CAPAs & NONCONFORMANCES

Drive continuous improvement by managing any kind of quality event

Our Events module makes 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 cloud-based Events module 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

  • Efficiently create a compliant CAPA workflow process with custom stages for non-conformances, deviations, incidents, near misses and complaints.
  • Automate tasks and reminders to get your teammates involved in quality event processes.
  • Ensure supplier relationships stay intact with an organized process for SCARs.
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Visibility across the entire organization

  • Flexible reporting so you can easily keep management up to date on incident rates, open CAPAs and VoEs and more.
  • Enjoy a single source quality system where everything is connected from design controls to training to audit reports.
  • Update a product's risk management file and DHF easily referencing an associated CAPA.
  • Connect your team’s support systems like Netsuite and Zendesk to Qualio via API, making complaint escalation seamless.
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Easily determine root cause and become proactive

  • Determine root cause with a fully-connected system and full visibility into the entire product lifecycle. 
  • Simply create new documents and forms from CAPAs to ensure glitches don’t repeat. 
  • Avoid bottlenecks with an automated routing and escalation process to expedite issue resolution.
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QUALIO+ SERVICES

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.
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Regulatory content

Pre-configured templates and pre-written documentation for FDA & ISO compliance.

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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!

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“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
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“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
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“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
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“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
Small-Business
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”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
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“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

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Document management

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

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Design controls

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

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Risk management

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

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Training management

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

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Change control

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

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Audit management

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

SEE QUALIO IN ACTION

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