Hello,
does anyone of you has a productive Totara Learn installation up and running in an FDA compliant environment?
If so - any information (links, use case) would be kind of you.
Thx in advance & best regards
Thomas
Totara Learn Open Discussions
FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Hi Thomas
This document outlines how Totara meets the requirement of FDA CFR part 11 .
We do have a few US government clients who will hopefully give you more details of how they comply using Totara.
Regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Hi Craig,
thank you again for your fast reply and the link you mentioned.
I already have studied that.
For a potential customer i need proof to show, that Totara has the potential to meet his needs.
He already has a FDA compliant environment with a LMS installed but he considers to change it (if the new one could be set up FDA compliant).
Regards
Thomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Hi Thomas
I have asked Daniel our Totara channel manager based in the US to reach out to you as he has worked with organisations using Totara n this environment..
Regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Hi Craig,
thank you for that.
I hope that someone can name a successful implementation.
Regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
hi Thomas
Daniel has contacted the other organisations to see if they are willing to share their story - it's this part that is the difficult bit . Would just the name of an organisation be Ok?
Regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Hi Craig,
if so - only the name would be ok.
Is it ok for you, if we name Totara as reference for this information?
Thank you & regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Hi Craig,
if the opportunity settles some more, the purchase of mentoring services might become conceivable for us.
Regards Thomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Hi Thomas
I have asked Daniel to contact you directly to clarify what information we can provide on this.
An update to this - Daniel is on vacation for a couple of weeks but a couple of others are liaising with the other organisations.
regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
HI Craig,
thank you for your efforts. I am thankful for that.
What i do not understand, is why that is such a secret.
I just need a name and the confirmation that they run Totara in an FDA-compliant environment.
I do not need any how tos or other critical information.
Otherwise we will loose the opportunity to implement Totara at an international working, top technology company.
Regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Thanks Thomas
I am following up with the others to provide some further information on this and hopefully.
I don't think the information is secret but think we still need their consent for this.
Regards
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Dear Craig,
Have you perhaps any more news on this topic? As Thomas is on holiday, I thought I might ask if you have heard anything back from the others.
Any idea would be incredibly helpful to us.
Thanks, Heidi
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
Has anyone new info on that subject?
So there is no productive Totara implementation running in an FDA compliant environment ?
Regards
Thomas