Final completeness check
A last, exhaustive pass over the TMF that treats it as the single artifact an inspector will judge the study by, building on the ongoing process/system audits run during conduct.
What's included
What the final QC audit covers
- A document-by-document completeness check against the study's TMF filing plan
- Quality control of content, dates, versions, and signatures across every filed document
- Reconciliation between the TMF index and what is actually filed, so nothing is missing or misfiled
- Identification and remediation of gaps before the file is considered inspection-ready
- A final sign-off confirming the TMF meets the standard required for archival and inspection
Inspection-ready sign-off
A documented confirmation that the TMF is complete and accurate, giving the sponsor a clean gate before study close out and archival.