Totara Learn Open Discussions

FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?

Welcome to this forum!

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

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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

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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

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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

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Hi Craig,

thank you for that.

I hope that someone can name a successful implementation.

Regards

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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

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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

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Hi Craig,

if the opportunity settles some more, the purchase of mentoring services might become conceivable for us.

Regards Thomas

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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

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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

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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

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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

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Has anyone new info on that subject?

So there is no productive Totara implementation running in an FDA compliant environment ?

Regards

Thomas

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