Pass every audit every time with the #1 audit management software

Don’t leave your audit preparation to chance. Easily comply with the wide range of quality standards with Qualio’s cloud-based and fully integrated quality management system.

The #1 solution that solves today's challenges



Audits can be large and resource-heavy activities due to the scope of examining the entire quality system periodically. Quality managers can feel tremendous stress if there are gaps in their data and quality processes. Being unprepared for an audit, whether internal or external, can lead to fines, penalties, or worse product recalls.



Qualio’s cloud-based quality management system gives your team the tools to be 100% audit-ready at any time. Easily provide all artifacts needed for an audit, prove compliance, demonstrate continuous improvement, and report on the status of any findings. With Qualio, audits are faster and no longer stressful.

Be 100% compliant and inspection ready

  • Show continuous improvement from past audits with organized documents, procedures, and automated internal audit schedules and tasks. 
  • Identify gaps and predict quality performance with a connected quality ecosystem. 
  • Have confidence knowing your system is fully compliant with ISO 9001, ISO 13485, ISO 14971, FDA CFR Part 11, CFR 820, CFR 210/211, and EU MDR to name a few.

Save time with automated document and data processes

  • Avoid the challenges of paper-based audits with a cloud-based QMS complete with controlled access—making even remote audits possible. 
  • Find all audit artifacts with one click using document templates and tagging.
  • Build workflows to assign tasks and automate reminders all from one place.

Make audit-readiness your competitive advantage

  • Turn fines, penalties, and product recalls into a thing of the past by connecting your data and teams into one centralized quality system.
  • Easily assign audit tasks, manage due dates, and track any audit findings to completion. 
  • Enjoy end-to-end traceability for all CAPAs, nonconformances, and other quality events to show auditors continuous improvement.

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.


Change control

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


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