CAPAs & NONCONFORMANCES

Drive continuous improvement by managing any kind of quality event

Make CAPA and non-conformance management stress-free.
From detection to verification of effectiveness, become proactive and 100% audit-ready.

The #1 solution for closed-loop quality improvement

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Challenge

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

Your auditors expect consistent CAPA and NCR management.

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

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Solution

Qualio’s Events unlocks an efficient, automated pathway for managing all quality events from root cause to verification of effectiveness.

Build and apply templates, define action stages, assign tasks and drive a continuous quality improvement system you can 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
  • Automate task routing and reminders to align your teammates 
  • Stamp out defects and stop them re-occurring with a consistent, traceable approach
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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
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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
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CAPA & NCR management resources

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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
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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.

Get my checklist

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

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Document management

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

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Supplier management

Control and categorize suppliers and third parties with complete visibility.
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Design control management

Supercharge your product development from a single source of truth. 

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Training management

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

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Risk management

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

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Audit management

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

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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

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"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
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"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
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“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
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"I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by January. And we had our ISO 13485 certification by July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
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"We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.

The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it"."
Stephana P.
VP of Quality, Alphazyme
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"There are other eQMS providers that are very well-established, but not particularly accessible to organizations that don't have the fundamental basics in place.

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
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"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
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"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one 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
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“The cost of our Qualio licences is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
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"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
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"Set-up is easy and very user-friendly.  Qualio gets rid of the paperwork. Simple to use, affordable."
Rachel A.
Medical Outreach Specialist, eHealth Technologies
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“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
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“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
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"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
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"Any intelligent person would look at Qualio and say, "This is exactly what a cloud-based system should do". But when you actually see it in action, you still think it's pretty cool."
Andrew L.
CEO, ArcScan
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"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
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"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us reduce our workload and our paper trail."
Paul M.
CEO, Arann Healthcare
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"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."
Chris S.
Quality Manager, CureMetrix
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"The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support and chat function."
Soni M.
QA/RA Director, NovoSource
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"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
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"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
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"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
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"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
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"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
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Qualio enabled us to seamlessly work through our ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.
David H.
CEO, Surfatek
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Initially, we didn't have anyone on the quality side.

The support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch.

It was so streamlined, it was so efficient, they were super helpful and communicative.

That's exactly what we needed - and that's why we went with Qualio.
Heather U.
CEO, EvoEndo
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"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
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