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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 and intuitive interface.
  • Strong focus on startups and scaling life sciences companies.
  • Excellent customer support during onboarding.

Unique Value: Simplifies quality management for life sciences companies, enabling them to bring products to market faster while maintaining compliance.

🎯 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

Greenlight Guru MasterControl Veeva QualityOne

Offers a more modern and user-friendly experience compared to older, more complex enterprise systems, with a focus on ease of implementation.

💻 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 →