the scenario is that, above reports are compiled into summary reports (Inhouse purpose), and excepts of which are part of FDA submission.
Yes, raw data & analytical reports - final documentation submitted to FDA are already part-11 compliant.
is part 11 applicable to report compilations of (R&D)development data?
counter :- since compilations are ih requirement; and raw data and final document is controlled(part-11); compilations need not be subjected to part-11 requirements.
our argument :- as the summary document is basis for submission documentation; this would be under purview of electronic documentation; and further it would have to meet requirements of hybrid system.
Yes, raw data & analytical reports - final documentation submitted to FDA are already part-11 compliant.
is part 11 applicable to report compilations of (R&D)development data?
counter :- since compilations are ih requirement; and raw data and final document is controlled(part-11); compilations need not be subjected to part-11 requirements.
our argument :- as the summary document is basis for submission documentation; this would be under purview of electronic documentation; and further it would have to meet requirements of hybrid system.