Quality Excellence (Qx)

MasterControl Quality Excellence (Qx) is an AI-enhanced quality management system (QMS) trusted by more than 1,100 customers — ranging from startups to global enterprises — in the life sciences industry. Designed to close the loop on quality from end to end, it connects quality event management, document management, and training management into a single, unified platform that helps organizations bring quality products to market faster.

With over 25 years of domain experience, MasterControl delivers a complete digital closed-loop QMS that automates workflows, ensures data connectivity, and scales to fit businesses of all sizes. Flexible buying plans — from Basic Document Management to a Complete Digital QMS — allow organizations to adopt the solution at their own pace.

AI-Enabled Quality Management

• Extensively trained and customized AI models built specifically for the life sciences context.
• Secure platform architecture that ensures data security and integrity throughout all processes.
• Human-in-the-loop design that keeps quality experts in control of AI-assisted decisions.
• AI-generated event summaries and deviation trend identification to accelerate decision-making.
• AI-assisted exam generation that saves 300+ hours annually in training management.
• Automatic document translation and AI-generated change summaries that reduce translation time by 330+ hours.

Flexible Quality Event Management

• No-code form and workflow designer that allows teams to build, modify, and optimize quality event processes exactly as needed.
• Rules-based routing that dynamically automates processes based on conditions and context.
• Native integrations with document management, change controls, training, and exams to ensure a fully closed-loop quality process.
• AI features that provide concise and accurate event summaries and identify deviation trends to save time and support faster decisions.

Simplified Document Management

• Streamlined document creation and approvals with automated version control, eSignatures, and archiving.
• Real-time collaboration tools that ensure teams are always working from current document versions, with automatic change tracking and communication.
• Easily searchable and traceable document repository that is fully compliant with 21 CFR Part 11 requirements.
• Effortless change management supported by AI-generated change summaries and automatic document translation capabilities.

Automated Training Management

• Comprehensive management of all quality training tasks, including scheduling, routing, tracking, follow-up, and escalation.
• Role-based exam delivery with detailed recording and maintenance of every employee's training status and competencies.
• Automatic launch of training and exams triggered by document change control events, CAPAs, and production records.
• AI-assisted exam generation to significantly reduce the time required to build and deploy training content.

Connected QMS System

• Closed-loop architecture that connects quality events, documents, training, change control, audit management, and risk management in one platform.
• Automated workflows that reduce manual effort and ensure consistent process execution across the organization.
• Scalable plans — Basic, Standard, and Complete — tailored to fit the needs and growth stage of any life sciences business.

MasterControl Quality Excellence is built for compliance-driven life sciences environments, supporting regulatory standards including FDA 21 CFR Part 11 and ISO requirements. The platform is backed by an extensive library of resources — including ROI calculators, buyer's guides, and industry research — to help organizations assess, implement, and continuously improve their quality management practices.