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🔧 MasterControl Quality Excellence

MasterControl Quality Excellence

Connecting quality and manufacturing for accelerated product development.

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Overview

MasterControl is a well-established QMS platform used extensively by pharmaceutical, biotech, and medical device companies. It offers robust, integrated modules for document control, CAPA, audit management, and training to ensure compliance with FDA and ISO standards.

✨ Key Features

  • Document Control
  • CAPA Management
  • Training Management
  • Audit Management
  • Change Control
  • Supplier Management
  • Risk Management
  • Electronic Batch Records (EBR)

🎯 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)

Automating quality processes in a cGMP environment Managing electronic batch records for 503B facilities Ensuring 21 CFR Part 11 compliance for electronic records Streamlining document approvals and training automation

✅ Best For

  • Widely used in pharma and biotech for its scalability and Part 11 compliance.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Can be inflexible for teams with unique SOPs or rapidly evolving processes.

🏆 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

🔌 Integrations

ERP CRM LIMS PLM

🛟 Support Options

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

🔒 Compliance & Security

✓ HIPAA ✓ BAA Available ✓ GDPR ✓ SSO ✓ FDA 21 CFR Part 11 ✓ ISO 9001 ✓ ISO 13485 ✓ cGMP

💰 Pricing

Contact for pricing
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