Signal detected · 1 / 6A cleanroom sensor crosses a limit and raises a quality signal over the affected window.
QMS story: Deviations, evidence, and approvals without burying QA in forms
Show deviations, evidence, and approvals without burying QA in forms.
Step 1 of 6 — Signal detected. A cleanroom sensor crosses a limit and raises a quality signal over the affected window.
Step 2 of 6 — Evidence sealed. Sensor trace, equipment record, and the affected batch context are bound and sealed.
Step 3 of 6 — QMS record prepared. A deviation is drafted with an investigation packet and a CAPA / change-control draft.
Step 4 of 6 — Human decision required. QA approval is required before the deviation advances — no automatic disposition.
Step 5 of 6 — Signature recorded. QA records a signature; the deviation becomes a controlled record.
Step 6 of 6 — Audit packet prepared. An audit packet shows GMP readiness, a Part 11 signature view, and an ICH Q9 risk view.
Approval: The system drafted a deviation and an investigation packet over the affected window. QA reviewer must approve. Human approval required before any disposition. No automatic disposition.
Readiness — GMP readiness view: Deviation evidence (evidence complete); Part 11 signature view (evidence complete); ICH Q9 risk view (evidence complete); Investigation close-out (gap remains). A GMP readiness view — evidence and gaps side by side, not a claim of GMP certification.
HoldField is GMP-aware, not a certification; QA owns the deviation and CAPA decisions.