Bring safe and effective drugs to market faster

Create life-saving drugs with an eQMS purpose-built for pharmaceutical companies. Qualio streamlines your quality processes while helping teams stay compliant with FDA, ISO and GxP regulations.

eQMS for pharmaceutical companies



Pharmaceutical companies are often forced to make difficult choices about quality management: work across multiple, siloed modules or slow down progress with paper-based systems. With the pace of innovation accelerating, pharma companies need a QMS that can scale as they grow.



Qualio makes it easy to manage quality processes, no matter how many products you have. With flexible workflows and templates tailored to your needs, our platform scales with your team. And you’ll stay compliant with detailed reporting on training, change control and audit trails.

A comprehensive quality solution from development to production

  • Enable quality with an all-in-one platform that scales as you add new drugs, departments and suppliers.
  • Unite your team, tools and data for effective collaboration across your supply chain.
  • Create and execute workflows for document approval, training and more.
  • Manage suppliers, audits and change control across your entire business in real-time.

Developing drugs is hard, using Qualio isn’t

  • Implementing Qualio is simple, making onboarding fast for your team members.
  • Migrate your legacy QMS painlessly and digitize all your documentation.
  • Quickly generate release documentation with a single click.
  • Streamline document management and collaborate on files with a simple web editor.

Support for compliance with all regulatory standards

  • Generate detailed reporting on training, overdue and completed activities, audit trails, and change control.
  • Set periodic review cadences to conform to FDA/ISO requirements.
  • Assign CAPA-related tasks to your team and track progress through to completion.
  • Speed up drug delivery with support from our quality experts.

Have quality and regulatory
experts on your side

Add Qualio+ to any plan and receive expert quality assurance
support to help growing companies get to market faster.

Regulatory content

Pre-configured templates and pre-written documentation for FDA & ISO compliance.


Quality assurance experts

Access to our team of quality experts to ensure you meet and exceed your QA goals.

Don't just take our word for it!

Without Qualio we would not have been able to achieve our critical milestone of ISO 13485 compliance before the end of 2015. We are now prepared to take the next steps towards compliance with European regulatory requirements and the CE mark.
Jonas T
Quality Manager
“My favorite thing is how Qualio keeps us in a constant state of audit readiness.”
Deb Glancy
Director Of Quality, Dimension Therapeutics
The Qualio sandbox worked as designed, the UI is actually very user-friendly. I was able to go into a sandbox and immediately start using it productively. It’s very easy to use compared to a lot of the other systems we looked at.
Adolfo Ramirez
Director of Information Systems and Data Compliance, IRISYS
It was pretty much a unanimous decision to go with Qualio right from the beginning.
Gene Vought
Quality Manager, Cirris
Any intelligent person would look at Qualio and say, ‘This is exactly what a cloud-based system should do. But when you actually see it in action, you still think it’s pretty cool.
Andrew Levien
CEO, ArcScan
I wanted a system that was quickly learned, quickly trained, and expandable, and Qualio hit all of those needs.
Gareth Quinn
Director of Quality, iMIX

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