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MasterControl Manufacturing Excellence

by MasterControlmastercontrol.com
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OVERVIEW

A next-generation digital manufacturing execution system (MES) for life sciences, digitizing production records (EBR/eDHR) to accelerate product release and ensure GxP compliance.

MasterControl Manufacturing Excellence (Mx) is a modern, cloud-based Manufacturing Execution System (MES) designed for life sciences organizations, including pharmaceutical, medical device, and dietary supplement manufacturers, to achieve paperless, errorless, and frictionless production.

It digitizes and automates the "last mile" of the manufacturing process, replacing error-prone paper-based records (travelers, batch records, DHRs) with Electronic Batch Records (EBR) and Electronic Device History Records (eDHR). The platform helps eliminate millions of errors and can accelerate product delivery by up to 70%. Key capabilities include rapidly digitizing manufacturing processes with no-code workflows, automating production processes, and orchestrating resources.

Key Capabilities:

  • Digital Production Records: Provides 100% paperless data input and documentation for EBR/eDHR.
  • In-line Quality Control: Embeds operator guidance, training, built-in controls, and alerts to eliminate production errors in regulated environments.
  • Accelerated Release: Enables smart, real-time review-by-exception for faster product review and release.
  • Asset Management: Digitalizes equipment and facilities logbooks for audit readiness, ensuring GMP compliance and providing real-time visibility into asset status.

It integrates with systems like ERP, LIMS, and QMS, as well as assets like scales, scanners, equipment, and IoT devices, providing real-time operational visibility through robust analytics and in-process dashboards. Target users span manufacturing operations leadership, line supervisors and operators, quality assurance (QA) and quality control (QC) teams, and IT.

RATING & STATS

User Rating
4.3/5.0
140 reviews
Customers
1,000+
Founded
1994

SCREENSHOTS

MasterControl Manufacturing Excellence screenshot 1MasterControl Manufacturing Excellence screenshot 2

KEY FEATURES

  • 100% Digital Production Records (EBR/eDHR)
  • Review-by-Exception
  • Digital SOPs and Work Instructions
  • In-line Quality Controls and Alerts
  • Electronic Logbooks and Asset Management
  • Automated Data Capture and Conditional Pathing
  • Real-time Data Management and Analytics
  • Seamless QMS/MES Integration

PRICING

Model: subscription
Custom, subscription-based pricing tailored to the organization's needs, including selected modules, number of users, and deployment preferences. Contact sales for a quote.

TECHNICAL DETAILS

Deployment: cloud, on_premise, hybrid, saas
Platforms: web
📱 Mobile Apps🔌 API Available

USE CASES

Eliminating paper-based batch records and DHRsEnsuring GxP compliance and audit readinessAccelerating product review and release cyclesManaging equipment calibration and maintenanceStreamlining quality processes across manufacturing

INTEGRATIONS

SAP ECCSAP HANA CloudERPLIMSQMSIoT devices

COMPLIANCE & SECURITY

Compliance:
FDA 21 CFR Part 11FDA 21 CFR Part 210-211 (cGMP)FDA 21 CFR Part 111GxPISO
Security Features:
  • 🔒Audit Trails
  • 🔒User Access Controls
  • 🔒Two-Factor Authentication (Two-Password Approval)
  • 🔒Encryption
  • 🔒Account Lockout

SUPPORT & IMPLEMENTATION

Support: email, phone, live chat
Implementation Time: 1-3 months
Target Company Size: startup, small, medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Designed specifically for the Life Sciences industry and GxP compliance
  • +Accelerates product release through Review-by-Exception
  • +High ease of use for operators (G2 score 8.6/10)
  • +Eliminates paper-based errors and manual data entry
  • +Seamless integration with MasterControl QMS and other enterprise systems (ERP, LIMS)
✗ Cons:
  • -Exact pricing details are not publicly disclosed (custom quote only)
  • -Some users report reports are not user-friendly or require additional work
  • -Can be difficult to find the proper view when opening a record
  • -System upgrades sometimes bring unexpected issues

TRY IT OUT