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 keeping your teams 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 a paper-based system?

With the pace of innovation accelerating, pharma companies need a QMS that scales with them and embeds unshakeable compliance.



Qualio makes it easy to manage pharmaceutical quality demands, from GxP to ICH, 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 always be compliant with detailed reporting on training, change control and audit trails.

An end-to-end quality solution from development to production

  • Embed automatic 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 rapid and simple, making onboarding easy 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 an in-system web editor

Comply with everything

  • Generate detailed reporting on training, overdue and completed activities, audit trails, and change control
  • Set periodic review cadences to embed GxP and meet FDA, ICH and ISO requirements
  • Assign CAPA-related tasks to your team and track to completion
  • Accelerate your route to market with support from our quality experts

Pharmaceutical quality management resources

Pharmaceutical quality management software datasheet

Pharmaceutical quality software datasheet

Learn how Qualio provides a holistic and integrated PQS for your business.

Get my datasheet

ICH Q10 toolkit

Access a range of resources to kickstart your ICH Q10 compliance journey, from a step-by-step checklist to a detailed preparation guide.

Get my toolkit

Don't just take our word for it!

Hear from our happy pharmaceutical customers

“My favorite thing is how Qualio keeps us in a constant state of audit readiness.”
Deb G.
Director of Quality, Dimension Therapeutics
"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics

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Your pharmaceutical QMS needs to make your FDA and ISO auditors happy. Find out how with our webinar recording.


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