Bioequivalence and Bioavailability Forum

Dear Charl,

Archiving study-specific documents is not difficult: you will need to have properly identified archive boxes labelled with the study code, and a list of what document is in which box. There is no rule as to the order in which the documents should be arranged in the boxes, the one and only rule is that you should be able to retrieve everything. Easy.

The difficulty comes with documents common to several studies: freezer temperature records, pipette control records, balance logbooks etc. There you will need to maintain a very good tracking system, first to identify the correct logbook (meaning that for each logbook you should record for which period of time it was used), then in which archive box it is archived. You can have archive boxes containing only e.g. freezer logbooks and other archive boxes containing only e.g. balance logbooks, or boxes with any kind of documents for a given period of time, it doesn't matter long as you know what is in which box.

Otherwise you will have a hard time finding everything if you have to face an audit or an inspection several months or years after your study is completed.

Good luck

Regards
Ohlbe