Seamlessly manage Change Control across your entire business

Qualio’s change control software allows you to manage any change easily and effectively, ensuring compliance and audit readiness.

The #1 solution that solves today's challenges



It can be difficult in a paper-based or segmented quality system to know the downstream impacts of any change. As a result, change control can halt your product development process, and audits of your quality system may result in findings or complications with suppliers.



Qualio streamlines Change Control by providing actionable insight on changes made across quality artifacts - from Documents and Templates to Design Controls. We enable end-to-end traceability and auditability for every change, ensuring your team is compliant and building a safe and effective product.

Get the fundamentals of change control in one place

  • Document, review, and approve changes on documents, templates, Design Controls artifacts — in one system.
  • Manage change control within each document rather than having a change order cover sheet in a paper-based system. 
  • Auditors look for changes driven by a quality event (complaint, CAPA, etc.) show auditors these driving documents quickly and easily.

Full traceability and auditability for every change

  • Whether a change was driven by an event or an expected process improvement, show the what, when, why, and how anything was changed. 
  • Ensure everyone is up-to-date on changes with automated notifications, approval, and training workflows. 
  • Connect your team’s tech stack via API (Jira, TestRails, etc) and run change control on artifacts from those systems directly in Qualio.

Make needed changes easier and faster

  • Your entire quality system is linked together making changes easier to justify, review, document, implement, and train. 
  • Get an export of change documents and change logs throughout your quality system.
  • Make changes scalable as you grow with integrated document control and training management with notifications and alerts.

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 Cochran
Executive Director of Quality, Linical Americas
“Qualio has helped make my life as a Quality Manager very easy. For the documentation side, as soon as an auditor comes in and audits, they can see everything in the audit trail. Nothing is missing, nothing can be changed without it being documented and the auditors think that is so great.”
Gene Vought
Quality, Cirris
“Having everything in one place. That you can connect or link documents to other documents and keep the traceability of any changes made or decisions made.”
Dragan Velickovski
Software Engineer, Axiom
“Qualio has made it so much easier to review and edit documents prior to document release. This has improved the quality of our documentation and reduced the amount of time spent on getting documents through our release process.”
User in Medical Devices
”I like the very flexible approach that Qualio offers to deal with document type of information. A document can be basically everything from an SOP, over an HR file to an Equipment log. This is very powerful in particular in combination with the tagging feature.“
Christian S
Consultant CMC + QA
“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.”
Sravya D
Medical Fulfillment Specialist

See other features that make Qualio
the #1 top rated cloud QMS


Document management

With Qualio’s secure and cloud-based system, paper files, folders, and spreadsheets become a thing of the past.


Design controls

Qualio’s Design Control accelerates medical device product development by uniting your systems and data in one place.


Risk management

Prevent potential risks early and mitigate risk easily with easy risk management that complies with ISO 13485 and ISO 14971.


Training management

Create assessments, assign, report, and track training activity across your company within one platform.


Audit management

Seamlessly generate reports on activity across your system and your users and set periodic review cadences.


CAPAs & Nonconformances

With Qualio Events, manage pre-defined actions and responses and track in accordance with regulatory requirements.


Learn why we have been ranked the quality management platform of choice