Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am working in Europe with a European medical device start up that intends its devices to be marketed in the US in 2 or 3 years time. The company is intending to introduce electronic? digital? signatures to most of their internal documents.
I am aware of 21 CFR Part 11 but not particularly knowledgeable regarding IT.
It would be great if I could get guidance or pointed to guidance regarding the following:

1. Does anyone use sharepoint "Collect signatures" for electronic signatures and deem it suitable for Part 11?
2. Does anyone know of a good value and compliant electronic / digital signature solution for a small pre-revenue organisation?
3. Does anyone know whether using a tablet/stylus type system rather than a wet signature is compliant?

Thank you

I haven't use Sharepoint for a long time, so I cannot answer that question. We use Adobe Acrobat DC for our electronic signatures, but you must make sure that it is set up with certificate-based signatures that require the signer to re-enter their password and designate a reason for signing. There is other software, but since we already use Adobe it was a cost-effective solution. It is possible to sign on a device.

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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 23-Jan-2019 08:57
From: Anonymous Member
Subject: Electronic signatures Part 11

This message was posted by a user wishing to remain anonymous

I am working in Europe with a European medical device start up that intends its devices to be marketed in the US in 2 or 3 years time. The company is intending to introduce electronic? digital? signatures to most of their internal documents.
I am aware of 21 CFR Part 11 but not particularly knowledgeable regarding IT.
It would be great if I could get guidance or pointed to guidance regarding the following:

1. Does anyone use sharepoint "Collect signatures" for electronic signatures and deem it suitable for Part 11?
2. Does anyone know of a good value and compliant electronic / digital signature solution for a small pre-revenue organisation?
3. Does anyone know whether using a tablet/stylus type system rather than a wet signature is compliant?

Thank you

As long as the software system is qualified.  I don't see using any software or system.  We have in-house software system for our warehouse, and FDA nor any regulatory bodies is asking for qualification documents. CFR Part 11 is all about restricted and secure access in my opinion.

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Eugene Lee
60026 IL
United States
------------------------------

Original Message:
Sent: 23-Jan-2019 08:57
From: Anonymous Member
Subject: Electronic signatures Part 11

This message was posted by a user wishing to remain anonymous

I am working in Europe with a European medical device start up that intends its devices to be marketed in the US in 2 or 3 years time. The company is intending to introduce electronic? digital? signatures to most of their internal documents.
I am aware of 21 CFR Part 11 but not particularly knowledgeable regarding IT.
It would be great if I could get guidance or pointed to guidance regarding the following:

1. Does anyone use sharepoint "Collect signatures" for electronic signatures and deem it suitable for Part 11?
2. Does anyone know of a good value and compliant electronic / digital signature solution for a small pre-revenue organisation?
3. Does anyone know whether using a tablet/stylus type system rather than a wet signature is compliant?

Thank you

I think it may not be that simple:  https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf

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Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 23-Jan-2019 13:24
From: Eugene Lee
Subject: Electronic signatures Part 11

As long as the software system is qualified.  I don't see using any software or system.  We have in-house software system for our warehouse, and FDA nor any regulatory bodies is asking for qualification documents. CFR Part 11 is all about restricted and secure access in my opinion.

------------------------------
Eugene Lee
60026 IL
United States

Original Message:
Sent: 23-Jan-2019 08:57
From: Anonymous Member
Subject: Electronic signatures Part 11

This message was posted by a user wishing to remain anonymous

I am working in Europe with a European medical device start up that intends its devices to be marketed in the US in 2 or 3 years time. The company is intending to introduce electronic? digital? signatures to most of their internal documents.
I am aware of 21 CFR Part 11 but not particularly knowledgeable regarding IT.
It would be great if I could get guidance or pointed to guidance regarding the following:

1. Does anyone use sharepoint "Collect signatures" for electronic signatures and deem it suitable for Part 11?
2. Does anyone know of a good value and compliant electronic / digital signature solution for a small pre-revenue organisation?
3. Does anyone know whether using a tablet/stylus type system rather than a wet signature is compliant?

Thank you

Hello Anonymous,

ISOXpress has a functional eDMS (IMSXpress) at a very reasonable price, Part 11 compliant and relatively easy to use, but they will.still want to have a document administration role.  About 5-10K for 10 users a year.  They may grow out of it but this one is a good start for very small pre-revenue companies. It does have some integrated post-market modules, like complaints, CAPA, Non-comformities.  Take a demo and see what you think. They also sell an inexpensive starter pack of procedures you can customize.

Also, I was introduced to Matrix, a new system that can be had for under 10k. But it does not include any post-market features at that price, or didn't when I looked in Sept/October.

The other biggies are pretty expensive , starting at maybe 25k (Greenlight Guru, Trackwise, Veeva, Etc), but some offer free webinars and training (Greenlight).  

I started my first client with IMSXpress, as that was what they could practically afford. And it got them off Google Docs! Maybe they will migrate to.a larger system.in the future, but TUV SUD liked it when they audited them ( and successfully passed) to ISO 13485:2016 last year.






