An eQMS tailored for the life-sciences industry

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.


  • Good size program for the price
  • Meets FDA standards
  • Good fit for first-time QMS
  • Reduces physical paper trail


  • 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


Quality platform with:

  • Design Controls
  • Training Management
  • Audit Management
  • Document Management
  • Risk Management
  • Supplier Management
  • Events for CAPAs and Nonconformances
Starting Price
Price Range Learn More
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Pricing Details
Platform price, then $3000 per user model

Product Overview

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User Reviews of Qualio

Submitted on May 31st, 2023 by Anonymous

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.

The Good…

Good sized program for the price

Had expereince with our indsutry

The Bad…


Submitted on March 25th, 2022 by Jen Baird

Qualio has been super helpful to us feeling like we have all the pieces in place for quality management system… to an FDA standard.

Submitted on March 25th, 2022 by Paul Maguire

I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail.

Submitted on March 25th, 2022 by David Hughes

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.

Submitted on March 25th, 2022 by SoniM

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.

Submitted on March 25th, 2022 by Dr. Heather Underwood

It’s been a pleasure to work with Qualio.

Submitted on March 25th, 2022 by Sravya D

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.

Submitted on March 25th, 2022 by Tyler Cochran

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.

Submitted on March 25th, 2022 by Nicole H.

I love Qualio… The most user-friendly system that I’ve ever used in my whole career.

Submitted on March 25th, 2022 by Marija K.

Qualio has different modules all in one. No need to have different QMS software.

Submitted on March 24th, 2022 by Sam Dribin

Qualio has helped us tremendously with the QMS and getting started.