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.

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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

  • Save time and resources by utilizing our expert quality team.
  • Get up and running quickly and through validation in record time.
  • End-to-end concierge service from SOPs, gap assessments, to internal/supplier audits and more.

Learn more about Qualio Plus >>

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What Pharma Experts are Saying

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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

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My favorite thing is how Qualio keeps us in a constant state of audit readiness.

Deb Glancy

Director Of Quality At Dimension Therapeutics

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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 at IRISYS

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It was pretty much a unanimous decision to go with Qualio right from the beginning.

Gene Vought

Quality Manager at Cirris

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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 at ArcScan

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I wanted a system that was quickly learned, quickly trained, and expandable, and Qualio hit all of those needs.

Gareth Quinn

Director of Quality at iMIX

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