21 cfr part 11 compliance using cloud

[ydna6969]

Hi

Anybody using the cloud for data integrity/storage with 21 cfr compliance?

Any thoughts or comments please discuss

Thanks

[Csaba]

Well, as I see it; validation is about control: Why who did what when (IOQ, PQ) and remain in a controlled state fullfilling the URS with an appropiate design (DQ). With a cloud solution, the cloud provider will change what ever they want when ever whithout even inform you in advance, and not caring about your URS and workflows. So as I see it, a cloud solution can NEVER be a controlled system (stay validated). End of story. /Csaba

[ydna6969]

thanks for reply ..

I am not convinced ,,the orange book /annex 11 does discuss this setup is possible with compliance :

For example :


http://www.validatedcloud.com/

any thoughts ?