21 CFR part 11 validation for SAAS

Question

In a FDA regulated environment applications need to be validated. I've done that tons of times in my career but now I'm facing SAAS. Has anyone out there faced this before? Any FDA related guideline on this scheme?

Besides some black box approach and much support from the provider I see this as hard to do.

Answer 1

I hear ya!

It is impossible...

check out: http://www.vantagesystems.com/Library/Pharmaceutical%20Commerce_Article_%20IMPROVING%20ERP%20IN%20THE%20LIFE%20SCIENCES%20INDUSTRY.pdf

Answer 2

Our platform supports digital signatures that are 21 CFR Part II compliant. We actually have a video of it here: http://www.longjumpblog.com/blog/2010/05/25/delving-deep-into-digital-signatures/