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Modules/Change Control/Change Control
Change Control

Change Control

Manage every change to your products, processes, and quality system through a structured, risk-assessed workflow. Ensure all changes are properly evaluated, approved, and implemented with full traceability to affected documents, training, and regulatory submissions.

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Part of Change Control

Configuration ItemsPost-Registration Review

Regulatory Context

ISO 13485:2016 §7.3.9 — Design and development changes
FDA 21 CFR Part 820.30 — Design controls
EU MDR Annex IX — Conformity assessment based on a quality management system

Key Capabilities

What you get with the Change Control module.

Structured change request workflows with impact assessment and risk evaluation
Cross-functional review and approval routing with electronic signatures
Automatic identification of affected documents, processes, and training requirements
Change implementation tracking with verification and effectiveness checks
Complete change history with regulatory-ready audit trail

Why It Matters

How Change Control helps your organisation.

Prevent unintended consequences with structured impact assessment before any change
Maintain full traceability linking every change to affected documents and training
Accelerate time-to-market by streamlining cross-functional change approvals

How It Connects

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

Document ControlConfiguration ItemsRisk Management

Ready to see Change Control in action?

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

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More in Change Control

Explore other modules in the Change Control category.

Configuration Items

Track and manage the configuration of your products, systems, and critical components throughout their lifecycle. Maintain a clear record of what changed, when it changed, and why, ensuring full traceability for regulatory compliance.

Post-Registration Review

Evaluate changes to registered products to determine if regulatory submissions or notifications are required. Streamline your post-registration review process to ensure changes are assessed against global regulatory requirements before implementation.