Inspection readiness, audit-ready by design.
A working client-facing workflow for life-sciences teams preparing for an FDA inspection and maintaining inspection readiness between windows. Evidence, gaps, CAPAs, mock drills, and a human-only approval queue — every transition stamped on the audit trail the regulator already reads against.
21 CFR Part 11 · HIPAA · FDA QSR literate
Workflow · five stages
Five stages, end-to-end.
Five stages that map one-to-one with the life-sciences inspection-readiness loop: intake the inspection, triage the readiness gaps, lock the evidence, assign the CAPAs, and drill the mock-inspection. Every stage writes one audit row per transition so the regulator sees the same paper trail the QA lead reads.
- StageInspection intake
Scope
Stand up the inspection track — sponsor, program, FDA division, target window, and the reviewer label the audit trail will carry forward.
Outcome
A queued inspection row with the target window logged and the QA lead / consultant label captured as the `actor` for every downstream transition.
Stage 1 of 5 — the inspection is born the moment the trigger arrives. The first audit row captures the inspection metadata plus the reviewer label the workflow will stamp on every transition that follows, so anyone reading the audit log later sees the same paper chain the team reads today.
- StageReadiness triage
Scope
Log every readiness gap with a category (protocol / SOP / TMF / drug-substance / etc.), severity, an owner label, and a description the sponsor auditor can read without context.
Outcome
A live readiness board with gaps tagged open → triaged → in_remediation → remediated → closed, every transition stamped on the audit log.
Stage 2 of 5 — a readiness gap with a category + severity + owner label. The triage workflow runs the gap from open → triaged → in_remediation → remediated → closed; every transition stamped on the audit log the QA lead reads alongside the validation paperwork the sponsor keeps.
- StageEvidence logging
Scope
Catalog every protocol / SOP / deviation / TMF artifact / validation report the inspection needs — type, links to the authoritative TMF artifact, and a per-row version counter.
Outcome
A versioned evidence catalog with the immutable audit row per status transition so a regulator reads the same paper chain at audit that the QA lead reads during inspection prep.
Stage 3 of 5 — every protocol, SOP, deviation, TMF artifact, validation report and other evidence the inspection pivots on lives here. Status flows draft → in_review → approved/rejected, with a version counter and a paired audit row per transition.
- StageCAPA / remediation
Scope
Assign every gap a CAPA / remediation owner with a due date and a description the sponsor side of the existing paper trail can reconstruct against.
Outcome
A live CAPA board keyed to the readiness gaps with one audit row per status transition — submitted_to_review stamps `submittedAt`, approved stamps `approvedAt`, closed stamps `closedAt`.
Stage 4 of 5 — the CAPA / remediation table picks up a readiness gap and gives it a named owner, a due date, and a description the sponsor side of the paper trail can reconstruct. Each transition is a paired audit row the regulator can read.
- StageMock-inspection drill
Scope
Plan, assign, and review a mock-inspection drill per scenario (483 response drill, sponsor / CRO interview drill, validation override drill, etc.) with a due date and the evidence the drill verifies against.
Outcome
A live mock-drill log with scenarios / owners / due dates and a per-action audit row, plus a CAPA-loop back into evidence / gaps / CAPAs when a drill surfaces a new finding.
Stage 5 of 5 — a mock-inspection drill per scenario with a named role, an evidence pointer, and a status track (open → prepared → reviewed → closed). The drill is what loops back into stages 2 / 3 / 4 when it surfaces a new gap, an unpinned evidence item, or a CAPA that needs an owner.
Audit trail
Four artifacts. One immutable log.
The workflow writes four artifact rows an FDA reviewer or internal auditor can read alongside the validation paperwork the sponsor already maintains for the inspection window.
Versioned evidence catalog
Every protocol / SOP / deviation / TMF artifact / validation report the inspection pivots on is logged with a version counter, a typed owner label, and an audit row per status transition.
Readiness-gap taxonomy
Every gap is logged with a category (protocol / SOP / TMF / quality / etc.), a severity band, and a triage arc the sponsor auditor can read with the validation paperwork that already exists.
CAPA / remediation log
Every CAPA / remediation carries an owner label, a due date, a status track including `submitted_to_review` → `approved` / `rejected`, and a paired audit row per transition.
Immutable audit log
Every transition writes one immutable audit row carrying the actor label, the from/to status, and a payload snapshot the regulator can reconstruct against the validation paperwork the sponsor keeps.
Bounded ROI
Inspection prep measured against the same window the sponsor already scopes.
Median time to inspection-ready
ROI is bounded to the inspection-prep window the sponsor already runs before each window — every transition stays anchored to a real readiness artifact, not a new dashboard.
Stand the workflow up
Spin up a new inspection track in one short form.
Five fields. The form writes a queued inspection row, captures your reviewer label, and lands you on the workbench where evidence, gaps, CAPAs, mock actions, approvals and the audit log all live side by side.
Inspection intake
Same workflow the QA team already runs · now audit-stamped.