DOCS · GUIDE

CAPA Lens.

Manage CAPA stages and complaint decisions with human-gated AI assistance.

Complaint intake

Capture manufacturing complaint facts without unnecessary consumer details. AI triage proposes classification, severity, containment, recurrence signals, and whether CAPA consideration is warranted.

  1. Record the complaint.
  2. Request triage.
  3. Accept or edit fields.
  4. Record CAPA required, not required, or pending with rationale.

CAPA closure

A user—not AI—owns transitions and closure. Closure requires completed stage evidence and a recorded effectiveness result.

Current limitations

  • AI cannot create, transition, verify, or close a CAPA.
  • CAPA Lens is beta pending real-data end-to-end validation.

FMEA · Escalations · Playbooks and SOPs