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.

Website_biotech-hero@2x
amra-logo_color@2x
avectas-logo_color@2x
biofidelity-logo_color@2x
biofourmis-logo_color@2x
centogene-logo_color@2x
ecm-logo_color@2x
enochian-logo_color@2x
expression-logo_color@2x
ginkgo-logo_color@2x
greenlight-logo_color@2x
imaginab-logo_color@2x
kartos-logo_color@2x
lunapore-logo_color@2x
oribiotech-logo_color@2x
passagebio-logo_color@2x
proscia-logo_color@2x
synthego-logo_color@2x
watchmaker-logo_color@2x

eQMS for biotech companies

Challenge

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 This outdated approach to quality doesn’t scale, and it holds companies back from releasing innovative new treatments. 

Solution

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
Website_design-controls-section2@2x
Website_design-controls-section3@2x

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
Website_design-controls-section1@2x
Website_design-controls-section4@2x

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 >>

Popular content for Biotech Professionals

Canva Design DAEqxSnsa2g-1

Guide

How to Prepare ISO 9001 Certification
Canva Design DAEq3tAyiIc

Blog

Extracting Natural Pharmaceuticals
Canva Design DAEqxSnsa2g

Checklist

Audit readiness checklist

Canva Design DAEq3H4dvu0

Podcast

From Lab to Launch podcast

Canva Design DAEqxTFRG2o

Case study

IRISYS Case Study: Helping Biotech and Pharmaceutical Firms Secure FDA Approval
Canva Design DAEqxSnsa2g-1

Guide

How to create a quality culture

What Biotech Experts are Saying

left-quote Created with Sketch.

We needed something that was user friendly, easy to on-board new team members, and easy to get up and running. Qualio has surpassed our expectations on those metrics.

Stephana Petrino

Vice President of Quality at Alphazyme

left-quote Created with Sketch.

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 at Alphazyme

left-quote Created with Sketch.

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 at Proscia

Join a Live Qualio Demonstration