Off Topic: Electronic Signatures and FDA Part 11 Compliance

[sklett]

Apologies for asking this non-c# question here. I've run out of other
avenues to explore and there are a wealth of bright and experienced
developers active on this group, it is my hope that anyone with experience
with FDA Part 11 or "Electronic Signatures" in general will respond to me.

I have reviewed the various draft and final specification documents and
"Guidance for Industry" released by the FDA, I have also reviewed all other
materials I can find online and I'm still not able to get a clear path
forward for implemented "Electronic Signatures". The specification is very
broad and vague and I'm hoping I can strike up a private thread with someone
that has experience with these topics. I can offer payment if that helps,
although not a lot, I'm a one-man-shop.

Again, apologies for the off-topic, I know it can really bother some people
and I hope you understand.

Have a good weekend,
Steve

 

[clintonG]

I've observed doctors and medicial clinicians doing the MRIs and so on are
using electronic signatures on their paperwork. Developers that write code
for that vertical market is where I would look for peer advice.


<%= Clinton Gallagher
NET csgallagher AT metromilwaukee.com
URL http://clintongallagher.metromilwaukee.com/