Re: Auditing Returned Goods Tracking System - Tracking returned Class 1 Medical Devic
One aspect of this project will, I think, be doing some assessment around 21 CFR Part 11, Electronic Signatures — Scope and Application.
I have the August, 2003 "Guidance for Industry" document. I think this is the latest available information on this Part of the CFR.
I'd be grateful for any assessment advice anyone might have on this set of regulations. In the interim, I'm going to be scouting around for an existing checklist, before developing my own.