Hi all, I’d just like to get some views on this:
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?
I’d very much appreciate your views.