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Quality Events and CAPA in Matrix Quality

Quality issues come in many forms. Matrix Quality handles them through configurable modules you can shape to fit your processes — one Quality Event module with Type-based differentiation, or separate modules for each workflow type. Either way, every issue is logged, investigated, and closed with a full audit trail.

Matrix Quality
The challenge
Our solution

Quality issues managed in disconnected systems are hard to track and harder to audit

Flexible, configurable quality event workflows — all connected, all traceable

  • No single source of truth

    • Deviations, complaints, CAPAs, and NCRs tracked in separate spreadsheets or email threads make it impossible to see the full picture.

  • One system, multiple workflow options

    • Matrix Quality supports a single Quality Event module with type-based differentiation, or separate modules for deviations, complaints, NCRs, OOS, and CAPAs — configured to how your team works.

  • Audit evidence is difficult to produce

    • Without a structured system, showing regulators that every issue was investigated and resolved takes significant manual effort.

  • Full audit trail on every event

    • Every action, approval, and update is timestamped and attributed. Regulators get a complete, unambiguous record.

  • Workflows vary by customer need

    • Some organisations need one unified Quality Event module. Others need separate modules for each event type. A rigid system cannot accommodate both.

  • Linked investigations and corrective actions

    • CAPAs connect directly to their triggering events, so nothing falls through the cracks.

    The challenge

    Quality issues managed in disconnected systems are hard to track and harder to audit

  • No single source of truth

    • Deviations, complaints, CAPAs, and NCRs tracked in separate spreadsheets or email threads make it impossible to see the full picture.

  • Audit evidence is difficult to produce

    • Without a structured system, showing regulators that every issue was investigated and resolved takes significant manual effort.

  • Workflows vary by customer need

    • Some organisations need one unified Quality Event module. Others need separate modules for each event type. A rigid system cannot accommodate both.

    Our solution

    Flexible, configurable quality event workflows — all connected, all traceable

  • One system, multiple workflow options

    • Matrix Quality supports a single Quality Event module with type-based differentiation, or separate modules for deviations, complaints, NCRs, OOS, and CAPAs — configured to how your team works.

  • Full audit trail on every event

    • Every action, approval, and update is timestamped and attributed. Regulators get a complete, unambiguous record.

  • Linked investigations and corrective actions

    • CAPAs connect directly to their triggering events, so nothing falls through the cracks.

    Core capabilities

    Everything you need to manage quality events from first report to closure.

    Configurable event modulesRun a single Quality Event module and use Type to differentiate deviations, NCRs, complaints, and CAPAs — or establish separate modules per workflow. The system adapts to how your team works.

    • Type-based differentiation within one module

    • Separate modules for deviations, NCRs, OOS, complaints

    • Flexible workflow steps per module type

    Investigation and CAPA managementAssign investigations, track root cause analysis, and link corrective and preventive actions directly to the originating event.

    • Assign investigations with due dates

    • Link CAPAs to triggering events

    • Track escalations and closure evidence

    Complaint handlingManage customer complaints from receipt through investigation and resolution with a full audit trail and regulatory reporting support.

    • Complaint intake and triage

    • Investigation workflow with evidence tracking

    • Regulatory reportability assessment

    Complete audit trailEvery change, approval, and status update is automatically logged with user identity and timestamp — ready for any inspection.

    • Immutable event history

    • User-attributed actions and approvals

    • Exportable audit reports

    Hear from our customers

    Roche

    Matrix Quality gives us a single, validated system for our entire quality process. Audits that used to take weeks of preparation now take days.

    Quality Director, Life Sciences Company

    Matrix One is trusted by 500+ Life Sciences & Medical Device Companies