Plans and pricing
Quality and compliance,
built in from day one
One platform for quality management, regulatory readiness, and AI-powered gap analysis. Choose the plan that matches where you are today.
Foundation
For teams formalizing quality management for the first time and preparing for their first regulatory submission.
Edit Users
5 included
Basic Users
Unlimited
Best suited for companies
- Preparing for a first FDA or notified body audit and need to find documentation gaps before regulators do
- Managing compliance to 1-3 standards with a lean team and no dedicated regulatory affairs function
- Moving off spreadsheets and want existing documents mapped to regulatory controls from day one
Most popular
Growth
For scaling organizations managing compliance across multiple markets, frameworks, and teams.
Edit Users
10 included
Basic Users
Unlimited
Best suited for companies
- Managing to many standards across multiple markets where manual processes have become a bottleneck
- Assembling audit evidence by hand every time an inspection is approaching
- Expanding into new markets and need to build or adapt compliance frameworks without external consultants
Scale
For mature quality operations with enterprise-grade complexity, multi-site requirements, and custom configuration needs.
Custom pricing. Custom implementation.
Dedicated success and support.
Dedicated success and support.
What is included
Foundation
Growth
Quality Operations
Document Control
Build, distribute, and store quality documents with version control and approval workflows
✓
✓
Training Management
Standardize and automate training compliance across your organization
✓
✓
Supplier Quality Management
Centralize supplier oversight to reduce supply chain risk
✓
✓
Design Controls
Manage product lifecycles from ideation to final delivery
✓
✓
Reporting and Analytics
Guide your quality system with detailed dashboards and analytics
✓
✓
Quality Events
Configure and run action workflows for quality events
5 templates
Unlimited
Resource Library
Import and reference centralized standard resources across Qualio
Product & Root Cause
Unlimited
Qualio CoPilot
AI-powered assistance for core quality workflows including document drafting and review
✓
✓
Audit and Regulatory Readiness
Compliance Frameworks Included
FDA 21 CFR Part 11, ISO 13485, EU MDR, ICH Q10, GxP, FDA 21 CFR Part 820, and more
3
5
AI-Powered Gap Analysis
Automatically identify where your documentation falls short against regulatory controls
✓
✓
Documentation Mapping to Controls
Map your existing documents to regulatory requirements from day one
✓
✓
Compliance Dashboard
Real-time visibility into your compliance posture across all active frameworks
✓
✓
Team Collaboration on Audit Tasks
Assign, track, and complete audit preparation tasks across your quality team
✓
✓
Additional Regulatory Frameworks
Expand beyond included frameworks as your regulatory footprint grows
Additional fee
Additional fee
Custom Framework Builder
Build or adapt compliance frameworks without external consultants
—
✓
AI Remediation Guidance
AI-generated recommendations to resolve identified compliance gaps
—
✓
Automated Evidence Collection
Automatically gather and organize audit evidence so nothing is assembled by hand
—
✓
Continuous Regulatory Monitoring
Stay audit-ready year-round, not just ahead of scheduled inspections
—
✓
Platform and Integrations
Core Integrations
SSO, OneDrive, Jira — included at no additional cost
✓
✓
Integration Hub
Extend connectivity across your tech stack — available as an add-on
2 integrations
Dev catalog
Dev catalog
3 integrations
Full catalog
Full catalog
Developer API
Build custom integrations and automate workflows programmatically
—
✓
Additional Edit Users
Additional fee
Additional fee
Multiple Instances
Manage multiple sites or entities with easy navigation between instances
—
Additional fee
Integrations
All plans include core integrations at no additional cost. The Integration Hub add-on extends connectivity across your full tech stack. Foundation customers access the development tools catalog. Growth customers access the full catalog.
Foundation — Core & Dev Tools Catalog
Included: SSO, OneDrive, Jira. Integration Hub add-on unlocks dev tools.
SSO
OneDrive / SharePoint
Jira
GitHub
Azure DevOps
Productboard
Intercom
Growth — Full Integration Catalog
Everything in Foundation, plus the complete catalog including CRM and support tools.
SSO
OneDrive / SharePoint
Jira
Salesforce
HubSpot
Intercom
GitHub
Azure DevOps
Productboard
Zendesk
Microsoft Dynamics
Testrail
ZephyrScale
Xray Cloud
GitLab
Linear
Available add-ons
Extend your plan with additional capabilities as your needs grow.
Frequently asked questions
How does pricing work?
Qualio works with life science companies of all shapes and sizes, and our pricing is built to match their specific operational needs. After an initial conversation to understand your business and requirements, we will provide a tailored quote.
Is Qualio priced as a one-off or recurring cost?
Qualio is a modern, cloud-based software provider that offers an annual recurring subscription model. Your subscription includes all platform updates, cloud storage, and support — with no hidden fees.
Can we add more users later?
Yes. Additional edit users can be added at any time. Basic users are unlimited in both plans at no additional cost.
How long does implementation take?
With the right preparation from your team, most customers are live within 30 to 60 days. Our onboarding team is made up of industry experts who guide you through every step.
Can Qualio support multiple instances?
Yes. Growth customers can add additional instances to manage multiple sites or entities, with easy navigation between them. Talk to us for details.
Is data storage included?
All cloud storage is included in your subscription. Qualio is ISO 27001 certified, so your quality data is protected to the highest standards.
Which regulatory frameworks are supported?
Qualio supports FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, EU MDR, ICH Q10, GxP, and more. Foundation includes 3 frameworks. Growth includes 5. Additional frameworks are available as an add-on.
What does customer support look like?
Our global support team provides weekday chat and email support. 86% of customers self-serve through our Knowledge Base, but we are always available when you need us.
Ready to see Qualio in action?
Talk to our team and get a plan built around your regulatory requirements and growth stage.