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Qualio

The first cloud quality management system for all Life Sciences companies.

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Overview

Qualio is a holistic quality management platform designed for companies in the medical device, pharmaceutical, and biotechnology industries. It provides core QMS processes like document management, design controls, risk management, training, and change control to help life sciences organizations manage compliance with regulations such as FDA 21 CFR Part 11 and ISO 13485.

✨ Key Features

  • Document Management
  • CAPA Management
  • Training Management
  • Audit Management
  • Change Control
  • Supplier Management
  • Risk Management
  • 21 CFR Part 11 Compliant E-Signatures

🎯 Key Differentiators

  • User-friendly interface designed for ease of use.
  • Focus on startups and scaling life sciences companies.
  • Integrated training and document management.

Unique Value: Simplifies quality management for growing life sciences companies, making compliance accessible and less burdensome.

🎯 Use Cases (4)

Managing SOPs and quality records Automating training and CAPA workflows Preparing for FDA and ISO audits Streamlining document control for 503B facilities

✅ Best For

  • Used by over 600 life science organizations for quality management and compliance.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • May lack advanced equipment and calibration modules needed by large-scale manufacturing.

🏆 Alternatives

MasterControl Greenlight Guru Veeva

More intuitive and faster to implement than larger, more complex enterprise systems, while being more robust and compliant than generic document tools.

💻 Platforms

Web

🛟 Support Options

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

🔒 Compliance & Security

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

💰 Pricing

Contact for pricing
Visit Qualio Website →