Use Cases

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

Medical Device Manufacturers

Improve quality, decrease time-to-market, and reduce risk

Medical device companies need a scalable QMS that is simple to start and delivers high-quality products to market without delay or issue. Qualio has everything you need to be successful:

  • ISO 13485 / FDA CFR Part 820 quality system
  • Design control and risk management
  • Real-time, web-based collaboration features
Pharmaceutical R&D and manufacturing
Unite your team, tools, and data to simplify quality and improve scalability

Manual and legacy quality systems create bottlenecks as companies move from R&D to clinical trials, manufacturing, and distribution. Qualio’s QMS platform improves and automates processes to reduce complexity and support growth and scalability:

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

Apply quality-driven approaches to every stage of the life sciences supply chain

Identify, investigate, and resolve quality-related issues to improve company performance. Easily share progress and performance against KPIs to 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

Qualio is your starting point for any and all quality activities. 
Create and approve documents with digital signatures. Easily capture training. Initiate, investigate, and resolve non-conformances, deviations, and complaints 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, scales with your business, and loved by quality teams across the world.

Unite your team, tools, and data. Make compliance a breeze. Always be audit ready.