The #1 CAPA management software for closed-loop quality improvement
Challenge
Your quality teams need established CAPA management solutions 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.
Solution
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 best-in-class CAPA system software
- Build flexible CAPA software workflows 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 living in a single non conformance management software area
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 your CRM, help center and ticketing systems to our CAPA management software to track and manage post-market surveillance and pharmacovigilance activity with ease
Find the root cause and become proactive
- Find the root cause then fix it, with data at your fingertips for continuous quality improvement
- Cross-reference centralized data objects like customers, tickets and equipment, and link events to documents and training records for a joined-up approach
- Avoid bottlenecks with an automated routing and escalation process to expedite issue resolution
CAPA & NCR management resources
Nonconformance management software datasheet
Learn how our CAPA management software arms your business with end-to-end control of your CAPAs, non-conformances and more
Audit readiness
checklist
Will your CAPA and NCR processes make your auditor happy? Plug gaps and prepare for that next audit with our readiness 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.
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.
Trusted by 500+ life sciences companies
Hear from our customers
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"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
"We were able to complete a demanding audit thanks to Qualio. The smart links made navigating between processes seamless and easy to understand."
Thais S.
Head of Quality & Regulatory Affairs, Cergenx
“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