Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

Adobe used to have a nice electronic signature of documents.  Now, the person has to request a signature instead of just being able to e-sign a document.  Older versions of Reader allowed this, but the new DC with everything online it must be requested.  There are other methods too such as e-approval through email program add-ons.  Then of course there are electronic approval suites some free with limited availability and others with full capability, but those are pricey.  Personally, sticking a scanned picture of my signature on a Word document and then printing to PDF still seems to work fine !

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

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

I use the desktop version of Adobe DC and sign electronically as a Part 11 compliant process. The point of a signature is that it is, or should be, a statement by the signer that they are taking responsibility for the document. I could make a copy of anyone's signature and paste it on a document. In fact, this posting is approved by Donald Trump.



------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 22-Mar-2020 14:24
From: Richard Vincins
Subject: Temporary solution for hard copy signatures

Adobe used to have a nice electronic signature of documents.  Now, the person has to request a signature instead of just being able to e-sign a document.  Older versions of Reader allowed this, but the new DC with everything online it must be requested.  There are other methods too such as e-approval through email program add-ons.  Then of course there are electronic approval suites some free with limited availability and others with full capability, but those are pricey.  Personally, sticking a scanned picture of my signature on a Word document and then printing to PDF still seems to work fine !

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

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

I used to work for  small company that still used paper documentation. We had several people that worked remote, and when we needed a signature, we would scan the the signature form and email it to them. They would print it, sign it, and then scan the form back to us. We would print out the signed form, and keep it for the file. The remote person would then send the actual wet signature forms to us on a regular basis, for the files.
It's cumbersome, but it works.

------------------------------
Susan Shockey RAC
Principal Consultant
Mt Pleasant SC
United States
------------------------------

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

We have been allowing clients to take a photo of their signature and send it over email/text. Once everything is back to "normal" they will send either the original or scan where appropriate.​

------------------------------
Alicia Whittlesey
Counsel and Director of Compliance Services at Porzio Bromberg & Newman P.C.
Westborough MA
United States
------------------------------

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

This message was posted by a user wishing to remain anonymous

Hi -

I was going to post this exact same question!  Please if anyone has any information I would appreciate it as well.  Is a locked password protected pdf signature ok?  How should this be addressed in our SOPs?

Thank you!
Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

This message was posted by a user wishing to remain anonymous

At my last company we were not FDA Part 11 compliant.  We used Adobe (Pro or Reader) to electronically sign everything and stored the documents as PDF.  At least two FDA inspections and more ISO audits then I care to think about and no questions asked.  Adobe claims Part 11 compliance and is easy to use.
Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

This message was posted by a user wishing to remain anonymous

Use docusign. Allows embedding electronic signature S into documents. The send docs thru email.
Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

Hi,

I'm currently working remotely and I'm using Adobe pro to sign any document electronically, or you may use the old fashioned way. You can print the document, sign, scan then send it back to the sender.

------------------------------
Dina Badawy, Msc
Regulatory Affairs Specilaist
Cairo
Egypt
------------------------------

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

We are handling this issue in a number of ways depending on the area of concern, ranging from the use of DocuSign, to scanned photos, as well as the temporary acceptance of e:mail acknowledgements.  We are documenting the departure from our standard processes as "deviations" within our QMS for this period of time.​

------------------------------
[Whitney] [Davis]
[Quality Specialist III]
[Instrument and Enterprise Services]
[Thermofisher Scientific]
[Marietta] [OH]
[USA]
------------------------------

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

Hi!
I've run into this before and here's what I came up with:

- For client/external signatures I use SignNow, which is super intuitive and user friendly. You can get three signatures per month for free.

- For clients who need an affordable e-signature solution for their team (where there are often many documents to sign per month by just a handful of people), I recommend using Adobe Reader. It's free and offers functionality that enable compliance with part 11 (although full compliance with part 11 obviously requires additional policies/procedures/controls). Once clients are up and running with this, they usually find it is much faster and easier than the print/sign/scan routine.

I'm attaching a tutorial document and am working on getting a tutorial video up soon. 

Hope this is helpful!



------------------------------
Aimee Feuser
Trestlework, LLC
Chicago, IL
------------------------------

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

Hi Aimee,

Thank you for putting together the tutorial! Very helpful! I tested it and it works. What I also found out however is that I can create an electronic signature for whoever I want and sign, Have you found a work around for that? How do you ensure that the person actually signed and somebody else did not create a signature for them and signed?

------------------------------
Virginia Anastassova RAC
RA Manager, Senior QA Specialist
Victoria BC
Canada
------------------------------

Original Message:
Sent: 24-Mar-2020 12:02
From: Aimee Feuser
Subject: Temporary solution for hard copy signatures

Hi!
I've run into this before and here's what I came up with:

- For client/external signatures I use SignNow, which is super intuitive and user friendly. You can get three signatures per month for free.

- For clients who need an affordable e-signature solution for their team (where there are often many documents to sign per month by just a handful of people), I recommend using Adobe Reader. It's free and offers functionality that enable compliance with part 11 (although full compliance with part 11 obviously requires additional policies/procedures/controls). Once clients are up and running with this, they usually find it is much faster and easier than the print/sign/scan routine.

I'm attaching a tutorial document and am working on getting a tutorial video up soon.

Hope this is helpful!



