are "open" systems as Soumya described, so much of the reponsibility for validation will be the manufacturer/company responsibility.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Jul-2020 02:46
From: Franky Dubois
Subject: Adobe program compliant with Part 11

Hello

You should always perform an internal validation

For AdobeSign, Adobe offers in this some help: https://helpx.adobe.com/sign/using/21-cfr-validation-pack.html

https://adobe.lookbookhq.com/sign-recommend/adobe-sign-complianc

Greetings,
Franky

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 11-Jul-2020 15:06
From: Anonymous Member
Subject: Adobe program compliant with Part 11

This message was posted by a user wishing to remain anonymous

Dear all,
I have to ensure our program complies with Part 11 for electronic signatures. Could you please help me with some advise. In your experience, what kind of program is better to meet compliance with  21 CRF Part 11 Docusign or Adobesign? Also, do I need to perform any in house validation or the programs come with a validation package?
Thank you all for your help with this inquiry.

This message was posted by a user wishing to remain anonymous

Thank you all for your feedback and the resources provided!
Original Message:
Sent: 11-Jul-2020 15:06
From: Anonymous Member
Subject: Adobe program compliant with Part 11

This message was posted by a user wishing to remain anonymous

Dear all,
I have to ensure our program complies with Part 11 for electronic signatures. Could you please help me with some advise. In your experience, what kind of program is better to meet compliance with  21 CRF Part 11 Docusign or Adobesign? Also, do I need to perform any in house validation or the programs come with a validation package?
Thank you all for your help with this inquiry.

This message was posted by a user wishing to remain anonymous

Good day All,

DocuSign has been selected by my current employer for e-signature routing. My employer has performed risk assessments against AdobeSign and DocuSign systems, and has selected subscription to DocuSign for Part 11 compliance and non-regulated documentation. As a large biotech CRO, my employer utilizes the Part 11 subscription for the bulk documentation needs. Please keep in mind there are different types of DocuSign subscriptions, including options that are not Part 11 compliant.

I, myself, have had the opportunity to sign via Docusign and the general signing options in Adobe Pro (not AdobeSign) for USDA regulatory documentation. The USDA's submission Portals easily accepts e-signatures from the general Adobe Pro since their access to their Portals require eAuthentication prior to document submission. I am unaware if other regulatory agencies act in the same way. The USDA Portals have found difficulty marrying DocuSign-ed submissions for file compilation. As much as the DocuSign-ed article is preferred by my firm's QA department and for our GMP activities, there have been hiccups with regulatory agencies to view and manage our DocuSigned submissions. Also, bare in mind that to be Part 11 compliant, firms must decide how to download and manage the electronic "envelopes" (documents for signature) from the DocuSign cloud server onto their own restricted e-repositories for the life of the document and for archiving. Something to think about additionally beyond the core task of routing signatures.

I hope this helps. For more information, I suggest reviewing a few courses at the DocuSign University. https://dsu.docebosaas.com/customers/learn?_ga=2.219652697.1564722331.1570543763-1132082898.1570543763
Original Message:
Sent: 11-Jul-2020 15:06
From: Anonymous Member
Subject: Adobe program compliant with Part 11

This message was posted by a user wishing to remain anonymous

Dear all,
I have to ensure our program complies with Part 11 for electronic signatures. Could you please help me with some advise. In your experience, what kind of program is better to meet compliance with  21 CRF Part 11 Docusign or Adobesign? Also, do I need to perform any in house validation or the programs come with a validation package?
Thank you all for your help with this inquiry.