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🔧 MasterControl Quality Management System

MasterControl Quality Management System

The #1 QMS for Life Sciences and Regulated Industries.

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Overview

MasterControl provides a comprehensive, cloud-based Quality Management System (QMS) designed to help regulated companies streamline and manage quality and compliance processes. The platform connects quality throughout the entire product development lifecycle, from concept to commercialization. It offers solutions for document control, training management, audit management, CAPA, and more, ensuring compliance with standards like FDA 21 CFR Part 11 and ISO 9001.

✨ Key Features

  • Audit Management
  • CAPA (Corrective and Preventive Action)
  • Document Control
  • Training Management
  • Supplier Quality Management
  • Risk Management
  • Change Control
  • Nonconformance Management

🎯 Key Differentiators

  • Deep focus on life sciences and regulated manufacturing
  • Integrated platform covering the entire product lifecycle
  • Strong validation and compliance expertise

Unique Value: Provides a single source of truth for quality, connecting all aspects of the product lifecycle to ensure compliance and accelerate product delivery.

🎯 Use Cases (5)

Internal and external audits Supplier audits Regulatory compliance audits (FDA, ISO) Managing nonconformances and deviations Employee training and certification tracking

✅ Best For

  • FDA 21 CFR Part 11 compliance
  • ISO 9001 and ISO 13485 compliance
  • GMP/GxP compliance

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Very small businesses with minimal compliance needs
  • Industries with no regulatory oversight

🏆 Alternatives

Veeva Systems Sparta Systems (TrackWise) ETQ ComplianceQuest

Offers a more comprehensive and integrated suite of quality management tools specifically tailored for regulated environments compared to more generic QMS solutions.

💻 Platforms

Web iOS Android

✅ Offline Mode Available

🔌 Integrations

ERP systems PLM systems CRM systems MES systems LIMS

🛟 Support Options

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

🔒 Compliance & Security

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

💰 Pricing

Contact for pricing
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