How 30 Technology found the perfect eQMS for faster, smarter quality management

Who are 30 Technology?

Headquarters
—Oxford, UK

Company size
—10-50

Industry
—Medical Device & Pharmaceutical

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30 Technology is a UK-based developer of therapeutic nitric oxide products.

With a medical device in development and laboratory-driven pharmaceutical products as well, 30 Technology has a complex double regulatory landscape to navigate.

Key operational standards include:

ISO 13485
ISO 14155
UK Medical Devices Regulations 2002
UK Statutory Instruments
FDA and EU Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)

The challenge

30 Technology has two products in development for the market.

But a heavily paper-based QMS meant a slew of time-heavy manual processes which cluttered and complicated compliance, as Head of Quality & GxP Compliance Karen Hue discovered when she joined the business.

Everything was very paper-based.

It would be: creating a document, signing it, having to distribute it somehow without any real control.

There was no metadata to tell me who'd got it and what version it was.

— Karen Hue, Head of Quality & GxP Compliance, 30 Technology

The solution

Two weeks after joining 30 Technology in November 2020, Karen led the search for an electronic quality management system (eQMS) and approached three vendors after a Google search.

Karen was impressed by Qualio and had a detailed discussion about how Qualio's software would fit into 30 Technology's operation, including cost, users and scalability potential.

After a rapid implementation and validation process, Karen and 30 Technology's Qualio system went live in mid-December and was christened Fort NOx: a nod to Qualio's security credentials and 30 Technology's nitrous oxide product base.

By January, all users were fully trained and accessing Qualio on a daily basis - less than two months after Karen's search began.

The results

Qualio delivered dramatic operational results for Karen and the 30 Technology team.

We run virtually our entire company through Qualio.

You don't realize that it would've taken half a day to do what you're now doing in 5 minutes.

— Karen Hue, Head of Quality & GxP Compliance, 30 Technology

Karen achieved ISO 13485 certification within just 6 months by integrating her entire quality management system into Qualio, cutting hours of admin time from her working week and saving 3 full-time salaries from 30 Technology's bottom line.