MasterControl Manufacturing Excellence
by MasterControl · Manufacturing (MES / PLM)
Cloud MES and electronic batch records platform for regulated life sciences manufacturers.
- Works with
- SAP, Oracle
- Deployment
- Cloud
- Pricing
- Quote-based
- Headquarters
- Salt Lake City, Utah, United States
Overview
MasterControl Manufacturing Excellence (Mx) is a cloud-based Manufacturing Execution System (MES) built for life sciences manufacturers -- pharmaceutical, medical device, biologics, cell and gene therapy, dietary supplement and food & beverage companies -- that need to replace paper-based production records with a validated, GMP-compliant digital workflow.
The platform's core is Electronic Batch Records (EBR) and Electronic Device History Records (eDHR): no-code digital work instructions with embedded operator guidance, automated data capture, conditional pathing, and review-by-exception to speed batch release. It extends into electronic logbooks for equipment and facilities, and Regulated Asset Management (RAM) for calibration and maintenance tracking tied to GMP compliance.
MasterControl positions Mx as the connective layer between shop-floor execution and the rest of the regulated enterprise, integrating with ERP systems (including SAP and Oracle), LIMS, and QMS platforms -- including its own MasterControl Quality Excellence eQMS -- via an Integration Platform as a Service (iPaaS) approach, so operators can pull product and material master data from ERP directly onto production tablets and push completed batch and quality data back for a unified production and compliance record.
Screenshots & demo
Demo video from the vendor's YouTube channel.
Features & capabilities
Manufacturing Execution (MES)
Core production orchestration for regulated manufacturing lines.
- No-code workflow builder for digitizing production processes
- Recipe, formulation and product family management
- Automated production process orchestration
- Real-time operational dashboards and analytics
- Shop-floor tablet data entry
Electronic Batch Records & eDHR
Digital replacement for paper batch records and device history records.
- Digitized GMP work instructions with embedded operator guidance
- Automated data capture and conditional pathing
- Dynamic in-process controls with real-time alerts
- Review-by-exception for faster batch/device record release
- Automated quality event and deviation triggering
Electronic Logbooks
Digitized equipment and facility logbooks with GMP audit trails.
- Equipment and facilities logbook digitalization
- Automated data exchange with MES and QMS
- GMP-compliant audit trail maintenance
Regulated Asset Management (RAM)
Equipment maintenance, calibration and usage tracking.
- Equipment maintenance and cleaning protocol tracking
- Time-, calendar- and usage-based event triggers
- Calibration and measurement management for compliance
Enterprise Integration
Connectivity layer linking the shop floor to ERP, LIMS and QMS.
- iPaaS-based integration architecture
- ERP master data and production data exchange (SAP, Oracle)
- LIMS integration for lab and quality data
- QMS integration (including MasterControl Quality Excellence)
- Connectivity to scales, scanners, equipment and IoT devices
Common use cases
- Replacing paper batch records and travelers with validated Electronic Batch Records for pharmaceutical or biologics production
- Digitizing Device History Records (eDHR) for medical device manufacturers under FDA/ISO requirements
- Pulling product and material master data from an ERP system directly onto shop-floor tablets to eliminate manual re-entry
- Feeding completed batch, yield and quality data back into SAP or Oracle ERP for a unified production and financial view
- Digitizing equipment and facility logbooks to maintain GMP audit trails across a plant
- Tracking calibration and preventive maintenance schedules for regulated production equipment
- Connecting MES quality events directly into a QMS for review-by-exception and faster deviation resolution
Strengths & considerations
Strengths
- Purpose-built for regulated life sciences manufacturing (pharma, medical device, biologics, cell & gene therapy) rather than general discrete/process manufacturing
- No-code workflow authoring for EBR/eDHR, reducing dependency on IT for validation-impacting changes
- Native adjacency to MasterControl's own QMS (Quality Excellence) and LIMS integrations for a connected quality-to-production data chain
ERP integrations
Pricing
Named-user, per-module licensing; packages range from pre-configured/pre-validated setups for smaller companies to comprehensive enterprise packages. No public starting price listed; contact MasterControl sales for a quote. Get an independent shortlist with pricing guidance below.
Technical & security
- Hosting
- SaaS (cloud-based, validated deployment)
- Compliance
- FDA, ISO, GMP
About the vendor
- Headquarters
- Salt Lake City, Utah, United States
Alternatives to MasterControl Manufacturing Excellence in Manufacturing (MES / PLM)
MasterControl Manufacturing Excellence — frequently asked questions
Does MasterControl Manufacturing Excellence integrate with SAP?
Yes. MasterControl integrates with SAP ERP through an iPaaS-based integration, exchanging product and material master data with SAP and feeding completed production and quality data back for a unified view.
What is the difference between MasterControl MES and an ERP system?
MasterControl's Mx is a Manufacturing Execution System focused on shop-floor production, batch records and quality events, while an ERP oversees broader functions like supply chain, order processing, inventory and finance. Mx is designed to integrate with, not replace, an existing ERP.
What industries use MasterControl Manufacturing Excellence?
It is used primarily by regulated life sciences manufacturers, including pharmaceutical, medical device, biologics, cell and gene therapy, dietary supplement, and food and beverage companies.
How much does MasterControl Manufacturing Excellence cost?
Pricing is quote-based and licensed per named user, with packages ranging from pre-configured setups for smaller companies to comprehensive enterprise packages. MasterControl does not publish a starting price; contact their sales team for a customized quote.
Evaluating Manufacturing (MES / PLM)?
Tell us your ERP and requirements and we'll send an independent shortlist — including MasterControl Manufacturing Excellence and the best-fit alternatives — with honest pros and cons.