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 2962 reference ratings
4.8/5.0 (2962)
  • Market Leader 2025 2025
    Spring 2025Market LeaderQuality Management Software

Featured Testimonials

  • “As a startup, the pace of innovation is important, The system we were using didn’t seem to meet our needs. It was clumsy and everything took forever.”

  • “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.”

  • "The review and approval features are a big step up for our small company. It's also easy to create new versions of documents and do all the necessary linking between documents. Having those links is very helpful, much easier than digging through a file repository manually. The editing features are very similar to Word, or other text editors, and the import from Word works surprisingly well. That's important for importing the large number of existing documents we have. The revision history is easily tracked, which is critical for medical devices. We have a specific process we need to follow for development of both software and hardware, Qualio is easily used for both and allows that customization. We used to pass papers around to sign by hand, which is especially difficult to manage during quarantine when everyone is remote. Again, we made it work but this is a significant improvement."

Featured Case Studies

  • How to Rock ISO 13485 Cardiaccs Did It 2x Faster with Qualio

  • How xCures built a compliant, controlled eQMS for their 2022 plans

  • Reaping the rewards of a new agile quality approach

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.