21 cfr part 11 compliance using cloud
Posted: Mon Sep 28, 2015 12:11 pm
by ydna6969
Hi
Anybody using the cloud for data integrity/storage with 21 cfr compliance?
Any thoughts or comments please discuss
Thanks
Re: 21 cfr part 11 compliance using cloud
Posted: Thu Oct 01, 2015 8:00 am
by 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
Re: 21 cfr part 11 compliance using cloud
Posted: Thu Oct 01, 2015 11:51 am
by 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 ?