Qualio
Cloud-based quality management and compliance platform with AI-powered gap analysis for life sciences and medical device companies
- Also known as
- qualio
Available worldwide · Popular in: US, IE
What is Qualio?
A cloud-hosted quality management system (eQMS) combining document control, training management, design controls, and compliance frameworks. It helps life sciences and medical device companies automate regulatory compliance with FDA, ISO, and international standards using AI-powered gap analysis and continuous monitoring.
Qualio pricing
Plans, per-tier features and add-ons, dated and linked to live pricing. Pricing changes often; always verify at source before you rely on it.
Annual recurring subscription. Implementation fee applies to all plans. Pricing not transparent; contact for quote.
Foundation
Contact salesFor teams formalizing quality management and preparing for first regulatory submission
- compliance_frameworks
- 3 (FDA, MDR, ISO, GxP)
- integrations_included
- 2 product development tools + 3 core (SSO, OneDrive, Jira)
- Document Control with version control and approval workflows
- Training Management with compliance automation
- Supplier Quality Management
- Quality Events management with 5 templates
- Compliance Dashboard with real-time visibility
- Team Collaboration on Audit Tasks
- AI-powered gap analysis and compliance monitoring
- Documentation Mapping to regulatory controls
- Automated Evidence Collection
- Design Controls with risk matrix and FMEA
- CAPA & NCR management with automated workflows
- Unlimited basic users
- Core integrations: SSO, OneDrive, Jira at no additional cost
Growth
Contact salesFor scaling organizations managing compliance across multiple markets, frameworks, and teams
- integrations
- Full Integration Catalog
- compliance_frameworks
- 5 (expandable with add-ons)
- Everything in Foundation
- Full Integration Catalog including Salesforce, Zendesk, HubSpot, and additional CRM/support tools
- Extended compliance framework support
- Ability to build or adapt compliance frameworks without external consultants
- Multi-market expansion support
Enterprise
Contact salesFor mature quality operations with enterprise-grade complexity, multi-site requirements, and custom configuration
- Custom pricing and implementation
- Dedicated success and support team
- Multi-site and multi-entity management
- Custom configuration and workflows
Add-ons
- Integration Hub
- Additional Compliance Frameworks
- Qualio Plus Content (templates, SOPs, training materials)
What Qualio does
The capabilities that matter for quality management qms, normalised so it lines up with every alternative. “-” means we haven't confirmed it, not that it's missing.
- Deployment model
- Cloud eqms
- Fda 21 cfr part 11 electronic signatures
- ✓
- ISO 9001 13485 preset templates
- ✓
- Capa corrective and preventive action routing
- ✓
- Document control and sop versioning lockdown
- ✓
- Non conformance materials ncmr tracking
- ✓
- Supplier quality management and audit portals
- ✓
- Integrated risk matrix fmea
- ✓
- Employee training matrix and LMS sync
- ✓
- Automated software validation iq oq pq
- -
- SOC2 type ii
- -
- ISO 27001
- ✓
- Pricing model
- -
Platform & deployment
Independently observed- Web
- Cloud / SaaS
Integrations (18)
Independently observed- SSO
- OneDrive
- Jira
- Azure AD
- Azure DevOps
- GitHub
- GitLab
- Xray
- TestRail
- Zephyr Scale
- Linear
- Asana
- Salesforce
- HubSpot
- ComplianceWire
- Intercom
- Zendesk
- Microsoft Dynamics
Qualio FAQ
Common questions about Qualio, answered from independent, dated evidence.
What is Qualio?
A cloud-hosted quality management system (eQMS) combining document control, training management, design controls, and compliance frameworks. It helps life sciences and medical device companies automate regulatory compliance with FDA, ISO, and international standards using AI-powered gap analysis and continuous monitoring. It is indexed under Quality Management Qms.
Source: https://www.qualio.com/pricing
How much does Qualio cost?
Qualio does not publish its prices. Pricing is quoted on request, across 3 plans (Foundation, Growth and Enterprise), so the figure depends on your seat count and requirements. We record this as a pricing-transparency signal rather than guessing a number. Pricing changes often, so verify at source before relying on it.
