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Modules/Audit & Compliance/Audit Management
Audit & Compliance

Audit Management

Plan, execute, and track internal and external audits with configurable checklists and finding management. Generate audit reports and ensure every observation is linked to corrective actions for complete regulatory traceability.

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Part of Audit & Compliance

Audit ReportsInspection ReadinessCompliance CalendarManagement ReviewsQuality KPIsCost of QualityPerformance EvaluationsContracts ManagementQuality Events

Regulatory Context

ISO 13485:2016 §8.2.2 — Internal audit
FDA 21 CFR Part 820.22 — Quality audit
ISO 19011:2018 — Guidelines for auditing management systems

Key Capabilities

What you get with the Audit Management module.

Annual audit program planning with resource allocation and scheduling
Configurable audit checklists mapped to ISO 13485, EU MDR, and FDA clauses
Real-time finding capture with severity classification and evidence attachment
Automated CAPA generation from audit findings with traceability
Auditor qualification and independence tracking for compliance assurance

Why It Matters

How Audit Management helps your organisation.

Stay audit-ready year-round with a structured audit programme and live tracking
Close findings faster by linking every observation directly to corrective actions
Build a culture of continuous improvement through systematic internal assessments

How It Connects

Audit Managementdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

CAPA ManagementAudit ReportsInspection Readiness

Ready to see Audit Management in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Audit Management works within your specific compliance context.

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More in Audit & Compliance

Explore other modules in the Audit & Compliance category.

Audit Reports

Generate professional, regulatory-compliant audit reports with consolidated findings, observations, and recommendations. Streamline report creation with structured templates that ensure consistency and completeness across all your audit activities.

Inspection Readiness

Stay prepared for regulatory inspections at all times with a centralized readiness dashboard and structured preparation checklists. Identify gaps before inspectors arrive and ensure your team is confident, organized, and audit-ready.

Compliance Calendar

Never miss a regulatory deadline with a centralized compliance calendar that tracks all your quality system activities, submissions, and renewal dates. Get proactive notifications and maintain visibility into upcoming obligations across your entire organization.

Management Reviews

Conduct structured management reviews with comprehensive input data aggregation and output tracking. Meet ISO 13485 management review requirements with pre-built agendas, automated data collection, and documented action items that drive continuous improvement.

Quality KPIs

Define, track, and report on key quality performance indicators that give leadership clear visibility into quality system health. Drive data-informed decisions with real-time dashboards and trend analysis across all quality processes.

Cost of Quality

Quantify and track the financial impact of quality activities, failures, and improvements across your organization. Make the business case for quality investments by measuring prevention costs, appraisal costs, and failure costs with clear, actionable metrics.