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Qualio

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What Qualio is

Qualio is a cloud compliance platform for life sciences that combines quality management, product lifecycle tools, regulatory frameworks, and compliance intelligence. Document Control supports quality documents with version control and approval workflows. Other capabilities include training management, supplier quality, configurable quality event workflows, reporting, analytics, and design controls. Qualio advertises AI-powered gap analysis to identify documentation shortfalls against regulatory controls and map existing documents to requirements. 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 programmatic workflow automation. Published security information lists ISO/IEC 27001, ISO/IEC 27701, ISO 9001, and ISO 42001 certifications. The platform is available through web and API. Pricing is on request, and implementation fees apply to Foundation and Growth.

Who it suits

Foundation is positioned for teams formalizing quality management and preparing for an initial regulatory submission; Growth is for scaling organizations. Scale is positioned for mature quality operations with multi-site or enterprise complexity.

What it does well

  • Document control includes versioning and approval workflows
  • AI gap analysis maps documents to requirements
  • More than 20 self-serve integrations are listed
  • Growth includes a Developer API
  • Published security certifications include ISO/IEC 27001

What to know first

  • No free plan is listed
  • Pricing is available only on request
  • Foundation and Growth have implementation fees
  • Additional compliance frameworks cost extra

Limits

Foundation includes five edit users, unlimited basic users, three compliance 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; extra frameworks cost more.

Plans

PlanBilled and limitsPrice
FoundationAnnual recurring subscription; request a quote. Implementation fee applies. · 5 included edit users · Unlimited basic users · 3 compliance frameworks · 5 quality event templates · 2 integrationsOn request
ScaleCustom pricing and custom implementation; annual recurring subscription model stated for Qualio subscriptions. · Enterprise-grade complexity · Multi-site requirements · Custom configuration · Dedicated success and supportOn request
GrowthAnnual recurring subscription; request a quote. Implementation fee applies. · 10 included edit users · Unlimited basic users · 5 compliance frameworks · Unlimited quality event templates · Up to 3 integrationsOn request

As qualio.com lists them, read 4 Oct 2026. The maker's own page has the final word.

Getting started

  1. Open the Qualio website
  2. Request a quote for a subscription plan
  3. Choose Foundation, Growth, or Scale based on your quality operation
  4. Prepare your team for implementation
  5. Access the cloud service from a supported Windows or Mac computer using the latest Chrome

Verdict

Qualio brings quality workflows, document control, frameworks, and compliance intelligence into a cloud platform. Compare the user, framework, and integration allowances by tier, and include implementation fees in planning.

Questions

Is Qualio free?

No. Qualio is a paid service and does not offer a free plan.

How is Qualio priced?

Pricing is available on request. Foundation and Growth use annual recurring subscriptions and have an implementation fee; Scale uses custom pricing and custom implementation.

Which platforms does Qualio support?

Qualio is delivered through the web and API. Its documented requirements specify Windows 10 or Mac OS X, modern computers or large mobile devices, and the latest Chrome browser.

What compliance frameworks are available?

The listed frameworks are FDA, MDR, ISO, and GxP. Foundation includes three frameworks, Growth includes five, and additional frameworks are available for an added fee.

Does Qualio provide integrations?

Yes. Qualio lists more than 20 self-serve integrations, including Jira, OneDrive, Salesforce, HubSpot, GitHub, Zendesk, and Azure DevOps.

Who founded Qualio?

The company identifies Robert Fenton as its founder and CEO and says it was founded in 2012.

Facts from Qualio's own pages

Company
Qualio's company page identifies Robert Fenton as founder and CEO, and its press page says the company was founded in 2012. · qualio.com, 4 Oct 2026
Compliance intelligence
Qualio advertises AI-powered gap analysis that identifies where documentation falls short against regulatory controls and maps existing documents to requirements. · qualio.com, 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. · qualio.com, 4 Oct 2026
Developer API
The pricing page lists a Developer API for building custom integrations and automating workflows programmatically, included with Growth. · qualio.com, 4 Oct 2026
Document control
Document Control supports building, distributing, and storing quality documents with version control and approval workflows. · qualio.com, 4 Oct 2026
Founded
2012 · qualio.com, 28 Sept 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. · qualio.com, 4 Oct 2026
Headquarters
Dublin, Ireland · qualio.com, 28 Sept 2026
Implementation
Qualio says most customers are live within 30 to 60 days with appropriate preparation from their team. · qualio.com, 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. · qualio.com, 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. · qualio.com, 4 Oct 2026
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. · docs.qualio.com, 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. · qualio.com, 4 Oct 2026
Quality workflows
The platform includes training management, supplier quality management, configurable quality event workflows, reporting and analytics, and design controls. · qualio.com, 4 Oct 2026
Security certifications
Qualio's data processing addendum lists active ISO/IEC 27001, ISO/IEC 27701, ISO 9001, and ISO 42001 certifications. · qualio.com, 4 Oct 2026
Support
The pricing page says its global support team provides weekday chat and email support. · qualio.com, 4 Oct 2026

Where Qualio stands on Freedom251

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