Qualio

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Read 104 Qualio reviews and testimonials from customers, explore 41 case studies and customer success stories, and watch 21 customer videos to see why companies chose Qualio as their Quality Management Software

Qualio is a cloud-based quality management software system designed for life science companies.

Qualio empowers medical device, pharmaceutical, biotech, and contract organizations to get to market faster, boost revenue, and cut risk. Over 500 companies in 80 countries use Qualio to embed and automate GxP, FDA, and ISO compliance. Qualio unites your teams, processes, and data in a single source of truth that supports a culture of quality and makes your business stronger, fitter, and more competitive.

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Customer Rating Review Scorebased on 3086 reference ratings
4.8/5.0 (3086)
  • Market Leader 2025 2025
    Spring 2025Market LeaderQuality Management Software

Featured Testimonials

  • "Qualio is a great tool for documentation. The organized digital lab notebooks, pages, and sections in a document are some of my favorite features. Everything helps to categorically arrange and save information. Organizing and recording data properly is a problem we are solving by using Qualio. Making work instructions etc. It also helps in training new people on the team on a regular basis."

  • "Those quality cultural aspects - accepting having to follow process, establish process, communicate process, evidence the existence of those things - didn't really exist."

  • "Just building a compendium of everything you need to show the notified bodies can be tricky if you're doing it manually. We wanted to start on the right footing."

Featured Case Studies

  • How Ender Diagnostics' quality manager built an in vitro medical device QMS with Qualio

  • Linical Uses Qualio to Streamline CRO Efforts and Help Biotech and Pharma Companies Secure Regulatory Approval

  • Expression Therapeutics optimizes document management with Qualio

Featured Customer Videos

Additional Qualio Information & Resources

Read Qualio Reviews, Testimonials & Customer References from 104 real Qualio customers.

Browse Qualio Case Studies, Customer Success Stories, & Customer References from 41 businesses that use Qualio.

Watch Qualio Customer Videos to learn why 21 businesses chose Qualio.

Explore answers to frequently asked questions about Qualio.