Skip to main content
Audits & QMS Governance

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.

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.

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.

More in Audits & QMS Governance

Explore other modules in the Audits & QMS Governance category.