Distinct from the submission package
This is the internal, complete programming record, broader than what ships in eSubmission package preparation, which is scoped to what a regulator needs to see.
What's included
Building the permanent record of the programming workstream
- Final production programs, macros, and logs archived alongside the datasets and TLFs they generated
- All specification versions, SDTM mapping, ADaM, TLF programming, retained with their revision history intact
- Independent QC and double-programming records preserved to document how each key output was verified
- Archive organized and indexed to SOP retention requirements, with access controls appropriate for inspection
- A final archival confirmation issued once the full package has been checked for completeness
Ready before an inspector asks
Built on the same discipline described in inspection readiness, so program-to-output traceability doesn't need to be reconstructed under time pressure.