Use Cases

Designed for growing life sciences organizations. Qualio is the QMS that quality teams love to use.

See Proof
Medical Device Manufacturers

Bring high-quality medical devices to market quickly with low-risk

Medical device companies need to implement a scalable QMS that is simple to start, and scalable as they grow so that they can get their products to market without delays or issues. Qualio has everything you need to be successful.

  • ISO 13485 / FDA CFR Part 820 quality system;
  • Design control and risk management;
  • Real-time web-collaboration features.
Pharmaceutical R&D and manufacturing

Bring your team, tools, and data together so you can scale gracefully

Pharmaceutical companies know that manual and legacy quality-systems often create bottlenecks as companies move from R&D to clinical trials, manufacturing, and distribution. Qualio can help you improve and automate your processes to support your growth so you can scale gracefully.

  • Automated workflows to streamline quality management;
  • Real-time web-collaboration features;
  • Reports that provide full visibility into performance.

Bring a quality-driven approach to every stage of the life sciences supply chain

Identify, investigate and resolve product-quality related issues so that you can improve company performance. Easily share progress and performance against KPIs so that you can highlight wins and areas that need attention.

  • Non-conformance, deviation, complaints, and CAPA;
  • QMS processes linked to change management;
  • Seamless link between processes.

Move away from disconnected systems, tools and data sources. Qualio is everything you need to meet your quality goals in one place.

Qualio offers a single place to manage all your quality activities

When you need to complete a quality activity you can start with Qualio.
You can create documents, approve them with digital signatures, and easily capture training.
Non-conformances, deviations, and complaints can also be initiated, investigated, and resolved with CAPA.

Take the right actions at the right time

Guided workflows ensure you know what to do and when to do it.
Notifications let you know when you have an action to complete, and reminders with due dates ensure nothing slips past.
View all your in-progress work when you sign-in so it's easy to continue from where you left off.

Real-time web collaboration without limits

Bring your team and stakeholders together to work on quality activities, no matter where they are.
Real-time collaboration over the web enables teams to work effectively, without the need to schedule meetings, conference calls or create long email threads.

Understand how you're doing at all times

Powerful reports provide a clear view of how your team and company are performing.
Quickly identify gaps so you can take action before an audit.


FDA & ISO Ready

Built to Best Practices

Qualio was developed from the ground up using modern technologies and the latest industry best practices to ensure easy compliance with FDA regulations and ISO guidelines. Quality is in our DNA.
Live in 60 Days

Concierge Onboarding

Go live in 60 days with Qualio. Our concierge onboarding gives you everything you need to be successful; including setup, migration, validation, and training.

Request a Demo

Let us show you modern quality management software that is simple to set up, scalable as you grow, and loved by quality teams all over the world.

Bring your team, tools, and data together. Make compliance a breeze and ensure nothing gets missed.

Contact Us about Qualio's Quality Management Software