E6(R3) Sponsor Kit 10 — Records, TMF & Inspection Readiness
E6(R3) Sponsor Kit 10 — Records, TMF & Inspection Readiness
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Being able to find it, prove it was always there, and hand it over when someone asks.
2 procedures, 9 records. Nine expectations here are scored Critical. One of the quieter new ones catches everybody: records reachable only through a portal still have to end up with the party required to retain them (C.2.8).
- Trial Master File structure, completeness review and retention
- Inspection readiness, including the mock inspection and findings log
- Direct access and inspection support records
If your TMF lives partly in a vendor's system that you will lose access to at contract end, read that portal expectation first.
Word and Excel, editable, no macros. Individual Licence.