The #1-rated quality management system software

Learn why Qualio's cloud-based QMS software is used by over
650 life science companies to unite their teams, data and processes

Why adopt QMS software?


Modern life science quality is tough - and getting more tightly regulated all the time.

Your focus is always on efficacy and patient safety, but admin, manual upkeep and communication silos pull quality teams away from their vital work and make errors and costly compliance lapses more likely.

QMS software, provided by industry leaders like Qualio, replaces manual, time-consuming tools like paper and spreadsheets to lift your operational quality to new levels in a dedicated quality management solution.

Information and data are centralized.

Processes and documents standardized.

Admin eliminated and automated.

And your entire quality landscape connected for colleagues to collaborate, for auditors to see, and for natural, continuous improvement to take root.

Companies using our QMS software enjoy...

90% less quality admin

5x faster external audits

140% faster route to market

30% faster quality processes

Collaborative quality cultures


And more.

5 key things your life science QMS software needs

How to choose the right quality management system software for your business

1. Intuitiveness

Your QMS software investment is only as strong as the levels of employee engagement and support it generates.

Choose a quality management solution with ease of use at the forefront to build a culture of quality that lifts your business to new levels.

2. Connection

Modern life science businesses rely on a complex infrastructure of teams, systems and partners to develop and launch their critical products.

Pick QMS software that enables fast, scalable connection and collaboration - both inside your business and with external stakeholders.

3. Content-first

Content creation, editing, approval and control are central to any quality management process - and are often where inefficiencies and errors arise.

Look for quality management software that makes editing, collaboration and flexible data management natural and automatic.

4. Purpose-built

QMS software that's too generic, too rigid, or that's designed for giant enterprise operations won't yield the same results as a system that's purpose-built with the specific challenges of life science start-ups and scale-ups in mind.

Filter out platforms that don't fit your business.

5. Feedback

Real QMS software users are the best way to access unbiased insights and feedback.

Work with a QMS software vendor with plenty of social proof.


Our QMS software is trusted by growing
life science companies across the globe

Qualio is a holistic quality management system software platform, purpose-built for
medical device, pharmaceutical, biotech and contract research/manufacturing companies

Document management

Make paper, filing cabinets, folders and spreadsheets a thing of the past.


Supplier management

Control and categorize suppliers and third parties with complete visibility.


Design control management

Supercharge your product development from a single source of truth.


Risk management

Detect and mitigate risks and comply with
ISO 14971 and ICH Q9.


Training management

Build a competent, confident, compliant, continuously improving workforce.


Change control management

Manage change activity easily and effectively with complete traceability.


Audit management

Make compliance and audit readiness the natural core of your business DNA.


CAPA & NCR management

Build automated response workflows for any quality event.

Plus Line

30% faster quality processes
90% reduction in quality admin
140% increase in product release speed
5x faster external audits

And more.