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🔧 MasterControl Quality Excellence

MasterControl Quality Excellence

The #1 Quality Management System (QMS) in Life Sciences.

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Overview

MasterControl offers a digital quality management software (QMS), Quality Excellence, that automates quality processes throughout the product life cycle. It helps companies in regulated industries like life sciences to comply with regulations (e.g., FDA, ISO), reduce risks, and accelerate time to market. The platform integrates quality management, manufacturing execution (MES), and asset management.

✨ Key Features

  • Document Control
  • Quality Event Management (CAPA, Deviations, Nonconformance)
  • Training Management
  • Audit Management
  • Risk Management
  • Supplier Quality Management
  • Manufacturing Execution System (MES)
  • AI-powered Analytics and Reporting

🎯 Key Differentiators

  • Integrated platform for QMS, MES, and asset management
  • Deep focus on life sciences and regulated industries
  • AI-driven analytics and process optimization

Unique Value: Provides a single, unified platform for quality, manufacturing, and asset management, specifically designed to meet the stringent regulatory requirements of the life sciences industry.

🎯 Use Cases (4)

Compliance with FDA 21 CFR Part 11 and ISO standards Automating paper-based quality processes Managing the entire product lifecycle from development to manufacturing Life sciences, pharmaceuticals, biotech, and medical device manufacturing

✅ Best For

  • Used by over 1,100 customers in life sciences for regulatory compliance and quality management.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Very small businesses not in regulated industries

🏆 Alternatives

Veeva Systems ETQ Sparta Systems

Offers a more comprehensive, integrated solution compared to point solutions that only address specific aspects of quality management.

💻 Platforms

Web Cloud

🔌 Integrations

API Native integrations with document management, change controls, training

🛟 Support Options

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

🔒 Compliance & Security

✓ HIPAA ✓ BAA Available ✓ GDPR ✓ SSO ✓ ISO 42001 ✓ FDA 21 CFR Part 11 ✓ ISO 9001:2015

💰 Pricing

Contact for pricing

Free tier: N/A

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