Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign? 

Thanks

Yes. They will accept any electronic signature method that requires the signer to authenticate the signature in some way. I personally use the certificate-based signature module in Adobe Acrobat DC.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States
------------------------------

Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

So do I. The beauty of using Adobe certification system is it locks the document and no one can modify/tamper with it. HC, EMA along with FDA encourage submitters using similar systems.

------------------------------
[Robert] [Falcone]
------------------------------

Original Message:
Sent: 23-Apr-2021 08:01
From: Glen Park
Subject: Does FDA accept documents signed by Docusign?

Yes. They will accept any electronic signature method that requires the signer to authenticate the signature in some way. I personally use the certificate-based signature module in Adobe Acrobat DC.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States

Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

Very interesting! How have you handled the Part 11 compliance?

------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy
------------------------------

Original Message:
Sent: 23-Apr-2021 08:01
From: Glen Park
Subject: Does FDA accept documents signed by Docusign?

Yes. They will accept any electronic signature method that requires the signer to authenticate the signature in some way. I personally use the certificate-based signature module in Adobe Acrobat DC.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States

Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

Hello,

DocuSign is a 21 CFR Part 11 compliant system that meets FDA requirements. FDA 21 CFR Part 11 regulation (Part 11) covers document signing and records retention for processes and documents specified by the FDA. 
Youmna

------------------------------
Youmna Abboud
Zimmer Biomet - ENTERPRISE
Beirut
Lebanon
------------------------------

Original Message:
Sent: 29-Apr-2021 03:59
From: Andrea Duca
Subject: Does FDA accept documents signed by Docusign?

Very interesting! How have you handled the Part 11 compliance?

------------------------------
Andrea Duca
COSMED Srl
Albano Laziale
Italy

Original Message:
Sent: 23-Apr-2021 08:01
From: Glen Park
Subject: Does FDA accept documents signed by Docusign?

Yes. They will accept any electronic signature method that requires the signer to authenticate the signature in some way. I personally use the certificate-based signature module in Adobe Acrobat DC.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States

Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

They do have a Part 11 compliant add-on to their Enterprise Pro module.

------------------------------
Howard Yorek
Senior Director, Regulatory Affairs
Norcross GA
United States
------------------------------

Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

This message was posted by a user wishing to remain anonymous

Recommend to use Part 11 compliant module of DocuSign which can authenticate the signature with certificate.  
Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

This message was posted by a user wishing to remain anonymous

I have hesitated to submit Docusigned documents as I thought FDA (at least the drug electronic submission gateway) doesn't accept secured / locked documents. Hopefully someone can enlighten me on this?
Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

If you are thinking of PDF security statements in FDA Guidance, those rules (Do not activate security settings or password protection) apply to review documents and not to signed documents such as cover letters and forms. Note that FDA forms such as 1571 and 356h already have their own security settings, so it is not that they can't accept secured/locked documents.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States
------------------------------

Original Message:
Sent: 24-Apr-2021 10:50
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

I have hesitated to submit Docusigned documents as I thought FDA (at least the drug electronic submission gateway) doesn't accept secured / locked documents. Hopefully someone can enlighten me on this?
Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

This message was posted by a user wishing to remain anonymous

Glen,

Thanks for your reply.

I checked the security settings in Acrobat of on one of the DocuSigned documents (a description of the device used to deliver the drug, so not a form). The document has the following:

• The Security Method says "No Security."

• The Document Restrictions Summary has everything Allowed EXCEPT:

• • Change the Document - Not Allowed
  • Document Assembly - Not Allowed

QUESTION: Will this document be accepted through FDA's Electronic Submission Gateway (for a drug submission)?

Original Message:
Sent: 26-Apr-2021 16:47
From: Glen Park
Subject: Does FDA accept documents signed by Docusign?

If you are thinking of PDF security statements in FDA Guidance, those rules (Do not activate security settings or password protection) apply to review documents and not to signed documents such as cover letters and forms. Note that FDA forms such as 1571 and 356h already have their own security settings, so it is not that they can't accept secured/locked documents.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States

Original Message:
Sent: 24-Apr-2021 10:50
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

I have hesitated to submit Docusigned documents as I thought FDA (at least the drug electronic submission gateway) doesn't accept secured / locked documents. Hopefully someone can enlighten me on this?
Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks

Yes. Those restrictions are also present on Acrobat-signed documents and they are accepted.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States
------------------------------

Original Message:
Sent: 27-Apr-2021 07:51
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Glen,

Thanks for your reply.

I checked the security settings in Acrobat of on one of the DocuSigned documents (a description of the device used to deliver the drug, so not a form). The document has the following:

• The Security Method says "No Security."

• The Document Restrictions Summary has everything Allowed EXCEPT:

• • Change the Document - Not Allowed
  • Document Assembly - Not Allowed

QUESTION: Will this document be accepted through FDA's Electronic Submission Gateway (for a drug submission)?

Original Message:
Sent: 26-Apr-2021 16:47
From: Glen Park
Subject: Does FDA accept documents signed by Docusign?

If you are thinking of PDF security statements in FDA Guidance, those rules (Do not activate security settings or password protection) apply to review documents and not to signed documents such as cover letters and forms. Note that FDA forms such as 1571 and 356h already have their own security settings, so it is not that they can't accept secured/locked documents.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States

Original Message:
Sent: 24-Apr-2021 10:50
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

I have hesitated to submit Docusigned documents as I thought FDA (at least the drug electronic submission gateway) doesn't accept secured / locked documents. Hopefully someone can enlighten me on this?
Original Message:
Sent: 22-Apr-2021 03:30
From: Anonymous Member
Subject: Does FDA accept documents signed by Docusign?

This message was posted by a user wishing to remain anonymous

Hi,

According to the FDA announcement on the Digital/Electronic Signatures, Docusign belongs to the Flatten digital signatures. Does anyone have experience, whether FDA accepted 510k submission signed by Docusign?

Thanks