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Risk Management in Matrix Quality

Manage risk across your quality system — embedded within modules like Supplier, Change Control, and CAPA, or as a standalone company risk register. Built for life sciences and medical device compliance.

Matrix Quality
The challenge
Our solution

Risk management that lives outside the quality system is hard to maintain and audit

Risk management embedded across your quality system — and as a standalone register

  • Risk is disconnected from quality activities

    • When risk assessments sit in standalone spreadsheets, links between risks and quality events, supplier issues, or changes are maintained manually — if at all.

  • Embedded risk in quality modules

    • Risk assessments are built into Supplier Management, Change Control, CAPA, and other modules — so risk is captured at the point of decision, not retrospectively.

  • No consistency across the organisation

    • Different teams use different formats and criteria, making it impossible to aggregate risk at a company level.

  • Company risk register

    • A standalone risk register gives leadership a consolidated view of company-level risks, with full traceability to the underlying quality activities.

  • Risk registers go stale

    • Without integration into daily quality workflows, risk registers are updated infrequently and rarely reflect the current state of the business.

  • Consistent risk criteria across the organisation

    • Define your risk scoring methodology once, and it applies consistently across all modules and teams.

    The challenge

    Risk management that lives outside the quality system is hard to maintain and audit

  • Risk is disconnected from quality activities

    • When risk assessments sit in standalone spreadsheets, links between risks and quality events, supplier issues, or changes are maintained manually — if at all.

  • No consistency across the organisation

    • Different teams use different formats and criteria, making it impossible to aggregate risk at a company level.

  • Risk registers go stale

    • Without integration into daily quality workflows, risk registers are updated infrequently and rarely reflect the current state of the business.

    Our solution

    Risk management embedded across your quality system — and as a standalone register

  • Embedded risk in quality modules

    • Risk assessments are built into Supplier Management, Change Control, CAPA, and other modules — so risk is captured at the point of decision, not retrospectively.

  • Company risk register

    • A standalone risk register gives leadership a consolidated view of company-level risks, with full traceability to the underlying quality activities.

  • Consistent risk criteria across the organisation

    • Define your risk scoring methodology once, and it applies consistently across all modules and teams.

    Core capabilities

    Risk management that works with your quality system, not alongside it.

    Embedded risk in quality modulesRisk assessments are integrated directly into Supplier Management, Change Control, CAPA, and other quality workflows — capturing risk at the point of decision.

    • Supplier risk assessment in qualification workflow

    • Change risk assessment in change control

    • Risk scoring linked to CAPA priority

    Company risk registerA standalone, organisation-level risk register for tracking strategic and operational risks — with links to the underlying quality events and activities that inform them.

    • Centralised company risk register

    • Link risks to quality events, suppliers, and changes

    • Management review-ready risk reporting

    Configurable risk criteriaDefine your own risk scoring methodology, probability and severity scales, and acceptability thresholds — applied consistently across all modules.

    • Custom probability and severity scales

    • Configurable risk score formulas

    • Consistent criteria across all teams and modules

    Risk reporting and visibilityTrack risk levels over time with dashboards and exportable reports. Always know your risk landscape before an audit or management review.

    • Risk dashboard with live data

    • Trend tracking over time

    • Exportable reports for management review

    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