Per lot: certificate of analysis covering cell count, viability, purity, sterility, mycoplasma, endotoxin and donor serology; donor demographic and eligibility sheet; redacted ethics approval and informed consent form; chain-of-custody record; and the shipping temperature log. Per study: the approved protocol and any amendments, reagent and lot traceability, raw FCS and Excel data, analyzed results with the gating strategy, deviation log, and a signed final report. Files are delivered in editable formats so they can drop straight into your eCTD or internal QA file.
