# Qualio

> Cloud-based quality management and compliance platform with AI-powered gap analysis for life sciences and medical device companies

- **Canonical URI:** https://www.vioscale.ai/software/qualio
- **Category:** Quality Management Qms
- **Homepage:** https://www.qualio.com
- **Also known as:** qualio
- **Profile claimed by vendor:** no
- **Last updated:** 2026-08-24T21:16:21.479Z

## Vioscale score

**36.6 / 100**, confidence 61% (medium). Computed 2026-09-01. _(updating — computed under an earlier model version or past its freshness window.)_

Composite of weighted, independently-sourced signals (no user reviews, no vendor payment).

| Signal | Score | Weight | Contribution | Evidence present |
|---|--:|--:|--:|:--:|
| price_level | 0 | 0.052 | 0 | - |
| reliability | 45 | 0.073 | 3.3 | ✓ |
| capabilities | 96 | 0.04877777777777778 | 4.7 | ✓ |
| integrations | 38 | 0.04066666666666666 | 1.5 | ✓ |
| security_posture | 30 | 0.073 | 2.2 | ✓ |
| pricing_transparency | 0 | 0.084 | 0 | ✓ |

## Pricing

_As of 2026-08-24, [verify at source](https://www.qualio.com/pricing). Independently observed._

Subscription

> Annual recurring subscription. Implementation fee applies to all plans. Pricing not transparent; contact for quote.

| Plan | Price | Free | Commitment |
|---|---|:--:|---|
| Foundation | Contact sales | - | annual |
| Growth | Contact sales | - | annual |
| Enterprise | Contact sales | - | annual |

### Foundation (Contact sales)

For teams formalizing quality management and preparing for first regulatory submission

**Included limits:** 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 sales)

For scaling organizations managing compliance across multiple markets, frameworks, and teams

**Included limits:** 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 sales)

For 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)**

## About

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.

_Independently observed._

## Platform & deployment

- **Platforms:** Web
- **Deployment:** 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

## Capabilities

_The capabilities that matter for Quality Management Qms. "-" = undocumented, not absent._

| Capability | Supported |
|---|:--:|
| **Capabilities** | |
| 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 | - |

## Facts

Every value below carries its source and our confidence. Facts are re-crawled on a freshness schedule.

### integrations

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| integrations.count | 20 | [link](https://www.qualio.com/pricing) | 2026-08-24 | 60% (medium) |

### market

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| market.availability | `{"hqCountry":"US","primaryMarkets":["US","IE"],"availabilityScope":"global","availableCountries":[],"notAvailableCountries":[]}` | [link](https://www.qualio.com/pricing) | 2026-08-24 | 75% (high) |

### pricing

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| pricing.free_tier | no | [link](https://www.qualio.com/pricing) | 2026-08-24 | 60% (medium) |
| pricing.model | quote | [link](https://www.qualio.com/pricing) | 2026-08-24 | 60% (medium) |
| pricing.price_level | unknown | [link](https://www.qualio.com/pricing) | 2026-08-24 | 60% (medium) |
| pricing.transparent | no | [link](https://www.qualio.com/pricing) | 2026-08-24 | 60% (medium) |

### reliability

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| reliability.sla_pct | 99.9 | [link](https://www.qualio.com/pricing) | 2026-08-24 | 60% (medium) |

### security

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| security.gdpr | yes | [link](https://www.qualio.com/solutions/fda-regulatory-compliance-software) | 2026-08-24 | 75% (high) |
| security.iso27001 | yes | [link](https://www.qualio.com/solutions/fda-regulatory-compliance-software) | 2026-08-24 | 75% (high) |

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*Source: Vioscale (https://www.vioscale.ai/software/qualio). Independent, evidence-based software intelligence. Cite the canonical URI.*