21 CFR 11 Compliance

[IanSh]

Hi there,

I have a request to make one of my applications 21 CFR 11 Compliant (as part of a wider system). Information regarding this seems quite sparse. I have found the following: Using LabVIEW to Create FDA 21 CFR 11 Compliant Applications and an associated example, both created 2007, and the example uses now out of date functions, though there seem to be some new similar ones.

DSC module appears to have the functionality required still (settings, data, audit trail can go to traces in the citadel DB), but there is little clarity about how to do some parts. For example, I'm even struggling to figure out how our customer would set up user accounts. 

My application currently uses TDMS for both settings and data, and has primitive user management, all of which I'm almost certain would not pass a compliance check. The compliant version would branch off from the main application and be maintained separately in order to be back compatible and cheaper (DSC runtime license...)

Does anyone have experience of making an compliant application? Also happy to hear from any alliance partners etc if you have done this before and are interested in taking on the work. 

Will have to decide whether to go/no go in the next week or two.

Thanks,

[Intaris]

21 CFR part 11 is a time and resource sink.  I come from an analytical science background (pharma) and know this is 1) a big selling point 2) it's a big selling point for a very good reason - it's hard to do and get certified.

If you don't already have experience int his area, my personal advice is to forget it.  Yes, it can be lucrative if you get it actually certified, but for unless you're going to make it a regular feature of your software i.e. this isn't a one-off project, just don't bother.  It opens you up to all kinds of regulatory stuff unless you do an absolute minimal implementation.

[tyk007]

What Intaris said.

I work at a medical device manufacturer and trying to invest in Part 11 has always been a nightmare of opinions, second-hand information and just a general lack of clarity despite the FDA general guidance. But maybe that's just my cynicism.

[T1h0m]

Hello Ian,

Almost 4 years since your question... 

Did something come of this? Were you able to get a 21 CFR compliant software made using DSC?

Regards,

MM.