Stand out with a seamless, audit-tested eQMS

Gain a competitive edge with a quality management solution purpose-built for contract research and manufacturing organizations. Qualio’s flexible platform streamlines your operations, so you deliver results more efficiently.

eQMS for CROs and CMOs



Many contract research and manufacturing organizations are burdened with paper-based processes that slow down services. Costly solutions require custom engineering and constant revalidation.



CROs and CMOs can save time and money with Qualio’s all-in-one quality management system. Build off of flexible workflows and templates to scale your QMS alongside your business.

Manage quality processes in one place

  • Enable quality with an all-in-one platform that scales as you add new clients.
  • Unite people, suppliers, and change control across your entire business in real-time.
  • Gain comprehensive visibility into your processes so you can identify gaps proactively.

Focus on your projects, not paper trails

  • Get up and running fast with simplified onboarding for everyone on your team.
  • Execute guided workflows for drafting, reviewing, approving and retiring documents.
  • Use templates and workflows that make CAPA management easy.

Support for compliance with all regulatory standards

  • Generate detailed reporting on training, audit trails, change control and more.
  • Capture Events like non-conformances, deviations and customer complaints.
  • Enable closed-loop quality for all your projects with end-to-end traceability.

Have quality and regulatory
experts on your side

Add Qualio+ to any plan and receive expert quality assurance
support to help growing companies get to market faster.

Regulatory content

Pre-configured templates and pre-written documentation for FDA & ISO compliance.


Quality assurance experts

Access to our team of quality experts to ensure you meet and exceed your QA goals.

Don't just take our word for it!

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.
Tyler C
Executive Dir. of Quality, Linical Americas
The Validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support chat function. It is easy to get in touch with the Qualio team with questions or concerns and the team responds quickly.
Soni M
Director QA/RA, NovoSource
My favorite thing is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding.
Deb Glancy
Director of Quality
“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.”
David Hughes
CEO, Surfatek
“Qualio has been super helpful to us feeling like we have all the pieces in place for quality management system… to an FDA standard.”
Jen Baird
CEO, Fiftheye
“We evaluated all players on the market ... and came up with Qualio as the best balance of price, capability, and quality of support. Really like the change event management, API flexibility, training tracking, and customer success support.”
Jeffrey B
CFO, Fiftheye

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