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Qualio

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Cloud eQMS and compliance platform built exclusively for life sciences companies.

Corrective And Preventive Action Software Quality Management Software
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  • Deployment Cloud Based
  • Starting price Custom
  • Free trial Not offered
  • Best for Startups, SMEs, Enterprises

What is Qualio?

Qualio is a cloud-based electronic quality management system built exclusively for life sciences companies, including medical device, pharmaceutical, biotech, and digital health organizations. It manages document control, training, CAPA, change control, supplier management, risk management, and design controls, with pre-configured templates aligned to FDA 21 CFR Part 11, ISO 13485, EU MDR, MDSAP, GxP, and ICH Q10.

Qualio offers three plans, Foundation, Growth, and Scale, distinguished mainly by the number of included edit users (5, 10, and 20 respectively) and available integrations; basic users are unlimited on every plan. Qualio does not publish prices publicly and requires a discovery call for a custom annual quote, plus a separate implementation fee.

Key Features of Qualio

Qualio lists 10 documented features, including Document control, Training management and CAPA management. The list below covers what the product does rather than how it is marketed.

  • Document control
  • Training management
  • CAPA management
  • Change control
  • Supplier management
  • Risk management
  • Design controls with Jira integration
  • Pre-configured FDA and ISO compliance templates
  • AI-powered gap analysis and compliance intelligence
  • Unlimited basic (read-only style) users on every plan

Qualio Pricing

Qualio lists 3 plans without published figures. Pricing is quoted on request.

Foundation

Custom

5 edit users, unlimited basic users

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For teams formalizing quality management for the first time; includes SSO, OneDrive, and Jira.

Growth

Custom

10 edit users, unlimited basic users

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Most popular plan; adds the full integration catalog including CRM and support tools, plus AI assistance.

Scale

Custom

20+ edit users, unlimited basic users

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For mature quality operations with enterprise-grade complexity; custom implementation and dedicated support.

Qualio Specifications

Qualio is available on web app. It offers an API.

Deployment
  • Cloud Based
Billing cycle
Yearly
Desktop
  • Web App
Languages
  • English
Built for
  • Startups
  • SMEs
  • Enterprises
Support
  • Email
  • Live Support
  • Training
  • Tickets
Integrations
Jira, OneDrive, SSO, and additional CRM/support tools via Integration Hub
Public API
Yes
Free trial
No
Free plan
No
Runs in browser
Yes
Customisable
Yes
Website
qualio.com

Qualio Videos

Qualio Screenshots

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Qualio FAQs

Qualio offers three plans: Foundation, Growth, and Scale, differentiated mainly by the number of included edit users and available integrations.

No, Qualio requires a discovery call and provides a custom quote for each plan.

Qualio is built specifically for life sciences companies, including medical device, pharmaceutical, biotech, and digital health organizations.

Basic users are unlimited on all plans at no extra cost; only edit user counts are capped by plan.

It supports FDA 21 CFR Part 11, ISO 13485, EU MDR, MDSAP, GxP, and ICH Q10, among others.