Is this training records signature app FDA compliant?

H

hlg1102

#1
I currently oversee training records for a small medical device company. Our field sales personnel are intending to use a cell phone app. known as SignNow to sign training forms which are then faxed or scanned back to me. It allows the trainee to sign on the phone screen displaying the training document.

I find this practice risky from an FDA compliance standpoint. Does it meet 21 CFR part 11? If not, can it be made compliant? I suspect there would be a validation requirement to use such software. :evidence:
 
Elsmar Forum Sponsor
#2
Is this signature app FDA compliant ?

I currently oversee training records for a small medical device company. Our field sales personnel are intending to use a cell phone app. known as SignNow to sign training forms which are then faxed or scanned back to me. It allows the trainee to sign on the phone screen displaying the training document.

I find this practice risky from an FDA compliance standpoint. Does it meet 21 CFR part 11? If not, can it be made compliant? I suspect there would be a validation requirement to use such software. :evidence:
They claim to be legally secured, have bank security etc but you can check with them if they are compliant to FDA requirements.
 

v9991

Trusted Information Resource
#3
Re: Is this signature app FDA compliant ?

short ans is ...haven't worked with that specific tool/scope
BUT your question does not end with status/capability of tool to be compliant with FDA...

here's quick thoughts on what to look for...(with certain assumptions about the system...that existing system is compliance and you intend to replace the existing e-signature with this new tool...existing sytem runs on validated internal environment (VPN - intranet etc.)))...

FDA requirements on subject matter are a combination of e-records and e-signatures. further, it also talks about combination of methods through which e-signature requirements can be met...

now, in this case,
a) how effectively(design controls ) the tools integrates with e-records and associated requirements of audit trail....and
b) also how effectively (system/procedural controls) on the
b.1) first,how the mobile application actually identifies the respective individual/personnel...
b.2) second, associated extended scope of validation of application over the internet. (which i believe is little different from that normal VPN which is more of controlled environment!!!)
etc.,

here's the reference for b.2) ....ref. sec 6.1.2 and 6.2
http ://www. fda. gov/downloads/regulatoryinformation/guidances/ucm124946.pdf - DEAD 404 LINK UNLINKED

detailed expectations on the b.1 at
http ://www .gpo. gov /fdsys/pkg/FR-1997-03-20/pdf/97-6833.pdf - DEAD 404 LINK UNLINKED

hope this helps...
 
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sagai

Quite Involved in Discussions
#4
I would have two dumb questions. :eek:

What makes you think that the training record is mandated by the CFR to be signed by the trainee ?

And why do you think that the training of the field sales people are subject to the cGMP?

Many thanks, Cheers!
 
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L

Lucasmf

#5
If the app has the sign with their handwritten signature then it is technically not an electronic signature subject to Part 11. What would be the difference to them signing the paper document and faxing you a copy? If the fax copy you retain is your original record it sounds like this app just saves you the trouble of printing out the document versus old fashioned paper and scan.
 

v9991

Trusted Information Resource
#6
What makes you think that the training record is mandated by the CFR to be signed by the trainee ?
here's one example where the sign in is demonstrated as an
http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM092140.pdf

And why do you think that the training of the field sales people are subject to the cGMP?
especially the sales training materials are an extension of "approved label claims and indications" ... the medium used to promote the product with the doctors / pharmacies. Hence it would be if not directly-relevant but an extension to part/purview of the regulations (if not cGMPs but other requirements!!!)
here's few ref...
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf
 

sagai

Quite Involved in Discussions
#7
I like the example you have for the Training Procedure, however the CFR does not say, that the trainee shall sign off the training record itself.
It is saying, Training shall be documented, and as such it is up to you how you demonstrate your compliance with it. May be the trainees are signing of the attendees sheet, may be the trainer signing off the training sheet for all of them, may be there is a test at the end and the test is the demonstration that the training was carried out, etc.
Multiple ways are exist, we should avoid canned thinking.

The second link you provided was a draft guidance, well, it is really worthwhile to know what are the planned non binding recommendation of FDA, but it is not really mandated, and to be honest with you, I do not found any clause in the CFR as regard to sales because of a very simple reason, the CFR is regulatory focus, if you look and search it does not even have the word, "Customer".
It really up to the real activities carried out by the sales people, but in general, their activities are not really subject to the cGMP, but I am happy to learn otherwise.

Sum it up, this situation smells there is a rigmarole is going on ... but it is my wee, own impression.

Many thanks, Cheers
 
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v9991

Trusted Information Resource
#8
... however the CFR does not say, that the trainee shall sign off the training record itself. It is saying, Training shall be documented, and as such it is up to you how you demonstrate your compliance with it. May be the trainees are signing of the attendees sheet, may be the trainer signing off the training sheet for all of them, may be there is a test at the end and the test is the demonstration that the training was carried out, etc.
Multiple ways are exist, we should avoid canned thinking.
True, this aspect '...of multiple ways exist...'is not disputed at all...
Purpose of providing the reference above is as solely for reference!!!...

now consider a probable scenario, where sales personnel are remotely attending the training sessions (could be webinar, online class rooms etc.,); what would you suggest as an procedure to capture training attendance? anyways,

...
Multiple ways are exist, we should avoid canned thinking.
True indeed ...that each organization has almost unique scenario and respective levels of maturity...
its upto various factors ...which actually determines the level of scrutiny/documentation which is established to demonstrate the compliance...


The second link you provided was a draft guidance, well, it is really worthwhile to know what are the planned non binding recommendation of FDA, but it is not really mandated, and to be honest with you, I do not found any clause in the CFR as regard to sales because of a very simple reason, the CFR is regulatory focus, if you look and search it does not even have the word, "Customer".
It really up to the real activities carried out by the sales people, but in general, their activities are not really subject to the cGMP, but I am happy to learn otherwise.
in my earlier post, its only meant to provide reference for need of promotional materials to be in line(traceability) with the approved label claims and indications. ( not exactly to establish the traceability to CFRs.) surely, expert could provide more light on this area about organizations liability/responsibility thorugh life cycle of product..

Sum it up, this situation smells there is a rigmarole is going on ... but it is rarely my own impression.
not too sure about this part...however, since OPs post was specifically targetted towards the part-11 compliance of a specific signature-tool...my first post was with focus on that subject; (also note the i am assuming certain other things about state of compliance and adequacy/appropriateness of systems etc + i did add that i didnt work in that sales-domain as well!!! )
 

sagai

Quite Involved in Discussions
#9
I am happy to reach the point where we instead of working out a point solution we take a holistic view of the problem first.
That was all about. :bigwave:

NB: My personal opinion, I do not think in general the sales people's trainings in are subject to CFR. How we document it? ... it is up to us, but it is not up to compliance question that opens the rat-hole of the part11.
 

v9991

Trusted Information Resource
#10
...got little more curious did some search for some references...and here's few references regarding the link between promotional (sales) training materials and label claim/ indications...
slide 7,9,...
http :// www. hoganlovells. com/files/Event/21cb34f5-0d30-47cd-950f-58999c1c927d/Presentation/EventAttachment/91d52da1-6695-4668-a3e3-38b5f94d88a7/Webinar Off-Label Promotion for Devices032609.pdf - LONG OUTDATED BROKEN LINK UNLINKED
ref. slide 36... http :// www .huronconsultinggroup .com/library/The New Era of Off-Label Marketing Enforcement.pdf - BROKEN LINK UNLINKED

pg 34 & 35

http://www.justice.gov/opa/documents/gsk/plea-ex-d.pdf
 
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