Hello! According to GAMP 5 a lot of equipment can be computerized systems. I need some practice advice.
Case 1. For example, we have autoclave, with PLC, users roles, authorised access, we can set up different sterilisation programs, print the latest info about sterilisation etc. Autoclave isn’t connected to PC.
Case 2. We have labeling machine with PLC, touchscreen, user roles, we can set up run-time parameters. There is no logging or printing, Machine isn’t connected to PC.
Case 3. We have usb data logers (temp). Data stored on flash memory. When connected to PC - Software import data from usb logger to PC.
In my view, it is Category 3 by GAMP for all cases. Should we do computer system validation for this cases?
Thanks.