CAPA & Non-Conformance Management Software

CAPA MANAGEMENT

From detection to close-out in one connected system

CAPA and non-conformance management from detection to root cause to corrective action. Every step tracked, every outcome linked to your quality system.

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But corrective and preventive action (CAPA) and nonconformance management processes that run on outdated legacy tools can no longer keep up with the demands of modern life science.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

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.

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.

Compliance management

Get audit-ready in weeks, stay audit-ready forever.

Trusted by 500+ life sciences companies

Hear from our customers

“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

"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."