MasterControl Quality Excellence

MasterControl is an advanced quality and compliance management platform that combines document control, training management, and end-to-end quality processes across the value chain. It provides automated document lifecycle workflows with rule-based approvals, version control, audit trails, and regulated compliance support (including FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and GMP). The platform also manages training through role-based assignments, certification tracking, competency assessments, and support for eLearning content via SCORM integration. In addition to document and training management, MasterControl extends across quality operations with modules for statistical process control, deviation and CAPA management, supplier quality monitoring, product quality planning, and customer feedback and regulatory reporting. It integrates with manufacturing and enterprise systems such as ERP, PLM, LIMS, and SCADA through APIs and pre-built connectors. AI capabilities support document translation, summarization, training exam generation, and predictive compliance analytics, all within a secure cloud environment.

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Green QuadrantReport · 2025Green Quadrant: Quality Management System Software 2025View report