Product Overview
Qualio, a cloud-based eQMS, helps companies in the life sciences sector replace traditional paper-based quality management processes with digital solutions. The platform hosts a wide range of tools for effective supplier management and risk mitigation. It supports robust product development processes from a single source of truth to ensure compliance and audit readiness. Additionally, Qualio provides pre-configured templates for FDA and ISO compliance, and access to quality experts, making it a valuable tool for organizations aiming to meet and exceed quality assurance goals.Pros
- Good size program for the price
- Meets FDA standards
- Good fit for first-time QMS
- Reduces physical paper trail
Cons
- Potentially complex setup
- Limited non-life science use
- Requires regular updates for best performance
Target Market
Organizations in the life sciences sector seeking a comprehensive, easy-to-use quality management system to manage compliance, streamline product development, and mitigate risks effectively. It’s particularly beneficial for organizations requiring adherence to specific regulatory standards like FDA and ISO.About Qualio
Video Overview
Features
Quality platform with:
- Design Controls
- Training Management
- Audit Management
- Document Management
- Risk Management
- Supplier Management
- Events for CAPAs and Nonconformances
Product Overview
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User Reviews of Qualio
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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.
