Regulatory Open Forum

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.   

Thanks.

------------------------------
Karen Zhou
------------------------------

Hi Karen,

I think it truly depends on how you are going to use and for what you are exactly using it. If you are looking for something for QMS, for such a small organization, I don't see a need to go with digital or electronic signature options rather follow the handwritten signature procedures.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
------------------------------

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

I use the SignNow app regularly. It involves the use of a marking instrument (a stylus in my case) to apply a signature to any document opened in the app. Using SignNow results in a PDF document that can be emailed or downloaded.

The SignNow signature is a HANDWRITTEN SIGNATURE as defined in 21 CFR Part 11, and therefore the ELECTRONIC SIGNATURE requirements in Part 11 do not apply. DocuSign may offer such an app but I am not sure. When most people are speaking about DocuSign they are speaking about their electronic signature service, for which Part 11 controls do apply. 
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HANDWRITTEN SIGNATURE (USA 21 CFR Part 11): The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

ELECTRONIC SIGNATURE (USA 21 CFR Part 11): A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

DIGITAL SIGNATURE (USA 21 CFR Part 11): An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

Source: ecfr.gov
---------------------------------------------------------------------------------------------------------------------------------------------------

Part 11 only applies to electronic signatures that are being made to ensure compliance when a signature requirement in another FDA regulation (i.e. a predicate rule). For example, 21 CFR Part 820 (device quality system regulation) only requires signatures for the specific documents/records listed below.

Signature requirements in FDA 21 CFR 820
820.30 Design controls (c) Design input
820.30 Design controls (d) Design output
820.40 Document controls.
820.75 Process validation
820.80 Receiving, in-process, and finished device acceptance
820.120 Device labeling (b) Labeling inspection
820.90 Nonconforming product (b) Nonconformity review and disposition

Signature requirements in ISO 13485:2016
None

------------------------------
Sam Lazzara
Principal Consultant
Fremont CA
United States
https://mdqc.blog/
------------------------------

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

Very timely topic for me as I'm trying to figure out a way to incorporate a solution for electronic signatures for our paper based QMS that would require little or no validation from a Part 11 perspective.  We're small company and still at least another 1-2 years from electronic QMS, but have people working remotely on a regulatory basis so timely document approval is a total time sucker and ineffecient.

Could we allow staff to scan their wet signature and use that jpeg file to virtually sign QS documents which would then be printed and the paper version filed as the official copy?  Can it be this simple and still be compliant?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

Hi Tina,

I'm do not think if that approach is compliant with 21 CFR Part 11 as it does not provide a proper trace ability. With the image file, anyone could attach their signature to any copies and claim that it is an official copy of record with signature. It is definitely simple but not compliant.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
------------------------------

Original Message:
Sent: 16-Jun-2019 02:15
From: Tina O'Brien
Subject: Electronic signature vendor for small companies

Very timely topic for me as I'm trying to figure out a way to incorporate a solution for electronic signatures for our paper based QMS that would require little or no validation from a Part 11 perspective.  We're small company and still at least another 1-2 years from electronic QMS, but have people working remotely on a regulatory basis so timely document approval is a total time sucker and ineffecient.

Could we allow staff to scan their wet signature and use that jpeg file to virtually sign QS documents which would then be printed and the paper version filed as the official copy?  Can it be this simple and still be compliant?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

This message was posted by a user wishing to remain anonymous

Hi
Very good discussion.
Following Tina's question and Loganathan's response: if you have a record for the person who is signed on the doc that emphasizes his/her approval for the doc and then you print the signed file- is that OK?
Original Message:
Sent: 17-Jun-2019 01:18
From: Loganathan Kumarasamy, MS RAC
Subject: Electronic signature vendor for small companies

Hi Tina,

I'm do not think if that approach is compliant with 21 CFR Part 11 as it does not provide a proper trace ability. With the image file, anyone could attach their signature to any copies and claim that it is an official copy of record with signature. It is definitely simple but not compliant.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States

Original Message:
Sent: 16-Jun-2019 02:15
From: Tina O'Brien
Subject: Electronic signature vendor for small companies

Very timely topic for me as I'm trying to figure out a way to incorporate a solution for electronic signatures for our paper based QMS that would require little or no validation from a Part 11 perspective.  We're small company and still at least another 1-2 years from electronic QMS, but have people working remotely on a regulatory basis so timely document approval is a total time sucker and ineffecient.

