We work in an ISO 7 cleanroom environment. Our QC lab does testing and then needs to report those results to the cleanroom. It takes roughly 30 minutes for staff to clean materials, gown and pass the results into the room. We were thinking of implementing computer tablets in the cleanrooms so our QC techs can just scan the results into the room and save considerable amounts of time.
We are hung up on the whole electronic record part 11 scenario. Half of our group thinks the scanned file is an electronic record subject to part 11, and half think its just like a copy.