File Management system in Cloud for Medical Mobile Apps

[QAengineer13]

I need some guidance for managing mobile medical apps, system config files in cloud, is there any guidance documents for managing DMR (i.e Master media set- Containing System Config file) in cloud for mobile app.

Any input/suggestion will be greatly appreciated.

 

[yodon]

My immediate thought is to suggest you first ensure that your app needs to be managed as a medical device. Have you reviewed: (broken link removed)

If it is a medical device and a DMR is required, then the regulation (21 CFR 820.181) defines what's expected: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.181

And if it's an electronic record and/or electronically signed, then Part 11 compliance would be expected: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

Note that a system config file would be considered a design output / part of the system that would need to be managed. You'd need to demonstrate that maintaining it in the cloud is secure and controlled.

 

[QAengineer13]

Hi Yodon,

Thank you for your suggestion and guidance.

I have reviewed the Medical apps, and this product is an inventory dashboard so its not direct medical device application , its a management tool for supplies.

I strongly feel it should be Part 11 complaint and the design o/p requirements.

Thank you!