CAPA and non-conformance management software

Make CAPA and non-conformance management stress-free.
From detection to close-out, get proactive and 100% audit-ready.

Why adopt CAPA software?


Spotting and fixing problems is the key to proactive, improvement-based quality management.

But corrective and preventive action (CAPA) and nonconformance management processes that run on outdated legacy tools can no longer keep up with the demands of modern life science.

You need instant visibility of issues, and of who's doing what and when to put things right.

Qualio's CAPA management software gives your business a centralized, workflow-driven platform for driving continuous improvement in a consistent, fully traceable way - without the headache of admin and upkeep.

The #1 CAPA management software for closed-loop quality improvement



Your quality teams need established and controlled procedures for detecting and stamping out defects and weaknesses.

Your auditors expect consistent CAPA and nonconformance management.

And your siloed, paper-based QMS simply can't give you the visibility and control you need.



Qualio Events operates as both CAPA management software and nonconformance management software, unlocking an efficient, automated pathway for managing all your quality events from root cause to close-out.

Build and apply templates, define steps and tasks, and drive quality improvement that you'll be proud to show your auditor.

Save time with automated workflows and templates

  • Create a compliant CAPA workflow process with designated action pathways for non-conformances, deviations, incidents, near-misses, complaints and more
  • Route tasks, collaborate and comment on events and send automatic reminders to keep your teams aligned
  • Stamp out defects and stop them re-occurring with a consistent, traceable approach

Visibility across your entire organization

  • Access powerful reporting on incident rates, closed CAPAs, outstanding tasks and more
  • Trace a quality event from beginning to end in a single source of truth
  • Connect third-party systems like Salesforce to Qualio Events to consistently manage events such as customer complaints as they arise

Find the root cause and become proactive

  • Determine the root cause and fix it with data at your fingertips and designated action workflows
  • Link events to other system areas like documents and training for a joined-up approach
  • Avoid bottlenecks with an automated routing and escalation process to expedite issue resolution

CAPA & NCR management resources


Quality event management datasheet

Learn how Qualio Events arms your business with end-to-end control of your CAPAs, non-conformances, change controls and more.

Get my datasheet

Audit readiness

Will your CAPA and NCR processes make your auditor happy? Plug gaps and prepare for that next audit with our readiness checklist.

Get my checklist

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


Document management

Make paper, filing cabinets, folders and spreadsheets a thing of the past. 


Supplier management

Control and categorize suppliers and third parties with complete visibility.

Design control management

Supercharge your product development from a single source of truth. 


Training management

Build a competent, confident, compliant, continuously improving workforce. 


Risk management

Detect and mitigate risks and comply with
ISO 14971
and ICH Q9.


Audit management

Make compliance and audit readiness the natural core of your business DNA.


Change control management

Manage change activity easily and effectively with complete traceability. 

Don't just take our word for it!

Hear from our many happy customers

"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"We looked a lot at how Qualio worked, its user interface, and the technology behind it. It was by far the freshest, most logical eQMS system out there."
Dmitry F.
Chief Technology Officer, ViQi
"I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
"Qualio’s become a verb here. When people need things, Qualio is the word that’s used."
Chris R.
QA Associate, AGADA Biosciences
"There are other eQMS providers that are very well-established, but not particularly accessible.

Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind."
Phil C.
Quality Manager, Bond Digital Health
"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of an FTE. 

Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
“The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
"I entered a world with Qualio where quality is no longer a hassle."
Fedora B.
Co-Head of Biopharma Corporate Finance, JMP Securities
“We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.”
Jeffrey B.
CEO, FifthEye
“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
"Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"Qualio is far superior to other
systems I've worked with in the past.
The flexibility has been mind-boggling."
Michael H.
QA Director, TriMed
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"Document control took anywhere from 5 hours to 3 days. Now things get done in hours, even minutes. I can send training out in seconds now. Qualio has made my life 100% better!"
Angela P.
QA Manager, Akadeum Life Sciences
"Qualio helps me sleep better at night.
Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant."
Heather U.
CEO, EvoEndo
"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
"I feel 100% ready in our 510(k) and ISO 13485 preparations.
Qualio let us bring quality in-house in a way that will make us successful."
Hilary B.
VP of Regulatory & Quality, SimBioSys
"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
“We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing
quality to one department, Qualio breaks down that barrier.
Daniel A.
Chief Technology Officer, InVivo Bionics
"When you're using paper, you're not moving forward. You can't.
Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now.
I don't think that'd be possible if we didn't have Qualio."
Ami A.
Director of Ops & Quality Management, NeuFit
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech

Learn why we're the CAPA management software platform of choice