Manufacturing Excellence (Mx)

MasterControl Manufacturing Excellence (Mx) is a next-generation digital manufacturing execution system (MES) designed for life sciences manufacturers — from startups to global leaders — seeking to modernize their production operations. The platform has helped hundreds of manufacturers eliminate millions of errors and bring products to market up to 70% faster by enabling completely paperless manufacturing across production records, electronic logbooks, and asset management.

Mx delivers operational improvement at every stage of production, from inbound materials and work orders through batch execution and review-by-exception, quickly and cost-effectively so organizations can gain and sustain a digital advantage in regulated environments.

Core MES Capabilities

• Rapidly digitize manufacturing processes and procedures using no-code workflows alongside integrated recipe, formulation, and product family tools.
• Increase flexibility and visibility by automating production processes, orchestrating resources seamlessly, visualizing operations, and unlocking actionable data insights.
• Connect operations through integrations with ERP, LIMS, and QMS systems, as well as physical assets such as scales, scanners, equipment, and IoT devices.

Electronic Batch Records (EBR) and eDHR

• Digitalize GMP work instructions and embed operator guidance and training, leveraging built-in controls and alerts to eliminate production errors in regulated environments.
• Error-proof life science manufacturing execution with automated data capture, conditional pathing, dynamic process controls, and real-time limits and alerts for both batch and device production.
• Accelerate product review and release with automated quality events and resolution, enabling smart, real-time review-by-exception for faster time to market.

Electronic Logbooks

• Digitalize equipment and facilities logbooks to ensure GMP compliance and provide real-time visibility into critical activities, conditions, and equipment availability.
• Meet life science regulatory requirements by automating data exchanges, eliminating data integrity issues, and maintaining complete audit trails.
• Seamlessly integrate with MasterControl QMS and MES solutions for connected data flows, real-time status updates, and automated quality workflows in regulated environments.

Regulated Asset Management (RAM)

• Streamline regulated asset management with a comprehensive dashboard displaying asset status and robust filtering for lifecycle events including maintenance, warranty expirations, and change requests.
• Monitor and track equipment maintenance plans from cleaning protocols to complex multi-step procedures, with events triggered by time intervals, calendar dates, or usage metrics to align with equipment or regulatory requirements.
• Improve equipment calibration and measurement accuracy with advanced features designed for life science compliance, ensuring secure and traceable data for audits.

MasterControl Mx is built to support compliance with FDA, ISO, and other life science regulatory standards. The platform integrates natively with MasterControl's broader QMS ecosystem, enabling connected data flows across quality and manufacturing operations and supporting organizations on their journey toward full digital transformation.