Qualio
Qualio is a cloud compliance platform for life sciences that combines quality management, product lifecycle tools, compliance frameworks, and AI-powered comp…
What Qualio is
Qualio is a cloud compliance platform for life sciences that combines quality management, product lifecycle tools, compliance frameworks, and AI-powered compliance intelligence. Its document control features support creating, distributing, and storing quality documents with version control and approval workflows. Other tools cover training management, supplier quality, configurable quality event workflows, reporting and analytics, and design controls. Qualio advertises AI-powered gap analysis to identify documentation gaps against regulatory controls and map existing documents to requirements. Its listed frameworks include FDA, MDR, ISO, and GxP; Foundation includes three frameworks and Growth includes five, with additional frameworks available for an added fee. The company lists more than 20 self-serve integrations, including Jira, OneDrive, Salesforce, HubSpot, GitHub, Zendesk, and Azure DevOps. Growth includes a Developer API for custom integrations and workflow automation. Pricing is available on request, and the plans require an implementation fee. Foundation includes five edit users, unlimited basic users, three frameworks, five quality event templates, and two integrations; Growth includes ten edit users, unlimited basic users, five frameworks, unlimited quality event templates, and up to three integrations.
Good
- Provides version control and document approval workflows
- Includes training and supplier quality management
- AI gap analysis maps documents to regulatory requirements
- Lists more than 20 self-serve integrations
- Growth includes a Developer API
Watch out
- Pricing is available only on request
- Implementation fees apply to Foundation and Growth
- Additional compliance frameworks incur an added fee
- Officially supported browser is Chrome latest version
Who it suits
Qualio is aimed at life sciences teams formalizing quality management, preparing for regulatory submissions, or scaling quality operations. Its plan descriptions also identify mature quality operations as a fit for Scale.
Verdict
Qualio brings document control, quality workflows, and compliance intelligence together for life sciences teams. Pricing and implementation costs require a quote, so plan details and fees need to be confirmed directly.
Plans and prices
From Qualio's own pricing page, checked 4 Oct 2026.
| Plan | Price | What it gives you |
|---|---|---|
| Foundation | Priced on request | 5 included edit users · Unlimited basic users · 3 compliance frameworks · 5 quality event templates · 2 integrations · Annual recurring subscription; request a quote. Implementation fee applies. |
| Growth | Priced on request | 10 included edit users · Unlimited basic users · 5 compliance frameworks · Unlimited quality event templates · Up to 3 integrations · Annual recurring subscription; request a quote. Implementation fee applies. |
| Scale | Priced on request | Enterprise-grade complexity · Multi-site requirements · Custom configuration · Dedicated success and support · Custom pricing and custom implementation; annual recurring subscription model stated for Qualio subscriptions. |
The facts
Each one read from Qualio's own pages, with the date it was checked.
The company
- Company
- Qualio's company page identifies Robert Fenton as founder and CEO, and its press page says the company was founded in 2012.checked 4 Oct 2026
- Founded
- 2012checked 28 Sep 2026
- Headquarters
- Dublin, Irelandchecked 28 Sep 2026
What it does
- Compliance intelligence
- Qualio advertises AI-powered gap analysis that identifies where documentation falls short against regulatory controls and maps existing documents to requirements.checked 4 Oct 2026
- Data protection
- Qualio's security documentation says customer personal data is encrypted at rest using AES-256 or equivalent and its production infrastructure is hosted on AWS.checked 4 Oct 2026
- Developer API
- The pricing page lists a Developer API for building custom integrations and automating workflows programmatically, included with Growth.checked 4 Oct 2026
- Document control
- Document Control supports building, distributing, and storing quality documents with version control and approval workflows.checked 4 Oct 2026
- Frameworks
- The pricing page lists FDA, MDR, ISO, and GxP and says Foundation includes three frameworks and Growth five, with additional frameworks available for an added fee.checked 4 Oct 2026
- Implementation
- Qualio says most customers are live within 30 to 60 days with appropriate preparation from their team.checked 4 Oct 2026
- Integrations
- Qualio says it has 20+ self-serve integrations, including tools such as Jira, OneDrive, Salesforce, HubSpot, GitHub, Zendesk, and Azure DevOps.checked 4 Oct 2026
- Intended customers
- The pricing page positions Foundation for teams formalizing quality management and preparing for a first regulatory submission, Growth for scaling organizations, and Scale for mature quality operations.checked 4 Oct 2026
- Product
- Qualio describes itself as a compliance platform for life sciences combining quality management, product lifecycle, compliance frameworks, and AI-powered compliance intelligence.checked 4 Oct 2026
- Quality workflows
- The platform includes training management, supplier quality management, configurable quality event workflows, reporting and analytics, and design controls.checked 4 Oct 2026
- Security certifications
- Qualio's data processing addendum lists active ISO/IEC 27001, ISO/IEC 27701, ISO 9001, and ISO 42001 certifications.checked 4 Oct 2026
- Support
- The pricing page says its global support team provides weekday chat and email support.checked 4 Oct 2026
Where it runs
- Platform requirements
- Qualio's documented minimum requirements specify cloud access via modern computers and large mobile devices, Windows 10 or Mac OS X, and Chrome latest version as its officially supported browser.checked 4 Oct 2026
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