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System Validation according FDA 21 CFR part 11

 
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System Validation according FDA 21 CFR part 11
?? 发表于 2020年09月3日 Thursday 09:11
 

Dear Community,

we are close to install the Totara platform for our organization. We are dealing in the Healthcare sector and therefore need to validate the whole tool according FDA 21 CFR part 11.

Does anyone has experience with it? Does Totara provide any documentation?

Any support/feedback is highly appreciated.

Kindest

Manfred

Craig Eves
Re: System Validation according FDA 21 CFR part 11
Eves (Totara Support)Craig 发表于 2020年09月3日 Thursday 15:57
 

Hi Manfred

There is some documentation on Totara compliance to FDA 21 CFR Part 11 here  plus links to other compliance standards.

Please contact us if you have any questions on this.

Regards





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Re: System Validation according FDA 21 CFR part 11
?? 发表于 2020年09月4日 Friday 04:02
 

Brilliant. Thanks Craig for the speedy response. Very useful information.

Kind Regards

Manfred