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🔧 MasterControl Manufacturing Excellence

MasterControl Manufacturing Excellence

The only platform life science leaders trust for integrated quality, manufacturing, and asset management.

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Overview

MasterControl Manufacturing Excellence is a comprehensive solution designed for regulated industries, particularly life sciences. It replaces paper-based batch records with a fully digital system, enabling review by exception, reducing documentation errors, and accelerating product release. The system is designed to enforce GMP compliance and integrate seamlessly with quality management processes.

✨ Key Features

  • Electronic Batch Records (EBR)
  • Review by Exception
  • Good Manufacturing Practice (GMP) Enforcement
  • Error-Proofing and Data Integrity
  • Integration with Quality Management System (QMS)
  • Real-time Production Monitoring
  • Electronic Signatures (21 CFR Part 11 compliant)

🎯 Key Differentiators

  • Deeply integrated with a comprehensive QMS platform.
  • Focus on life sciences and regulated manufacturing.
  • AI-powered workflows to simplify GxP processes.

Unique Value: A single, unified platform for quality and manufacturing that accelerates product release while ensuring stringent compliance.

🎯 Use Cases (4)

Pharmaceutical Manufacturing Medical Device Manufacturing Biotechnology Production Cell & Gene Therapy

✅ Best For

  • Transitioning from paper-based batch records to a fully digital EBR system.
  • Improving GMP compliance and data integrity on the shop floor.
  • Accelerating batch review and product release cycles through review-by-exception.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Discrete manufacturing outside of regulated industries
  • Very small-scale operations not requiring stringent regulatory compliance

🏆 Alternatives

Veeva Systems Siemens Opcenter Honeywell Tulip

Unlike point solutions, MasterControl provides a holistic view by integrating EBR directly with document control, training, and quality event management.

💻 Platforms

Web API

🔌 Integrations

ERP LIMS QMS API

🛟 Support Options

  • ✓ Email Support
  • ✓ Live Chat
  • ✓ Phone Support
  • ✓ Dedicated Support (Enterprise tier)

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ FDA 21 CFR Part 11 ✓ EU Annex 11 ✓ ISO 9001 ✓ ISO 13485

💰 Pricing

Contact for pricing
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