Hello,
I’m working on a project based on automated guided vehicle in a pharmaceutical plant
In order to be sure that all requirements will be notified, I would like to receive some comments
Among other things, audit trail, login/password, alarms and data back up need to be configured in a compliant way (21CFR part 11)
About audit trails, 21 CFR are enough accurate to deploy all requirements
Especially about alarms, what are the necessary requirements?
I’m currently thinking about alarm ID, alarm description, alarm threshold, alarm trigger, alarm set points
Furthermore could you give more informations about specific functions/data/interface requirements?
Thank you so much
Regards
François