Nice explanation Tim Marlow
Yep GAMP 5 is a true nightmare especially when external validation consultants are involved!! :confounded::confounded::tired::rolling:
I remember many projects that never got beyond the URS and Initial Risk assessment stages lol.... Killed dead by estimates for Engineering Controls that made the sirens sound in the Accountants Offices lol.... Started using an intermediate stage with a broad Engineering Design for the FDS and then a broad scope RA and pricing submission to the steering group lol...
Now back to the Hobby Stuff lol....
Yep GAMP 5 is a true nightmare especially when external validation consultants are involved!! :confounded::confounded::tired::rolling:
I remember many projects that never got beyond the URS and Initial Risk assessment stages lol.... Killed dead by estimates for Engineering Controls that made the sirens sound in the Accountants Offices lol.... Started using an intermediate stage with a broad Engineering Design for the FDS and then a broad scope RA and pricing submission to the steering group lol...
Now back to the Hobby Stuff lol....
Comment