Validation of Applications in a Cloud, CFR 21 part 11 (Environmental Monitoring)

C

clupin

#1
Does anyone have experience validating a cloud service for compliance with CFR 21 part 11? We are interested in subscribing to a environmental monitoring service that claims to be part 11 complaint and are looking for guidance on validating in this realm.

tia
 
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yodon

Staff member
Super Moderator
#3
Is the service provider willing to share the validation results demonstrating Part 11 compliance? If not, you may be at risk to substantiate claims of compliance.

I expect you'll still have to demonstrate that you'll be using int in a manner that's compliant with Part 11. In some cases, the software allows you to do things that aren't compliant and so you have to wrap some procedure around it to ensure you're using it properly.
 
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