Different companies put that documentation in different files. In some companies, that information
is in the development report; in some, it’s in the validation protocol; and in some, it’s in
engineering source documents. We did not try to reference specifically which document would
identify, what was critical. It was the EWG ‘s opinion that the validation protocol was too late for
defining what would be critical. By that point, the development reports should have already
identified from R&D and from engineering what they pre-define as critical areas of concern.