Could we allow staff to scan their wet signature and use that jpeg file to virtually sign QS documents which would then be printed and the paper version filed as the official copy?  Can it be this simple and still be compliant?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

Hi Tina, I think this could be viewed similarly with stamps. There's no traceability to the time/date the signature would be applied. I've used SignIt, Docusign for easy electronic signature. But depending on what your process/product is you may also need to consider record storage and retention. Hope this helps.

------------------------------
Stephanie McArdle
VP Product Management, Life Sciences
Village Of Lakewood IL
United States
------------------------------

Original Message:
Sent: 16-Jun-2019 02:15
From: Tina O'Brien
Subject: Electronic signature vendor for small companies

Very timely topic for me as I'm trying to figure out a way to incorporate a solution for electronic signatures for our paper based QMS that would require little or no validation from a Part 11 perspective.  We're small company and still at least another 1-2 years from electronic QMS, but have people working remotely on a regulatory basis so timely document approval is a total time sucker and ineffecient.

Could we allow staff to scan their wet signature and use that jpeg file to virtually sign QS documents which would then be printed and the paper version filed as the official copy?  Can it be this simple and still be compliant?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

​You can get DocuSign free for the first month and then pay a monthly/annual fee. You can also use the Signature verify feature from Adobe Acrobat DC (not the reader). Either service fulfills the 11 part and all depends on the budget. One caveat, when using the Signature Verified Feature from Adobe, you must be the last signing entity since the document gets locked and thus not able to make any changes. It is a tamper proof feature the FDA truly likes...

------------------------------
[Robert] [Falcone]
[Integris3Biosolutions]
[Bedminster] [NJ]
[US]
------------------------------

Original Message:
Sent: 16-Jun-2019 02:15
From: Tina O'Brien
Subject: Electronic signature vendor for small companies

Very timely topic for me as I'm trying to figure out a way to incorporate a solution for electronic signatures for our paper based QMS that would require little or no validation from a Part 11 perspective.  We're small company and still at least another 1-2 years from electronic QMS, but have people working remotely on a regulatory basis so timely document approval is a total time sucker and ineffecient.

Could we allow staff to scan their wet signature and use that jpeg file to virtually sign QS documents which would then be printed and the paper version filed as the official copy?  Can it be this simple and still be compliant?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

Hello
I use MySignatureBook to manage quality systems and approvals for my clients.  They have done the work to make it 21 CFR 11 compliant.  Every signature has an authentication stamp and full audit trail.  I have procedures that I developed that explain the process around the signature application and the use of Box to store the pdf copies. This setup is particularly useful for small companies with people working remotely. Let me know if I can help set up a similar system for you. 

Tina, I even have a consultant living in New Zealand!

Thank you
Michelle

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------

Original Message------

Hello
I use MySignatureBook to manage quality systems and approvals for my clients.  They have done the work to make it 21 CFR 11 compliant.  Every signature has an authentication stamp and full audit trail.  I have procedures that I developed that explain the process around the signature application and the use of Box to store the pdf copies. This setup is particularly useful for small companies with people working remotely. Let me know if I can help set up a similar system for you. 

Tina, I even have a consultant living in New Zealand!

Thank you
Michelle

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Original Message------

Thanks Michelle – unfortunately, we don't have resources to do the Part 11 work at this time, hence trying to find a hybrid solution that will work with our paper QMS.

 

 

 

Original Message------

Hi Tina

That's the beauty of MySignatureBook.  They did all the work to validate the part 11 work for their tool.  https://www.msbdocs.com/. The signature it applies has a full audit trail and they will even share their validation certificates for you to keep on file. 

Hi, Karen.

Also remember that Part 11 has administrative requirements that are unrelated to the technical implementation (software). We documented Part 11 compliance in a matrix showing how we comply with each requirement. Many of the requirements have an administrative component for compliance. We also documented
"This software module only supports compliance to 21 CFR Part 11 within the context of ...Standard Operating Procedures."

------------------------------
Michael Reents
Bradenton FL
United States
------------------------------

Original Message:
Sent: 11-Jun-2019 13:34
From: Karen Zhou
Subject: Electronic signature vendor for small companies

Hi everyone,

Has anyone had experience with either DocuSign or SignNow for small startup companies of less than 10 people? I hear digital signatures signed with the SignNow app are equivalent to  handwritten signatures (signed with a stylus) rather than electronic signatures. On their website, they say they are part 11 compliant. I would like to get some feedback from those with experience in a startup that has implemented electronic/digital signatures that are part 11 compliant.

Thanks.

------------------------------
Karen Zhou
------------------------------