Totara Learn Open Discussions

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

 
HummelsbergerThomas
FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 HummelsbergerThomas 发表于 2019年08月8日 Thursday 07:27
小组 Partners

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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Craig Eves
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 Eves (Totara Support)Craig 发表于 2019年08月8日 Thursday 17:20
小组 Totara

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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HummelsbergerThomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 HummelsbergerThomas 发表于 2019年08月8日 Thursday 23:29
小组 Partners

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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Craig Eves
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 Eves (Totara Support)Craig 发表于 2019年08月11日 Sunday 13:59
小组 Totara

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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HummelsbergerThomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 HummelsbergerThomas 发表于 2019年08月13日 Tuesday 01:09
小组 Partners
Hi Craig,


thank you for that.

I hope that someone can name a successful implementation.


Regards

 
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Craig Eves
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 Eves (Totara Support)Craig 发表于 2019年08月13日 Tuesday 16:17
小组 Totara

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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HummelsbergerThomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 HummelsbergerThomas 发表于 2019年08月13日 Tuesday 23:28
小组 Partners

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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HummelsbergerThomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 HummelsbergerThomas 发表于 2019年08月13日 Tuesday 23:34
小组 Partners

Hi Craig,

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

Regards Thomas

 
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Craig Eves
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 Eves (Totara Support)Craig 发表于 2019年08月15日 Thursday 14:33
小组 Totara

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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HummelsbergerThomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 HummelsbergerThomas 发表于 2019年08月19日 Monday 01:31
小组 Partners
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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Craig Eves
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 Eves (Totara Support)Craig 发表于 2019年08月19日 Monday 17:10
小组 Totara

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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RiesebieterHeidi
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 RiesebieterHeidi 发表于 2019年08月29日 Thursday 01:06
 

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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HummelsbergerThomas
Re: FDA compliancy with Totara Learn (FDA 21CFR Part 11) ?
由 HummelsbergerThomas 发表于 2019年10月8日 Tuesday 06:30
小组 Partners

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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