------------------------------
Aimee Feuser
Trestlework, LLC
Chicago, IL

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

Hi Virginia,
 Great question. Thanks for bringing it up. This gets at the parts of Part 11 compliance that relies upon the associated control procedures surrounding the use of e-signature software (I included the applicable text from part 11 below). Basically, it is up to each company to have sufficient documented controls to ensure that each of their employee's electronic signatures is verified and unique to them. Use of Adobe Reader alone is not enough to ensure this, as you have seen, so I would always recommend that it only be used in the context of a broader control process that takes these risks into account. I would recommend incorporating trusted identities into that process. Here is some info on using and managing trusted identities in Adobe, particularly the Adobe Approved Trust List (AATL) https://helpx.adobe.com/acrobat/using/trusted-identities.html.
I haven't used AATL myself, so I'll take some time soon to try it out. I'm guessing there will need to be some changes to my tutorial to incorporate this change. I'd love further feedback if you have it!

§11.100   General requirements.

(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.

(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.

------------------------------
Aimee Feuser
Trestlework, LLC
Chicago, IL
------------------------------

Original Message:
Sent: 26-Mar-2020 13:37
From: Virginia Anastassova
Subject: Temporary solution for hard copy signatures

Hi Aimee,

Thank you for putting together the tutorial! Very helpful! I tested it and it works. What I also found out however is that I can create an electronic signature for whoever I want and sign, Have you found a work around for that? How do you ensure that the person actually signed and somebody else did not create a signature for them and signed?

------------------------------
Virginia Anastassova RAC
RA Manager, Senior QA Specialist
Victoria BC
Canada

Original Message:
Sent: 24-Mar-2020 12:02
From: Aimee Feuser
Subject: Temporary solution for hard copy signatures

Hi!
I've run into this before and here's what I came up with:

- For client/external signatures I use SignNow, which is super intuitive and user friendly. You can get three signatures per month for free.

- For clients who need an affordable e-signature solution for their team (where there are often many documents to sign per month by just a handful of people), I recommend using Adobe Reader. It's free and offers functionality that enable compliance with part 11 (although full compliance with part 11 obviously requires additional policies/procedures/controls). Once clients are up and running with this, they usually find it is much faster and easier than the print/sign/scan routine.

I'm attaching a tutorial document and am working on getting a tutorial video up soon.

Hope this is helpful!



------------------------------
Aimee Feuser
Trestlework, LLC
Chicago, IL

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.

Thank you, Aimee! I agree with you, the best way around this is to have a procedure in place on how to ensure signatures are authentic. You can get electronic signatures with certification from Adobe but I was told the cost is $20K. I am also checking SignNow for cost.

------------------------------
Virginia Anastassova RAC
RA Manager, Senior QA Specialist
Victoria BC
Canada
------------------------------

Original Message:
Sent: 26-Mar-2020 14:03
From: Aimee Feuser
Subject: Temporary solution for hard copy signatures

Hi Virginia,
 Great question. Thanks for bringing it up. This gets at the parts of Part 11 compliance that relies upon the associated control procedures surrounding the use of e-signature software (I included the applicable text from part 11 below). Basically, it is up to each company to have sufficient documented controls to ensure that each of their employee's electronic signatures is verified and unique to them. Use of Adobe Reader alone is not enough to ensure this, as you have seen, so I would always recommend that it only be used in the context of a broader control process that takes these risks into account. I would recommend incorporating trusted identities into that process. Here is some info on using and managing trusted identities in Adobe, particularly the Adobe Approved Trust List (AATL) https://helpx.adobe.com/acrobat/using/trusted-identities.html.
I haven't used AATL myself, so I'll take some time soon to try it out. I'm guessing there will need to be some changes to my tutorial to incorporate this change. I'd love further feedback if you have it!

@11.100   General requirements.

(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.

(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.

------------------------------
Aimee Feuser
Trestlework, LLC
Chicago, IL

Original Message:
Sent: 26-Mar-2020 13:37
From: Virginia Anastassova
Subject: Temporary solution for hard copy signatures

Hi Aimee,

Thank you for putting together the tutorial! Very helpful! I tested it and it works. What I also found out however is that I can create an electronic signature for whoever I want and sign, Have you found a work around for that? How do you ensure that the person actually signed and somebody else did not create a signature for them and signed?

------------------------------
Virginia Anastassova RAC
RA Manager, Senior QA Specialist
Victoria BC
Canada

Original Message:
Sent: 24-Mar-2020 12:02
From: Aimee Feuser
Subject: Temporary solution for hard copy signatures

Hi!
I've run into this before and here's what I came up with:

- For client/external signatures I use SignNow, which is super intuitive and user friendly. You can get three signatures per month for free.

- For clients who need an affordable e-signature solution for their team (where there are often many documents to sign per month by just a handful of people), I recommend using Adobe Reader. It's free and offers functionality that enable compliance with part 11 (although full compliance with part 11 obviously requires additional policies/procedures/controls). Once clients are up and running with this, they usually find it is much faster and easier than the print/sign/scan routine.

I'm attaching a tutorial document and am working on getting a tutorial video up soon.

Hope this is helpful!



------------------------------
Aimee Feuser
Trestlework, LLC
Chicago, IL

Original Message:
Sent: 20-Mar-2020 07:57
From: Anonymous Member
Subject: Temporary solution for hard copy signatures

This message was posted by a user wishing to remain anonymous

Hi All
In light of many people working from home now and in light of the fact that many small firms still use hand signed approvals, I would be interested in hearing of any creative solutions (scans, emails etc)  and to hear of people's views on the acceptability of these temporary approval methods in light of the extraordinary situations we are going through at the moment.