​

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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 23-Jan-2019 08:57
From: Anonymous Member
Subject: Electronic signatures Part 11

This message was posted by a user wishing to remain anonymous

I am working in Europe with a European medical device start up that intends its devices to be marketed in the US in 2 or 3 years time. The company is intending to introduce electronic? digital? signatures to most of their internal documents.
I am aware of 21 CFR Part 11 but not particularly knowledgeable regarding IT.
It would be great if I could get guidance or pointed to guidance regarding the following:

1. Does anyone use sharepoint "Collect signatures" for electronic signatures and deem it suitable for Part 11?
2. Does anyone know of a good value and compliant electronic / digital signature solution for a small pre-revenue organisation?
3. Does anyone know whether using a tablet/stylus type system rather than a wet signature is compliant?

Thank you

Hi Anon.

I see a lot of people offering opinions on your questions 1 and 2 but so far no one has seemingly taken a shot at 3.  So....let me tackle that one.

My opinion is that tablet/stylus is essentially the equivalent to pen and paper signature.  As such there should not be any difference between using a pen and paper or the stylus.  Think about it - courts have enforced tablet stylus signatures for things like contract signings as well as signing for your purchase at a retailer.  I can't see any true difference between the level of assurance the company would need to prove in those situations as opposed to what the FDA would need to prove in court.  Let's face it...the reason for the signature is essentially to prove the process was completed satisfactorily or in some cases to complete some other form of investigation.  That said, the difference between a "wet signature" and a stylus signature is really no difference.  But I will advise that you should be very careful about tablet-stylus signatures to ensure that there is no way to "over-write" or "over-ride" those signatures once the document is signed and completed.  Otherwise you will have lots of other traceability problems.​

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Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 23-Jan-2019 08:57
From: Anonymous Member
Subject: Electronic signatures Part 11

This message was posted by a user wishing to remain anonymous

I am working in Europe with a European medical device start up that intends its devices to be marketed in the US in 2 or 3 years time. The company is intending to introduce electronic? digital? signatures to most of their internal documents.
I am aware of 21 CFR Part 11 but not particularly knowledgeable regarding IT.
It would be great if I could get guidance or pointed to guidance regarding the following:

1. Does anyone use sharepoint "Collect signatures" for electronic signatures and deem it suitable for Part 11?
2. Does anyone know of a good value and compliant electronic / digital signature solution for a small pre-revenue organisation?
3. Does anyone know whether using a tablet/stylus type system rather than a wet signature is compliant?

Thank you

I recommend that Part 11 be read by all here, in particular Subpart C, Electronic Signatures (11.100 to 11.300). This Subpart describes two options for electronic signatures - biometrics or unique ID and password. Since it is more difficult to establish biometric systems, I will just cite the ID and password approach with my added emphasis:  "Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity."  Part 11 compliant electronic signatures, in my understanding, are not valid if each time you sign you enter your password or some other method that ensures that some other individual cannot apply your signature.

I think that all would agree that if someone forged your "wet signature" you could try to deny it was your signature by handwriting analysis, because successful forgery is a very difficult art.  The problem with any electronic signature is that you may not be able to prove that someone didn't copy and paste your actual signature onto the document. For that reason, FDA has rules for electronic signatures related to predicate documents. If you or your company intends to submit predicate documents with electronic signatures, you are required to sign and submit a non-repudiation statement (with a wet signature), saying that you cannot ever deny that it was your signature.  Therefore, you have to have a system that maintains security AND integrity of your electronic signature.

I don't know whether FDA  is still using enforcement discretion on this point, but I think it is very risky not to implement a proper electronic signature system for a company's own risk management.

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Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 24-Jan-2019 16:36
From: Victor Mencarelli
Subject: Electronic signatures Part 11

Hi Anon.

I see a lot of people offering opinions on your questions 1 and 2 but so far no one has seemingly taken a shot at 3.  So....let me tackle that one.

My opinion is that tablet/stylus is essentially the equivalent to pen and paper signature.  As such there should not be any difference between using a pen and paper or the stylus.  Think about it - courts have enforced tablet stylus signatures for things like contract signings as well as signing for your purchase at a retailer.  I can't see any true difference between the level of assurance the company would need to prove in those situations as opposed to what the FDA would need to prove in court.  Let's face it...the reason for the signature is essentially to prove the process was completed satisfactorily or in some cases to complete some other form of investigation.  That said, the difference between a "wet signature" and a stylus signature is really no difference.  But I will advise that you should be very careful about tablet-stylus signatures to ensure that there is no way to "over-write" or "over-ride" those signatures once the document is signed and completed.  Otherwise you will have lots of other traceability problems.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 23-Jan-2019 08:57
From: Anonymous Member
Subject: Electronic signatures Part 11

This message was posted by a user wishing to remain anonymous

I am working in Europe with a European medical device start up that intends its devices to be marketed in the US in 2 or 3 years time. The company is intending to introduce electronic? digital? signatures to most of their internal documents.
I am aware of 21 CFR Part 11 but not particularly knowledgeable regarding IT.
It would be great if I could get guidance or pointed to guidance regarding the following:

1. Does anyone use sharepoint "Collect signatures" for electronic signatures and deem it suitable for Part 11?
2. Does anyone know of a good value and compliant electronic / digital signature solution for a small pre-revenue organisation?
3. Does anyone know whether using a tablet/stylus type system rather than a wet signature is compliant?

Thank you