Leading biotech QMS software: streamline your quality

Develop life-saving treatments with a purpose-built biotech eQMS. Qualio streamlines your document management, lab investigations, suppliers and more.

Biotech QMS solution for a quality-centric operation

90% of our customers note boosted quality efficiency with our biotech QMS software



Biotech quality management professionals face the difficult task of ensuring the safety, efficacy and compliance of their products. But many are restrained by legacy quality tools that hinder the transfer and integrity of key data and information.

This blocks your ability to efficiently release your products - increasing costs and slicing your profitability.



Qualio removes the complexity of insufficient quality tools by providing the leading biotech quality management solution.

Qualio keeps you compliant and gives you a single source of trusted quality truth. It integrates with your other business-critical apps and gives you back your time to focus on evolving regulations, best practice, continuous improvement and growing your business.

Biotech QMS application to lift the lid on growth

  • Future-proof your company with a biotech QM platform that scales with you
  • Build a single source of truth for sharper collaboration, transparency and traceability
  • Manage suppliers, audits and change control across your entire business in real time
  • Develop workflows to assign tasks and automate reminders for documents, training and more

Focus on the future, not paper trails

  • Onboard our industry-leading biotech eQMS faster than any of our competitors
  • Digitize your paper stack, quickly import existing content and organize your documents for simple collaboration in the cloud
  • Find the quality data you need in seconds
  • Submit a perfect biologics license application with a holistic and controlled quality approach

Keep up with a complex regulatory environment

  • Migrate your legacy QMS directly into Qualio for seamless compliance and auditability
  • Generate detailed reporting on training, overdue and completed activities, audit trails, change control, event and supplier management and more
  • Set periodic review cadences to conform to FDA, ICH, EMA and ISO requirements
  • Work with our team of seasoned QA experts to meet and exceed your quality goals

Biotech quality management resources


ICH Q8 compliance guide

Embed lasting quality by design to continuously improve and lift your biotech operation to new levels

Get my guide

ICH Q9 compliance guide

Get your quality risks under unshakeable control by applying ICH Q9 risk management best practice

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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 biotech QMS software users

We needed something that was user-friendly, easy to onboard new team members, and easy to get up and running. Qualio has surpassed our expectations on those metrics.
Stephana P.
VP of Quality, Alphazyme
"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."
Chris S.
Quality Manager, CureMetrix
Using Qualio allowed management to review work in real time, mentor our team and build towards ‘design-lock-ready’ processes far more quickly than with a paper-based experimental tracking system.
Christopher B.
CEO, Alphazyme
"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
"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"The impact was immediately felt in terms of version management and training. Qualio simplified things immensely."
Andrew B.
Director of Quality Assurance, VitaCyte

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