Inspection Management
A dedicated quality workflow for managing regulatory inspections — requests, responses, findings and commitments — with recorded qualified-human handoffs governed by your approved procedure. It is on the Verixa roadmap, introduced only after intended use is defined, implementation and verification are complete, and commercial release is approved.
What managing a live inspection demands
Running a regulatory inspection is its own discipline, distinct from being ready for one:
What exists today
Phase 1 already covers the readiness half of the inspection story:
Inspection Readiness vs. Inspection Management: Readiness (live today) is the evidence — the sealed pack you produce when the inspector says “show me.” Management (this page, Phase 2) is the event — running the visit itself. They will share one spine.
Inspection Readiness (live, Phase 1): the sealed, tamper-evident evidence pack assembled from live records — readiness scorecard, exceptions summary, one-click audited export. Inspection Readiness →
Scheduled inspections already anchor official packs: an inspection on the calendar pins the pack’s scope and date, so the evidence you assemble is the evidence for that visit.
Governance on the seal: official packs are dispositioned with an e-signature under a two-person rule — the person who seals cannot be the person who generated — and every compute, preview and seal writes an append-only audit entry.
Deterministic readiness: the readiness scorecard is computed deterministically — there is no AI in the scoring path.
Self-inspection and mock-drill records run today and inform the readiness picture; findings and audit responses are handled as connected records on the Phase 1 spine.
On the Phase 2 roadmap — planned, not yet built
These are the requirements being defined and verified — phrased as intent, not current capability.
The inspection-event lifecycle itself — announcement to close-out, as a bounded workflow with recorded qualified-human handoffs.
Request and response tracking during the visit, with observations captured against the records behind them.
Deficiency responses and commitments eligible for CAPA initiation through recorded handoffs, governed by your approved procedure.
Preparation depth — checklists, SME question banks and lessons-learned — connected to the calendar, drills and readiness scorecard that exist today.
Parts of this capability already run in the product and are moving through verification — which is exactly what the release gate above means: nothing is introduced until intended use is defined, implementation and verification are complete, and commercial release is approved.
Shape this workflow.
Founding partners decide what Phase 2 hardens first — and inspection management is built best by teams who have sat in the front room.