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 alternatives
Other quality management qms we track, ranked by the same independent score.
- SimplerQMSlow · 5%
- Veeva Vault Qualitylow · 14%
- ScilifeQuality management software that simplifies compliance and audit readiness for life sciences organizationslow · 25%
- ETQ Reliancelow · 6%
- Arena QMSCloud platform that unifies product design, quality management, and manufacturing information for faster product developmentlow · 41%
Compare Qualio
Side by side against other quality management qms, attribute by attribute, with a source on every value.
The Vioscale 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 | 0.05 | 4.7 | ✓ |
| Reliability | 45 | 0.07 | 3.3 | ✓ |
| Security posture | 30 | 0.07 | 2.2 | ✓ |
| Integrations | 38 | 0.04 | 1.5 | ✓ |
| Price level | 0 | 0.05 | 0.0 | - |
| Pricing transparency | 0 | 0.08 | 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.
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% |