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Helper I
Helper I

GXP Powerapp - FDA compliance

Long shot here, but I'm curious if anyone working in a FDA-regulated GxP environment is making/using PowerApps.

 

Seems like it would be difficult or impossible to implement the controls required by 21CFR11 etc. regarding electronic signatures, audit trails, control of the records/files, and control of the application as a whole. Has anyone had success? Has anyone VALIDATED a PowerApp?

 

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Helper II
Helper II

Re: GXP Powerapp - FDA compliance

I've developed 21 CFR Part 11 systems for clinical trials (EDC, eSource). I would expect that the compliance would come down to what's supporting the data, i.e., SQL, CRM, Sharepoint, etc. So long as the database provides the auditing required and you're able to force logouts for security checks, I'm sure you could make an argument that the environment is compliant. I wouldn't want to sit in the audit room when trying to make the argument, but I could see a pathway.

 

Depending on what you're trying to build, I would probably recommend working with a vendor that provides Part 11 compliance and validation documentation instead of going out on your own.

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Helper I
Helper I

Re: GXP Powerapp - FDA compliance

@eauerbachThe challenge (or opportunity) is using PowerApps where the scale, budget, and criticality does not justify a third party or bespoke software solution. However not sure how to overcome many of the obstacles on front-end, such as applying 21CFR11 electronic signatures. Maybe I'm asking for too much here but just curious if anyone has been able to do it.

 

For example, would be a ton of value in submitting/approving a form electronically vs on paper. Can build an app to do that in 5 minutes but getting it compliant is an entire other question.

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