Platform · Quality Management

Quality events that keep their context

Deviations, NCRs, CAPAs, and change controls as first-class, configurable workflows — raised inside the work that caused them.

What it does

  • Configurable event types and state machines
  • Escalation timelines and QA review gates
  • Linkage to projects, documents, and steps
  • Investigation and CAPA pathways your process defines
  • Evidence packages for inspection readiness
Deviation investigation screen showing state machine progress, investigation notes, linked Master Batch Record document, proposed CAPA, and engineering run context within a tech transfer project.
Quality event in context — deviation linked to document, CAPA, and batch inside the transfer.

What’s configurable

Event types, statuses, transitions, required fields, approval routing, escalation rules, and which project modes an event type applies to.

How it connects

Events reference projects and document versions. Workflows enforce transitions. Audit trail and reporting consume the same objects.

Compliance behaviors

State changes are immutable in the audit trail. Approvals can require re-auth and intent. Access is role-evaluated per object type.

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