Qualio
by Qualio · Healthcare & Life Sciences
AI-powered eQMS for life sciences: document control, CAPA, training, audits and compliance.
Updated August 2026 · By the ERP Research Editorial Team · Independent and vendor-neutral.
- Deployment
- Cloud
- Company size
- SMB, Mid-market
- Pricing
- Quote-based (annual subscription)
- Founded
- 2012
- Headquarters
- San Francisco, California, United States
Overview
Qualio is a cloud-based electronic quality management system (eQMS) built for life sciences companies -- medical device, pharmaceutical, biotech, software-as-a-medical-device (SaMD), CRO and cosmetics organizations -- to manage the quality processes required for FDA and ISO compliance. Founded in 2012 and headquartered in San Francisco, Qualio reports serving 700+ customers across 80+ countries.
The platform covers document control, design controls, risk management, training management, change control, audit management, CAPA, non-conformance tracking and supplier management from a single system, with analytics dashboards for documents, training, events and suppliers. Qualio markets a "Compliance Intelligence" capability that uses AI to flag compliance gaps against more than two dozen regulatory frameworks, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, MDSAP and EU CE/UKCA marking requirements.
Qualio's documented integrations focus on business tools -- Salesforce, Google Workspace, Microsoft 365, Jira, GitHub, GitLab and Zendesk among them -- rather than ERP systems specifically, and it offers a public API for custom connections. It is sold on an annual subscription across Foundation, Growth and Scale plans, plus an implementation fee; no list prices are published.
Screenshots & demo
Demo video from the vendor's YouTube channel. Screenshots sourced from Qualio.
Features & capabilities
Document Control
Controlled documents with version history and e-signatures.
- Version control and approval workflows
- Controlled document templates
- Electronic signatures
- Document change history
- Role-based access
- Automatic revision tracking
Quality Events (CAPA & Non-Conformance)
Corrective action and non-conformance handling.
- CAPA workflow management
- Non-conformance tracking
- Root cause analysis
- Effectiveness checks
- Audit trails
Training Management
Training tied to controlled document changes.
- Training plan assignment linked to document changes
- Training records and compliance tracking
- Automated training reminders
Audit & Supplier Management
Internal/external audits and supplier oversight.
- Internal and external audit planning and execution
- Supplier qualification and oversight tracking
- Supplier scorecards
Compliance Intelligence (AI)
AI-driven gap analysis across regulatory frameworks.
- AI-driven gap analysis across 28+ regulatory frameworks
- Automated compliance monitoring
- Audit-readiness reporting
- Analytics dashboards for documents, training, events and suppliers
Common use cases
- Managing document control and version approval ahead of an ISO 13485 audit
- Tracking CAPAs and non-conformances end-to-end with root-cause analysis and effectiveness checks
- Running supplier qualification and ongoing supplier quality oversight
- Assigning and tracking employee training tied to controlled document updates
- Using AI-driven Compliance Intelligence to identify gaps against ISO, FDA and EU regulatory frameworks before an audit
- Consolidating quality records for a CRO or SaMD company operating across multiple regulatory jurisdictions
- Preparing for FDA 510(k) submissions or ISO 13485 certification with a single quality system of record
Strengths & considerations
Strengths
- Compliance Intelligence AI feature maps quality records against 28+ regulatory frameworks to surface gaps automatically
- Purpose-built for life sciences (medical device, pharma, biotech, SaMD, cosmetics) rather than a general-purpose QMS
- Qualio itself is ISO 9001 and ISO 27001 certified, not just its software's compliance-tracking features
- Serves 700+ customers across 80+ countries with a G2 rating of 4.7/5 (667 reviews)
Pricing
Three tiers -- Foundation, Growth, Scale -- priced by number of editing users, compliance frameworks and integrations included. No list prices published; implementation fee applies to all plans. Get an independent shortlist with pricing guidance below.
Technical & security
- Hosting
- SaaS (multi-tenant)
- Compliance
- ISO 13485, ISO 9001, 21 CFR Part 11, MDSAP, ISO 27001
About the vendor
- Founded
- 2012
- Headquarters
- San Francisco, California, United States
- Employees
- ~120
- Ownership
- Private (venture-backed, Series B)
Alternatives to Qualio in Healthcare & Life Sciences
Qualio — frequently asked questions
What regulatory frameworks does Qualio support?
Qualio's Compliance Intelligence maps quality records against more than 28 regulatory frameworks, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, MDSAP and EU CE/UKCA marking requirements.
What industries use Qualio?
Qualio is built for life sciences companies -- medical device, pharmaceutical, biotech, SaMD, CRO and cosmetics organizations -- with 700+ customers across 80+ countries.
Does Qualio integrate with ERP systems like NetSuite or QuickBooks?
Qualio's documented integrations focus on business tools such as Salesforce, Google Workspace, Microsoft 365, Jira, GitHub and Zendesk rather than ERP systems; ERP connections would need to go through Qualio's public API.
How is Qualio priced?
Qualio sells three annual subscription tiers -- Foundation, Growth and Scale -- priced by number of editing users, compliance frameworks and integrations included, plus an implementation fee. It does not publish list prices.
Is Qualio itself certified to any standards?
Yes, Qualio holds ISO 9001 and ISO 27001 certification as a company.
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