Wearables 21 CFR Part 11 compliance

#1
Hi,

I want to use my medical - grade wearables to help sponsors capture data in a clinical trial, which will then be transmitted to the cloud for storage and retrieval.

Do I need to ensure that the whole system is 21 CFR Part 11 compliant? In other words, does part 11 applies when the data is stored temporarily in the device for 2-3 days?

Thank you!
 
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yodon

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#2
Putting the regulation aside for just a moment, how do you know your data (stored) is accurate, correct, complete, unaltered, ...? How about when transmitted to the cloud? Is it the same (accurate, complete, correct, unaltered,...)?

Given what you describe, I wouldn't think anyone would take any enforcement action around Part 11 (not a guarantee, though). You're several layers away of any records that are required under predicate rule. Make sure all those other aspects are addressed and you should be fine.
 
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