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Master Control Integration

Unify your risk management and quality workflows with seamless Smart Risk & MasterControl integration.
Our solution connects AI-powered risk analysis with industry-leading QMS capabilities, ensuring your organization maintains full compliance, traceability, and operational efficiency—without doubling work.

Smart Risk automatically generates, updates, and analyzes FMEA data, hazards, mitigations, CAPAs, and design controls using advanced AI models. By integrating directly with MasterControl, this intelligence flows into your document control, change management, CAPA, training, and product lifecycle processes in real time.

Smart Risk Integration into Master Control in minutes not months!

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Key Benefits

  • Single Source of Truth
    Synchronize risk files, FMEAs, design controls, and project documentation automatically between Smart Risk and MasterControl.

  • Real-Time AI-Driven Updates
    When product changes occur in MasterControl, Smart Risk instantly re-evaluates risks, RPN scores, and mitigations—eliminating outdated risk files.

  • Closed-Loop Compliance
    Map design inputs, outputs, verification, validation, hazards, CAPAs, and risk controls with automated traceability links.

  • Automated Change Impact Analysis
    AI identifies affected risks, documents, test cases, and controls every time a change request is initiated.

  • Audit-Ready Documentation
    Export synchronized, version-controlled risk and design-control records aligned with FDA, ISO 13485, and ISO 14971 expectations.

How It Works

  1. Connect your MasterControl environment with Smart Risk via secure API integration.

  2. Import design inputs, outputs, requirements, and risk files.

  3. Analyze risks and traceability automatically using Smart Risk’s AI engine.

  4. Sync all updates back into MasterControl with full version control.

  5. Monitor ongoing compliance with real-time alerts and dashboards.

The Result

A powerful, automated risk-and-quality ecosystem where MasterControl provides robust QMS governance and Smart Risk delivers intelligent, dynamic risk analysis—working together to accelerate development, reduce compliance gaps, and strengthen product safety.

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