CFR 21 Part 11 Compliance

CFR 21 Part 11 Compliance

de Harvy Stanley -
Número de respuestas: 5

Does anyone happen to know if Moodle is CFR 21 Part 11 compliant?  It is a pharma / healthcare FDA regulation.  I am running moodle for a pharma company now for some of its training needs.  In order to use it for training on their "validated" systems though Moodle would have to be CFR21 Part 11.  Just curious if anyone else had encountered this before.

Thanks!

Harvy

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En respuesta a Harvy Stanley

Re: CFR 21 Part 11 Compliance

de Hannes Gassert -
CFR 21 Part 11 (interesting document btw) is about "Electronic Records; Electronic Signatures; Maintenance of Electronic Records", so I don't think it even applies in the case when your dealing with e-learning, not with actual medical records.
If it would apply, Moodle would not comply - no audit trail for content, no electronic signatures.

HTH,
H.
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En respuesta a Hannes Gassert

Re: CFR 21 Part 11 Compliance

de Harvy Stanley -
Thanks for the input.  Unfortunately, in a pharma company it does apply to trainining if the training is GMP related.  (FDA is a stickler for detail).
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En respuesta a Harvy Stanley

Re: CFR 21 Part 11 Compliance

de Narayan Gopal -

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

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En respuesta a Narayan Gopal

Re: CFR 21 Part 11 Compliance

de Richard Oelmann -
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I'm not familiar with CFR itself, but in terms of what you describe, Moodle has a robust authentication system which full identifies and logs user sign in and out - assuming the courses concerned have not been left as 'open' access that does not require any log in. It also has full and comprehensive log records of all actions.

This is probably a good example of whre it would be beneficial to start a new discussion thread and not open up a discussion from over 10 years ago. Moodle has changed and moved on a lot in that time!

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