Hi All,
Do the requirements of Part 11 apply to electronic documents…so do you need to audit trail the creation, deletion and modification of electronic documents?
Regards
[quote=gokeeffe]Hi All,
Do the requirements of Part 11 apply to electronic documents…so do you need to audit trail the creation, deletion and modification of electronic documents?
Regards[/quote]
Graham,
I think that is a very good question. Usually when referring to when Part 11 applies or doesn’t apply we refer back to the predicate rules. I would say it would depend on the document and what it contains/used for.
I would love to hear other opinions on this matter as well.
I have scenario, development data is compiled into summary reports (Inhouse purpose), and excerpts 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 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.
question again - development data has to be part-11 compliant (if handled electronically) but, is part-11 a requirement for compilations/reports?
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?