Source: https://www.qualio.com/pricing
What platforms does Qualio support?
We have confirmed browser-based access to Qualio. That is the extent of what we could verify from public sources, so it may well offer desktop or mobile clients we have not indexed.
Source: https://www.qualio.com/pricing
Can Qualio be self-hosted?
We have only confirmed a cloud / SaaS deployment for Qualio, so it appears to be vendor-hosted. If a self-hosted option exists we have not found it documented publicly.
Source: https://www.qualio.com/pricing
What does Qualio integrate with?
We have confirmed 18 integrations for Qualio, including SSO, OneDrive, Jira, Azure AD, Azure DevOps, GitHub, GitLab and Xray, plus 10 more. This is what we could verify from public sources, so the vendor may support others we have not indexed.
Source: https://www.qualio.com/pricing
What security certifications does Qualio have?
We have independently confirmed ISO 27001 and GDPR for Qualio. Certifications we do not list are ones we have not been able to verify from public sources, which is not the same as Qualio not holding them. Always confirm compliance directly before you rely on it.
Source: https://www.qualio.com/solutions/fda-regulatory-compliance-software
Where is Qualio available?
Qualio is available worldwide. Its primary markets are the United States and Ireland. The vendor is headquartered in the United States.
Source: https://www.qualio.com/pricing
Qualio alternatives
Other quality management qms we track, ranked by the same independent score.
- SimplerQMSlow · 45%
- Veeva Vault QualityA cloud-based quality management platform for regulated manufacturerslow · 14%
- ETQ Reliancelow · 2%
- ScilifeDigital quality management platform that streamlines compliance processes for life sciences organizationslow · 23%
- Arena QMSA cloud platform that unifies product information, people, and processes to eliminate organizational silos and accelerate product developmentlow · 36%
Compare Qualio
Side by side against other quality management qms, attribute by attribute, with a source on every value.
The vioscaleAI score: one lens on the evidence
Not user reviews and not a paid placement: a confidence-weighted blend of the independent signals below (adoption, activity, security posture, and more), which you can sort and re-weight yourself. Vendors can correct their listing but can never move their rank, and stars are weighted low as a vanity metric. It is one way to read the evidence for Qualio, not the verdict.
| Signal | Score | Weight | Contribution | Evidence |
|---|---|---|---|---|
| Capabilities | 96 | 0.04 | 4.1 | ✓ |
| Reliability | 45 | 0.06 | 2.8 | ✓ |
| Integrations | 38 | 0.05 | 1.9 | ✓ |
| Security posture | 30 | 0.04 | 1.3 | ✓ |
| Price level | 0 | 0.10 | 0.0 | - |
| Pricing transparency | 0 | 0.09 | 0.0 | ✓ |
Computed . Re-weight it by intent, or see the full method.
All data & sourcesshow ↓
Every value we hold, with its source, retrieval date, and confidence. This is the evidence behind the score: don't trust it, verify it.
Content
| Attribute | Value | Evidence |
|---|---|---|
| Faq | 7 items | mediumsource · 2026-09-10 · 64% |
Features
| Attribute | Value | Evidence |
|---|---|---|
| Capabilities | Iso 27001: Yes · Deployment model: cloud_eqms · Integrated risk matrix fmea: Yes · Iso 9001 13485 preset templates: Yes · Employee training matrix and lms sync: Yes · Non conformance materials ncmr tracking: Yes | mediumsource · 2026-08-24 · 60% |
Integrations
| Attribute | Value | Evidence |
|---|---|---|
| Count | 20 | mediumsource · 2026-08-24 · 60% |
Market
| Attribute | Value | Evidence |
|---|---|---|
| Availability | HqCountry: US · PrimaryMarkets: … · AvailabilityScope: global · AvailableCountries: … · NotAvailableCountries: … | highsource · 2026-08-24 · 75% |
Pricing
Reliability
| Attribute | Value | Evidence |
|---|---|---|
| Sla pct | 99.9 | mediumsource · 2026-08-24 · 60% |
Security
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