Development Data - Part 11 for report compilations excerpts of which filed to FDA

v9991

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#1
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.
 
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v9991

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#2
similar situation can also be visualized in manufacturing environment, viz., LIMS would provide compilation of trends/lists of numbers; its then compiled and translated into graphs, which get included in the annual product review;

Now, does the trends/lists --> compilations/graphs are subject to part -11?
 
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