Qualtrax

Simplify compliance. Ensure quality.

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Overview

Qualtrax is a comprehensive compliance management software that helps organizations streamline document control, automate business processes, and ensure adherence to regulatory standards. It is designed to reduce risk, simplify audits, and maintain quality standards across various industries.

✨ Key Features

  • Document Control
  • Workflow Management
  • Accreditation Management
  • Audit Management (Internal & External)
  • Corrective and Preventive Actions (CAPA)
  • Training Management
  • Risk Management
  • Testing and Validation

🎯 Key Differentiators

  • Focus on a wide range of highly regulated industries beyond just life sciences.
  • User-friendly interface compared to some larger competitors.

Unique Value: Provides a single, unified platform for managing all aspects of quality and compliance, from documents to processes and training.

🎯 Use Cases (4)

Managing documentation to meet compliance needs Automating processes like CAPAs and change control Preparing for and managing internal and external audits Tying documents and processes to specific accreditation requirements

✅ Best For

  • Simplifying the organization and updating of documentation
  • Reducing audit preparation time significantly
  • Implementing process-based risk management

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies seeking a broad enterprise risk management (ERM) platform

🏆 Alternatives

MasterControl TrackWise Qualio

Offers more flexibility and a broader industry focus than some niche competitors, with a strong emphasis on automating workflows.

💻 Platforms

Web

✅ Offline Mode Available

🛟 Support Options

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

🔒 Compliance & Security

✓ HIPAA ✓ BAA Available ✓ SSO ✓ ISO 17025 ✓ ISO 9001 ✓ FDA 21 CFR Part 11

💰 Pricing

Contact for pricing
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