kitio.aiAdded Nov 5, 2026
Qualio
From $25000/yrQuality management system for life sciences with an AI copilot
What is Qualio?
Qualio is an electronic quality management system for pharma, biotech and medical device companies, covering documents, training, events and regulated product development. Its Copilot drafts routine quality work that your team then reviews and approves.
Built-in frameworks map your processes to standards such as ISO 13485, the FDA QMSR, ICH E6(R3) good clinical practice and ISO 42001 for AI management. The product lifecycle module tracks design controls from requirements through release for regulated products.
Qualio AI includes the Copilot, task agents and an MCP connection so your own AI tools can work with Qualio data. It is sold on annual contracts priced by plan and licensed users, and staff who only read documents or complete training are not charged.
Features
- Electronic QMS
- Regulated product lifecycle
- Built-in compliance frameworks
- AI Copilot drafting
- MCP access for your AI
- Tool integrations
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Releases
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Organization
Qualio
Listed by kitio.ai · unverified owner
Pricing
- Pricing model
- Paid
- Paid options from
- $25000/yr
- Billing frequency
- Yearly
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Pros and cons
Pros
- Made for regulated life sciences teams
- Readers and trainees use it free
- Covers both QMS and product development
Cons
- Plans start at $25,000 a year
- Annual contracts only
- Overkill for unregulated companies
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Q&A
What is Qualio?
Qualio is an electronic quality management system for pharma, biotech and medical device companies, covering documents, training, events and regulated product development. Its Copilot drafts routine quality work that your team then reviews and approves.
Which standards does Qualio support?
Frameworks include ISO 13485, the FDA QMSR, ICH E6(R3) and ISO 42001, with more listed on the frameworks page.
Who needs a paid Qualio license?
Only licensed users who author and manage quality work. Everyone else in the company can read documents and complete training at no charge.
How much does Qualio cost?
Qualio is paid, with paid plans from $25000/yr.
Is there a free version of Qualio?
No. Qualio is a paid tool.
What are the main features of Qualio?
Electronic QMS, Regulated product lifecycle, Built-in compliance frameworks, AI Copilot drafting, MCP access for your AI, Tool integrations.
Who makes Qualio?
Qualio is made by Qualio.
What are the best alternatives to Qualio?
Popular alternatives include Dot Compliance, Vanta, Secureframe Questionnaires.