Audit-ready and compliant QMS software for contract research & manufacturing

Drive growth with quality software purpose-built for contract research and manufacturing organizations. Optimize quality, streamline your operations and maximize sponsor satisfaction.

eQMS for CROs and CMOs

90% of our customers report boosted scalability and growth!



Contract research and manufacturing organizations are burdened with paper-based quality processes. These slow down your client projects, impede auditability and dampen sponsor satisfaction.

And when you do try to digitize, expensive and clunky systems with complex validation processes get in your way.



CROs and CMOs build client trust and reputation, cut documentation, collaboration and information transfer time, and increase their revenue with Qualio’s all-in-one eQMS.

Qualio is an affordable, scalable and flexible eQMS that grows with your business and makes meeting your sponsors' quality requirements simple and automatic.

Comply with any regulatory standard

  • Meet key requirements like FDA 21 CFR Part 210/211, ICH E6 (R3) and 
    ISO 14155 with ease and consistency
  • Capture and manage events like 
    non-conformances, deviations and 
    complaints - then generate detailed 
    reports on training, audit trails, 
    change control and more
  • Drive closed-loop quality for all 
    contract projects with end-to-end traceability

Manage quality processes in one place

  • Embed quality and GxP into your organization with an all-in-one QMS platform that scales with you as you add new clients
  • Unify people, processes and third parties
    across your operation in real time
  • Gain complete visibility into your processes and proactively identify risks and opportunities

Focus on sponsor projects, not admin

  • Get up and running fast with simple 
    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

Contract manufacturing software for a stronger operation


CxO quality software datasheet

Learn how international CROs and CMOs use Qualio for unshakeable quality and compliance.

Get my datasheet

Don't just take our word for it!

Hear from our happy CRO and CMO customers

You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately.
That’s a feature I’m greatly enjoying.
Tyler C.
Executive Director of Quality, Linical Americas
"Qualio shows we're taking quality seriously and investing in quality improvement initiatives.
We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers."
Edgar G.
Quality Assurance Specialist, The Dot
"Now that we’re electronic, we can grow to 500 or 1,000 employees.

Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel."
Adolfo R.
Director of Information Systems & Data Compliance, IRISYS
“It was pretty much a unanimous decision to go with Qualio right from the beginning.”
Gene V.
Quality Manager, Cirris
You can get any document you need very quickly and present it within a matter of minutes. Compared to other systems that require long, drawn-out processes that are not necessarily as quick or friendly.”
Tyler C.
Director of Quality, Linical Americas
“Qualio helped us achieve a high level of deployment in a short amount of time. It’s very visual, very easy to understand, and very intuitive.”
Edgar G.
Quality Assurance Specialist, The Dot
“My job got really, really easy. I can’t even change a word anymore with it being documented.” 
Gene V.
Quality Manager, Cirris
“I think Qualio+ has been the most valuable thing. It’s allowed me to deploy an eQMS across an organization in a record amount of time. They were there 100% of the time, offering solutions for the success of our initiative here.”
Edgar G.
Quality Assurance Specialist, The Dot
“The auditor comes in, looks at the documentation, sees how it works and how everything is documented so nicely inside Qualio, and there’s no question, we just move on to the next step.”
Gene V.
Quality Manager, Cirris

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