Readiness Gaps

This file tracks high-value validation steps that need external people, operating systems, or licensed tools.

Generated data are workflow fixtures only. They are not for clinical inference, dose selection, or regulatory model qualification.

Current Status

Item Status Why it remains open Evidence or next action
README-only user test Needs independent tester Codex can run commands, but cannot substitute for a third-party first-use read-through Ask a tester to use only README.md and fill docs/USER_TEST_REPORT_TEMPLATE.md
Windows real-machine PowerShell smoke Covered by CI, needs real user environment GitHub Actions checks Windows behavior, but not a local Windows shell with user-installed tools Run .\scripts\harness-check.ps1 -SkipExternalProbe and .\scripts\acceptance-check.ps1 -SkipExternalProbe on Windows
Phoenix execute validation Needs licensed Phoenix environment The repository intentionally does not bundle external tools or licenses Configure external_validation/tool_profiles.yml and run tools/run_external_tool_validation.py --execute
NONMEM execute validation Needs licensed NONMEM environment Probe-only checks cannot confirm a production nmfe run Configure the NONMEM command and run the external validation profile with --execute
nlmixr2 execute validation Needs R/nlmixr2 environment suitable for package compilation and execution Repository smoke checks can verify parser fixtures, not full estimation workflows Run external validation with --tools nlmixr2 --execute
Value-level source review Machine-readable provenance exists, exact value-to-source mapping still needs human review Existing source URL lists do not always identify which source supplied each CL/V/t_half value; a small number of t_half fields now resolve to source IDs Run python tools/check_value_provenance.py . --report, review warning-drug source_id: null entries, and replace only when the exact source can be verified

Local Evidence Already Available

  • make harness-check covers library integrity, pytest, regeneration checks, example checks, downstream smoke, site adapter generation, and external validation probe.
  • python tools/check_value_provenance.py . verifies warning-drug CL/V/t_half provenance schema, canonical normalized values, source-id resolution for non-null IDs, and acknowledged t_half fixture limitations.
  • GitHub Actions runs Ubuntu harness checks and Windows PowerShell smoke checks.
  • Release notes should record which of the external items above were completed for each release.