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HoldField

QMS demo · deterministic product illustration

Environmental excursion → deviation-ready evidence.

A cleanroom excursion drafts a deviation over the affected batch window and routes it to QA — never auto-closed.

Evidence sealedQA approval requiredGaps remain
Open present mode
Signal detected · 1 / 6A cleanroom sensor crosses a limit and raises a quality signal over the affected window.
Use ← / → to step, 1–6 to jump, space to play or pause.

Evidence path

Environmental tracependingEquipment recordpendingInvestigation notependingTraining recordpendingQA signaturepending

QMS records prepared

Records are prepared once evidence is sealed.

QA approval requiredNot yet reached

The system drafted a deviation and an investigation packet over the affected window.

  • Approver: QA reviewer
  • Human approval required before any disposition.
  • No automatic disposition.

A deviation is never auto-closed. QA approves before it advances; the investigation stays human-led.

GMP readiness view

Gaps remain
  • Deviation evidence — evidence completeTrace, equipment, and batch context bound to the deviation.
  • Part 11 signature view — evidence completeSignature attributable, timestamped, and bound to the record.
  • ICH Q9 risk view — evidence completeRisk assessment attached to the investigation.
  • Investigation close-out — gap remainsRoot-cause close-out is pending QA sign-off.

A GMP readiness view — evidence and gaps side by side, not a claim of GMP certification.

Deterministic product illustration. Regulated decisions remain human-controlled. HoldField is GMP-aware, not a certification; QA owns the deviation and CAPA decisions.

QMS story: Deviations, evidence, and approvals without burying QA in forms

Show deviations, evidence, and approvals without burying QA in forms.

  1. Step 1 of 6 — Signal detected. A cleanroom sensor crosses a limit and raises a quality signal over the affected window.
  2. Step 2 of 6 — Evidence sealed. Sensor trace, equipment record, and the affected batch context are bound and sealed.
  3. Step 3 of 6 — QMS record prepared. A deviation is drafted with an investigation packet and a CAPA / change-control draft.
  4. Step 4 of 6 — Human decision required. QA approval is required before the deviation advances — no automatic disposition.
  5. Step 5 of 6 — Signature recorded. QA records a signature; the deviation becomes a controlled record.
  6. 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.