Quality Management Software

Go from disconnected quality systems, data, and sources to a
single, automated, and efficient platform.

Qualio customers know that quality-driven means happy customers, high-quality products, engaged employees and faster revenue growth.

Let us show you what quality-driven looks like.


Achieve end-to-end traceability

Track every change and action from beginning to end with fully integrated, closed-loop quality processes. Keep all key stakeholders informed with Qualio’s powerful reporting capabilities.

  • Smart links between records
  • Closed-loop quality processes
  • Powerful reports


Automate quality processes

Automate all quality processes with simple, guided workflows. Monitor activities and close-out processes like change control and CAPA on time, every time.

  • Step-by-step guided workflows
  • Automated reminders
  • Linked quality processes

Follow ISO/FDA best practices

Qualio is the first cloud QMS designed to incorporate the latest FDA, ISO, medical device, and therapeutics best practices. Focus on growing your business, while Qualio takes care of compliance and quality.

  • FDA 21 CFR Part 820
  • 21 CFR Part 11 Compliant
  • ISO 13485:2016 & ISO 14971

Streamline team communication

Improve collaboration and avoid unnecessary meetings, emails, and communication across apps.

  • Automated notifications and reminders
  • In-line comments
  • Collaborate globally regardless of location
Quality Score

Where do you rank on Quality?

Take a short self-assessment to find out how your organization ranks against quality leaders.


Control and Access Documents

Effortlessly create, review, approve and control documents and records. With Qualio’s secure, cloud-based system files, folders, and spreadsheets become a thing of the past.

Qualio’s template engine and simple web-editor make creating content a breeze, and guided workflows walk you through each step of document drafting, review, and approval.

Incorporates FDA CFR Part 11 compliant digital signatures.


Assign and Capture Training

Integrated, role-specific training supports in-line assignments and tracking of all training activity within the quality platform.

Automated notifications and reporting provide full visibility into training gaps so they can be addressed to maintain quality standards and compliance.

Training assessments make it possible to go beyond "read and understand" training to capture competency.


Identify and Resolve Issues

Quickly capture quality events like non-conformances, deviations, customer complaints and much more. Track progress from creation, investigation, and root cause analysis, to CAPA, validation of successful outcomes and closure.

Assign CAPA-related tasks to your team and track progress through to completion.

See quality trends in real time and take proactive resolution steps.

Capture customer feedback and complaints and link to CAPA and other quality follow-up activities.


Streamline Product Development

Reduce time-to-market by integrating quality and product development processes.

Product development is at the heart of every successful medical device and therapeutics company. Bring devices to market quickly with design control and risk management features that integrate with your pre-production and post-production quality activities.

Capture drug development outputs and collate them together for seamless review and submission at each key step along the regulatory approval pathway.


Pass Audits and Drive growth

Qualio provides a single place to manage audits, suppliers, change management and understand what's happening across your entire business in real time. You can’t do this with paper, hybrid or legacy systems which silo data from different systems.

Qualio is closed-loop quality like you’ve never seen it before.

Make decisions that drive your business forward, confident that you have all the information you need at your fingertips, and empower teams across your business to collaborate.

Trusted by 100's of Customers

Powered by Quality Best Practices

Some companies spend months and tens of thousands of dollars building custom solutions that ultimately underdeliver. We’ve painstakingly built Qualio to follow all relevant ISO and FDA best practices.

Focus on growing your business while Qualio focuses on quality.

Request a Demo