Qualio

The all-in-one quality management platform for life sciences.

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Overview

Qualio is a cloud-based quality management system (eQMS) designed specifically for life sciences organizations. It helps teams manage document control, training, CAPAs, complaints, and suppliers in a single, compliant platform. The system is built to comply with FDA, ISO, and other regulatory requirements, making it suitable for medical device, pharmaceutical, and biotech companies.

✨ Key Features

  • Document Management
  • Training Management
  • CAPAs & Nonconformances
  • Design Controls
  • Supplier Management
  • Audit Management
  • Change Control
  • Risk Management

🎯 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 (5)

Medical Device Quality Management Pharmaceutical QMS Biotech Compliance ISO 13485 Compliance FDA 21 CFR Part 11 Compliance

✅ Best For

  • Streamlining document control and employee training for regulated companies.
  • Managing quality events like CAPAs and complaints efficiently.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies outside of the life sciences industry.
  • Organizations that do not require strict regulatory compliance.

🏆 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

🔌 Integrations

Jira Azure DevOps API

🛟 Support Options

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

🔒 Compliance & Security

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

💰 Pricing

Contact for pricing
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