I’ve been involved in design and validation of lab/production equipment for several years, and it has recently fallen on me to validate a GE AKTA purifier (FPLC, running Unicorn Software). The question is, we are still in late product development and our business uses a paper based lab book and batch record system. Therefore, as no electronic data is being used or stored for submissions/traceability etc etc does this negate the need for ‘Part 11 validation’?
Secondly: Currently the system is being used for antibody purification, which can relatively easily be ‘100% inspected’ for quality; point being that if you can 100% inspect, the need for validaton is minimal?
Steve
I don’t understand your problem.
If you are not using electronic means to store your predicate data then part 11 does not apply. Just print out your data and make sure it is signed off, approved and dated; then store as hard copy.
Even if the output is 100% inspectable you are required to validate the process. It is unfortunate that certain regulators use this wording in 483 citation;
Failing to validate a process when the outcome is not inspectable.
It gives you the impression that - if you can inspect - then you do not have to validate.
This is quite erroneous, as the majority of processes in a pharmaceutical plant are inspectable and have to be validated.
It really just means when you cannot inspect; then the validation must be much more rigorous.