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AssurX

Enterprise Quality Management Software.

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Overview

AssurX provides a comprehensive quality management system that helps regulated companies manage processes like CAPA, document control, and audits. The software is designed to be a closed-loop system, connecting various quality processes to drive continuous improvement and ensure compliance with standards like ISO and GxP.

✨ Key Features

  • CAPA Management
  • Document Control
  • Audit Management
  • Change Management
  • Training Management
  • Non-conformance Management
  • Supplier Quality Management

🎯 Key Differentiators

  • Highly configurable workflow engine
  • Closed-loop system integrating multiple quality processes
  • Strong focus on enterprise-level deployments

Unique Value: Provides a tightly integrated, closed-loop quality management system that connects all quality processes to enable continuous improvement and ensure compliance.

🎯 Use Cases (3)

Automating the CAPA process from incident capture to closure Managing documents, changes, and training within a single system Ensuring auditability and compliance for regulated industries

✅ Best For

  • Used by enterprises to resolve quality issues, reduce recalls, and promote continuous improvement.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • May be too complex for small businesses with simple quality management needs.

🏆 Alternatives

MasterControl ETQ Sparta Systems

Offers deep integration capabilities that can launch a CAPA or other quality process from anywhere in the electronic quality chain.

💻 Platforms

Web

🔌 Integrations

ERP CRM PLM LIMS

🛟 Support Options

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

🔒 Compliance & Security

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

💰 Pricing

Contact for pricing
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