21 CFR PART 11 - FDA.COMs Community Forums

Username

Post: 21 CFR PART 11

JohanJ
Member
Posts: 229
JohanJ

Age: 37
Loc: Belgium
Registered on 12-11-07

07-28-08 08:12 PM - Post#4850
In response to IHN1

Dear SDNARE

the qualification of the network has little to do with part 11.
You could say that the network is only a means a servoce to support the activities (applications) you run on it and it is those used applications that need to be part 11.

IVT has sometimes free articles on network qualification. Maybe you can use these articles to understand the difference between network and application qualification.

Regards

Johan Janssens
Mobile: +32 498 68 29 56
e-mail: johan.janssens@qualiphar.com

NOTE: You are viewing an individual Post. View the Entire Topic