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AssurX Deviation Management

Automate Your Quality and Compliance Processes.

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Overview

AssurX provides a comprehensive and highly configurable enterprise quality management system (EQMS) designed to automate quality and compliance processes. Its Deviation Management solution enables organizations to capture, investigate, and resolve both planned and unplanned deviations and nonconformances. The platform is known for its flexibility, allowing businesses to configure workflows to match their specific processes. AssurX helps companies in regulated industries maintain compliance, reduce risk, and improve operational efficiency.

✨ Key Features

  • Configurable workflows for deviation management
  • CAPA management
  • Document control
  • Audit management
  • Supplier quality management
  • Risk management
  • Electronic signatures and audit trails

🎯 Key Differentiators

  • Highly configurable platform
  • Strong workflow automation capabilities
  • Broad industry support

Unique Value: Provides a highly adaptable EQMS that can be tailored to the unique quality and compliance processes of any organization.

🎯 Use Cases (5)

Managing planned and unplanned deviations Handling nonconformances and out-of-specifications (OOS) Automating the CAPA process Ensuring compliance with FDA and ISO regulations Managing quality across the supply chain

✅ Best For

  • Pharmaceutical and Life Sciences
  • Medical Devices
  • Manufacturing
  • Energy and Utilities

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Small businesses with limited configuration resources
  • Companies looking for a simple, out-of-the-box solution

🏆 Alternatives

MasterControl TrackWise ETQ Reliance

Offers greater flexibility and configurability compared to more rigid, out-of-the-box QMS solutions.

💻 Platforms

Web API

🔌 Integrations

ERP systems (e.g., SAP, Oracle) MES systems LIMS systems CRM systems API for custom integrations

🛟 Support Options

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

🔒 Compliance & Security

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

💰 Pricing

Contact for pricing

Free tier: N/A

Visit AssurX Deviation Management Website →