Manufacture cutting-edge treatments faster

Develop life-saving solutions with an eQMS purpose-built for biotech companies.
Qualio streamlines your document management, lab investigations,
batch records, suppliers and more.

eQMS for biotech companies



The challenges in the biotech industry don't stop at controlling costs and regulatory complexity.

Many firms are stuck working in multiple quality tools and battling through modular silos. This outdated approach to quality doesn’t scale, and holds companies back from releasing innovative new treatments.



Qualio centralizes your biotech quality management system into a single source of truth.

Integrate teams, processes and documents from across your business. Apply customizable templates and workflows for flexibility without sacrificing efficiency. And enjoy complete visibility of your quality landscape for airtight and constant compliance.

A quality system to lift the lid on growth

  • Future-proof your company with a quality platform that scales for success
  • 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

  • Get started quickly with industry-leading onboarding
  • Digitize your paper stack and organize documents for collaboration in the cloud
  • Find the quality data you need in seconds, from batch records to audit reports
  • Submit a perfect biologics license application with a holistic and controlled eQMS

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 and more
  • Set periodic review cadences to conform to FDA, ICH and ISO requirements
  • Work with our team of seasoned QA experts to meet and exceed your quality goals

Biotech quality management resources


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

How to evolve to a paperless eQMS

More and more biotech companies are turning to paperless quality management. Get started.

Get my guide

Don't just take our word for it!

Hear from our happy biotech customers

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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