G
Guevara
Hello all,
I'm looking for ideas as to how address 21CFR part 11 applicability to a proofreading system (CCD camera reading labels). Main goal is to take proper action so system could be labeled ''21CFR part 11 compliant''.
Process Flow:
1 - master label selected in computer
2 - setup of allowed discrepencies
3 - trial run
4 - on going inspection
5 - if discrepencies detected, flip/flop system pull aside non conforming unit
6 - No link to network, system is not linked to previous or following manufacturing station and end of the shift count dislpayed on screen is validated with physical count of defective units.
Hope this gives a clear picture
I've been going through lot of documentation on the net, but it seems to avoid this specific application.
I'm looking for ideas as to how address 21CFR part 11 applicability to a proofreading system (CCD camera reading labels). Main goal is to take proper action so system could be labeled ''21CFR part 11 compliant''.
Process Flow:
1 - master label selected in computer
2 - setup of allowed discrepencies
3 - trial run
4 - on going inspection
5 - if discrepencies detected, flip/flop system pull aside non conforming unit
6 - No link to network, system is not linked to previous or following manufacturing station and end of the shift count dislpayed on screen is validated with physical count of defective units.
Hope this gives a clear picture
I've been going through lot of documentation on the net, but it seems to avoid this specific application.