Digital Signature Solutions acceptable to use in an FDA Medical Device Environment

B

Bunny

#1
Can anyone recommend a Digital Signature Solution package that would be acceptable to use in a FDA medical device environment? I am looking for a better way to capture my colleagues approvals. Right now we have to scan pdf documents between offices to obtain signature approvals. It is an administrative headache.
 
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M

maaquilino

#2
Re: Digital Signature Solutions

If you Google - Digital Signature Solution regulated environment - a list of companies comes up. The only one I've had recent experience with is Documentum, which was so highly customized for the company using it that it was ridiculous, and was a pain to validate, especially when updates were made to the core Documentum software. In this company, many projects spanned several facilities across several countries and/or states, so there were numerous signatories, and they were faxed/emailed to the main project site.

The biggest issue with any software used for documents in a regulated environment is that you have to ensure it meets the regulations for document control and you have to validate it. That can sometimes be more of a headache than scanning pdfs for signatures. Lots of companies don't have the time, budget or people to put together a project team and do all the documents and work required for a validation, or they don't see the need to do it, yet the FDA states:
"Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR ?820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system."

http://www.fda.gov/medicaldevices/d...guidancedocuments/ucm085281.htm#_Toc517237933
 

Mark Meer

Trusted Information Resource
#3
Re: Digital Signature Solutions

...and was a pain to validate, especially when updates were made to the core ... software.
Surely there is an expedited way to validate OTS digital signature software.

For example, Adobe Acrobat, which is now incorporating e-signatures specifically for this purpose of having to do away with repeated signings and scannings.

If onerous validation is required everytime Adobe releases an update patch, it would be tantamount to the FDA actively stifling the transition to digital signatures (which are, IMHO, actually more reliable in terms of document authentication than traditional signatures and scanned documents...).
 
M

maaquilino

#4
Re: Digital Signature Solutions

Surely there is an expedited way to validate OTS digital signature software.

For example, Adobe Acrobat, which is now incorporating e-signatures specifically for this purpose of having to do away with repeated signings and scannings.

If onerous validation is required everytime Adobe releases an update patch, it would be tantamount to the FDA actively stifling the transition to digital signatures (which are, IMHO, actually more reliable in terms of document authentication than traditional signatures and scanned documents...).
Sure there is...but there isn't when the company using the OTS customizes it heavily. This company took the core Documentum software and customized about 70+% of it...which meant that validating it wasn't as simple as validating OTS for its' intended use. And once it was validated and 2 years later Documentum made numerous changes to their software, in order to update the company's heavily customized version of it, numerous changes had to be made to their version so it would be compatible with the new version of Documentum, and that all had to be validated again. It was a mess and as far as I know, it still is.

IMO, the main problems were 1) too heavily customizing OTS software in the first place (they did some of it because at that time Documentum didn't meet all the regulatory needs we had to meet) and 2) some people in the company weren't willing to change processes they had done the same way forever in order to meet what the software could do; if I never hear 'but we've always done it this way again' it won't be too soon. If they would have changed their processes the software wouldn't have needed so much customization, and would have been easily updated and re-validated after updates.
 

mihzago

Trusted Information Resource
#5
Re: Digital Signature Solutions acceptable to use in an FDA Medical Device Environmen

There are several tools on the market.
If you're looking for a SaaS solution then DocuSign may be a good tool, which I've been using for almost a year now. Easy to set-up and fairly inexpensive.

I was also using Arx CoSign, but that seemed to be a better solution for on premises installation. Great integration with SharePoint, but poor Mac support. They have a Web App, but back then it wasn't compliant with Part 11.
 
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