Hi Stanley and Gassert,
I found way to your post when I was searching information about Moodle and compliance to FDA's CFR 21 Part 11.
I have a requirement where I need to tell FDA regulated Pharma company (who is planning to use Moodle as their LMS) whether Moodle conforms to CFR 21 Part 11 guidelines or not.
I believe it does conform to standards considering user name and password combination as means to allow access to system which is synonymous to electronic signature. Also when it comes audit trail, Moodle does maintain audit of system users, their Sign in, Sign out time, roles, permissions, who launched the course, who deleted it, who scored how much and on which course etc. I believe this is what is called Audit Trail if I am not wrong.
Also, see below how SyberWorks LMS claims it is FDA compliant and in similar lines Moodle also does support all those features.
In that sense is it safe to consider Moodle also compliant with CFR 21 Part 11 guidelines?
http://www.syberworks.com/21CFRPart11-learning-management-systems.htm
Thanks,
Narayan