Qualio is an eQMS tailored for the life-sciences industry. With a ready-to-use, flexible quality management system that unites teams, processes and data in one place - Qualio helps organizations get to market quickly and scale successfully.
Trusted by life science and healthcare organizations around the globe, Qualio is the trusted quality platform for:
- Medical device and SAMD/diagnostic companies
- Biotech/therapeutic companies
- Contractors (design, development, manufacturing, lab, research) for the above industries
- Pharmaceuticals
Qualio software can scale with your company and is applicable for small, medium, and enterprise organizations.
Video Overview
Features
Quality platform with:
- Design Controls: Supercharge your product development from a single source of truth.
- Training Management: Build a competent, confident, compliant, continuously improving workforce.
- Audit Management: Make compliance and audit readiness the natural core of your business DNA.
- Document Management: Make paper, filing cabinets, folders and spreadsheets a thing of the past.
- Risk Management: Master your risk environment, detect and mitigate risks and comply with ISO 14971 and ICH Q9.
- Supplier Management
- Events for CAPAs and Nonconformances
Change Control capabilities, native integrations and additional Qualio+ services are available to ensure you get support from quality experts.
Pricing
Qualio is available as a subscription-based solution. The platform is $12,000 to start and $3,000 per user. The platform subscription includes all software in the package and up to 10 users. Any additional users can be added for a low annual fee. There is no free trial available.
Integrations
Qualio integrates with your most important apps, so you can spend less time on manual tasks and more building a single source of truth.
- Asana
- Azure DevOps
- TestRail
- Okta
- Jira
- Azure/Office365
- Qualio’s Public API
- Salesforce
- Google Suite
Product Overview
Related Products
User Reviews of Qualio
Write a Review
As a dental device manufacturer, we were looking for a Quality Management System that could move us out of pen & paper into a streamlined system. We ended up finding the Qualio QMS program.
They were able to help us become regulated as a Class 2 dental device! So, ultimately we found that Qualio was able to meet our needs and their pricing fit well.
Good sized program for the price
Had expereince with our indsutry
None
Qualio has been super helpful to us feeling like we have all the pieces in place for quality management system… to an FDA standard.
I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail.
Qualio enabled us to seamlessly work through the ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.
The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support chat function-it’s easy to get in touch with the Qualio team with questions or concerns and the team responds quickly.
It’s been a pleasure to work with Qualio.
The best thing I like about Qualio is how simple the documents are prepared for easy understanding by anyone who has no knowledge on what they’re reading, be it a policy or a basic learning document.
You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately. That’s one feature I’m greatly enjoying.
I love Qualio… The most user-friendly system that I’ve ever used in my whole career.
Qualio has different modules all in one. No need to have different QMS software.
Qualio has helped us tremendously with the QMS and getting started.
