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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
  • CAPA Management
  • Training Management
  • Audit Management
  • Supplier Quality Management
  • Risk Management
  • Change Control
  • Nonconformance Management
  • Electronic Signatures

🎯 Key Differentiators

  • End-to-end quality and manufacturing solutions on a single platform.
  • Deep focus on life sciences and other highly regulated industries.

Unique Value: Provides a comprehensive, integrated platform that connects quality management with manufacturing execution, enabling true quality at the source.

🎯 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 Qualio ETQ Sparta Systems

Unlike point solutions, MasterControl offers a full suite of interconnected applications, reducing the complexity of managing multiple systems.

💻 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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