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Audit & CAPA

Plan, conduct and report audits, track findings from raising to verified closure, and manage corrective and preventive action from any source.

Audits

Plan, conduct and report internal audits against the standards and clauses in scope.

Standards: ISO 9001 §9.2; ISO 19011
What it includes (5 capabilities)
  • Scheduling and team roles
  • Checklists and evidence
  • Department and location tagging
  • Report workflow
  • Report download log

Audit Programme

Agree the year's audit programme up front and generate each audit from it automatically.

Standards: ISO 9001 §9.2.2 a); ISO 19011 §5
What it includes (4 capabilities)
  • Annual plan with approval
  • Recurring entries expanded per interval
  • Standard and clause coverage
  • Lead-time automatic audit generation

Findings

Track every nonconformity and observation from raising to verified closure, with root cause and corrective action.

Standards: ISO 9001 §10.2
What it includes (6 capabilities)
  • Five severities
  • Assignment and due dates
  • Root cause analysis
  • CAPA actions
  • Effectiveness verification
  • Aging report

CAPA Cases

Manage corrective and preventive action arising from any source, not only audits.

Standards: ISO 9001 §10.2
What it includes (6 capabilities)
  • Standalone triage
  • Investigation team
  • RCA
  • Plan and actions
  • Effectiveness check
  • Closure

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