Quality Management Software

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

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We believe that being quality-driven is key to success. Quality-driven means happy customers, high-quality products, engaged employees and 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 closed-loop quality processes that are linked to each other. Never miss anything with powerful reports.

  • Smart links
  • Closed-loop quality
  • Powerful reports


Automate quality processes

Automate all your quality processes with simple, guided workflows. Understand where everything is at all times and close-out activities 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 with the latest FDA and ISO best practices, specifically for medical device and therapeutics companies. Focus on growing you business while Qualio takes care of compliance.

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

Streamline team communication

Communicate where your team works. Avoid unnecessary meetings, emails, and communication across apps.

  • Automated notifications & reminders
  • In-line comments
  • Work together from anywhere
Quality Score

Where do you rank on Quality?

Take a short self-assessment to find out where your organization ranks on quality against best practices.


Control & Access Documents

Effortlessly create, review, approve and control documents and records. Leave files, folders, and spreadsheets behind so you can collaborate seamlessly with your team.

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

Powered by real-time review and approval of documents and records using FDA CFR Part 11 compliant digital signatures.

Assign & Capture Training

Deliver the right training, to the right people, at the right time. Training is fully integrated with new document revisions and employee onboarding so you can deliver the right training, to the right person,

Automated training notifications and reporting provide full visibility into gaps so they can be closed out.

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

Identify & 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 closure.

See quality issue trends in real time and take pro-active steps to resolve them.

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


Streamline Product Development

Get to market quickly through integrating quality and product development.

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 tie together with your pre-production and post-production quality activities.

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


Pass Audits & Drive growth

A single place to manage audits, suppliers, change management and more. Quality systems improve decision making when they provide you with the information you need to understand what's happening across your business, right now. This isn't possible using paper, hybrid or legacy solutions which keep data siloed in different systems.

That's why Qualio goes above and beyond to provide everything you need from a single, simple interface. It's closed loop quality like you have 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 several months and lots of money building a custom solution that underdelivers. We’ve painstakingly built Qualio to ISO & FDA best practices for easy configuration so you can focus on growing your business while we focus on quality.

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Contact Us about Qualio's Quality Management Software