Manufacture cutting-edge treatments faster

Develop life-saving solutions with an eQMS purpose-built for biotech companies. Qualio streamlines your document management, lab investigation, 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 that create silos for different modules. This outdated approach to quality doesn’t scale, and it holds companies back from releasing innovative new treatments.



With Qualio, biotech companies can centralize all their quality management into one system. Firms can integrate people, tools and documents from across their business. Customizable templates and workflows provide flexibility without sacrificing efficiency. And audit-tested reporting means you're staying ahead of regulatory compliance.

A quality system to sustain your growth

  • Future-proof your company with a quality platform that scales with your success.
  • Establish a single source of truth for improved 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

  • Concierge onboarding means implementing Qualio is fast and painless.
  • Digitize your entire paper library and organize documents for collaboration in the cloud.
  • Dashboards and document search enables you to find what you need when you need it.
  • Generate release documentation like a risk analysis or traceability matrix with one click.

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 and change control.
  • Set periodic review cadences to conform to FDA/ISO requirements.
  • Gain access to our team of experts to ensure you meet and exceed your quality goals.

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!

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 Petrino
Vice President of Quality, Alphazyme
Using Qualio allowed management to review the work-product 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 Benoit
CEO, Alphazyme
We especially liked Qualio’s history management that tracks changes to procedures and documents, and the configurable organization of documents that could be applied to demonstrate regulatory compliance.
Barbara Young
Senior Quality Manager, Proscia

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Learn why we have been ranked the quality management platform of choice