GXP Powerapp - FDA compliance

[Anonymous]

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?

[eauerbach]

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.

[Anonymous]

@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.

[muralidharan]

Hi @Anonymous ,

Did you sorted out this for CFR Part 11 compliance for the PowerApps ?

Thanks,

Murali.

[rbalani]

Best bet --use Sharepoint as data source with any Powerapps app developed.

Sharepoint has full ALCOA FDA regulations support out of the box, e.g. full document versions control, app files, etc 

Additionally-Microsoft has publisheda a 3rd party audit to this effect.
Let me know if this helps and you need more information-see our estarhelper.com (eSTARhelper in MS Teams - fully described how )

Ram Balani

CEO

eSTARHelper.com (eSTARHelper LLC/ FDAsmart Inc.

[cv1617]

Hello! I am interested to find out if you have any updates. Were you able to figure this out? 

[Anonymous]

Currently developing/validating several Powerapps, some of which have functions that impact GxP decisions in pharma realm therefore validation is applicable.  Using Sql db for all.  None of them apply e-sig to records as any records output from the apps that require approval are being routed for approval and stored in Veeva. There are some connector that could be used for e-signature but we have decided to keep all our deliverable type documents and  approvals thereof in our central document management system.

See no issues with using Powerapps for simple GxP uses.  Biggest challenge is right sizing validation when dealing with a validation life cycle process that is geared toward the traditionally more complex IT systems.

[Anonymous_Hippo]

I am curious to know if anyone utilizes VEEVA and PowerApps to map processes that do not reside in VEEVA. How hard or easier has the data pull from VEEVA to SQL vs VEEVA to Dataverse been ?