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System Validation according FDA 21 CFR part 11

 
Manfred Lirsch
System Validation according FDA 21 CFR part 11
by Manfred Lirsch - Thursday, 3 September 2020, 9:11 AM
 

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

 
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Craig Eves
Re: System Validation according FDA 21 CFR part 11
by Craig Eves (Totara Support) - Thursday, 3 September 2020, 3:57 PM
Group Totara

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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Manfred Lirsch
Re: System Validation according FDA 21 CFR part 11
by Manfred Lirsch - Friday, 4 September 2020, 4:02 AM
 

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

Kind Regards

Manfred

 
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