How Hart Biologicals Cut Audit Prep Time in Half with a Purpose-Built QMS Platform

Hart Biologicals is an industry-leading manufacturer of haemostasis testing devices in international markets around the globe. 

When choosing an eQMS software provider, Hart Biologicals needed a connected platform that was purpose-built to help meet medical device regulations across multiple end markets and support their scaling business. 

Hart Biologicals: Your partner in haemostasis testing

Hart Biologicals is a UK-based manufacturer of ​in-vitro diagnostic (IVD) products for use in the detection, prevention, and monitoring of a number of medical conditions related to haemostasis and platelet function. Founded in 2002, Hart Biologicals’ expertise, robust quality system, solid infrastructure, dedicated staff, and state-of-the-art manufacturing facilities have attracted partners ranging from small start-up companies and universities to large multinational corporations.

Hart Biologicals’ products are based upon whole blood or blood plasma clotting technology or whole blood and platelet-rich plasma aggregation and platelet function test principles—technologies that are available in almost all pathology laboratories worldwide.

The Challenge:

The QA/RA team at Hart had hit a hard stop—their paper-based approach to managing quality tasks was beginning to cause significant inefficiencies across the organization. The quality manager, Petra Elischer, found herself chasing down documents, desperately trying to collect signatures, and having to continually remind employees to complete crucial industry training.

Even with the addition of multiple disjointed tools, this process only became more complicated. As a result, product development slowed down, nonconformances began piling up, and the threat of lost revenue due to incomplete compliance activities seemed to hang in the balance. 

The Solution: Greenlight Guru’s Modern QMS Software

For Hart Biologicals, the shift to a more efficient approach required a connected, end-to-end system that provided visibility into all of the quality events shaping their business. Greenlight Guru does just that, enabling medical device companies to digitally track and manage quality events, ensure key documentation is audit-ready, and drive traceability throughout all essential processes.  

And with products in multiple international markets, the Hart team also needed to be sure the eQMS solution aligned with the varied regulatory requirements, standards, and best practices in medical devices. Thankfully, Greenlight Guru was purpose-built to their needs as an IVD company and comes both compliant-ready and prevalidated.

The Results: Benefits of Using Greenlight Guru

By choosing an eQMS solution, Hart Biologicals has been able to streamline its quality management processes, resulting in increased efficiency and effectiveness across its operations.

No more outstanding nonconformances

Prior to using Greenlight Guru, Hart Biologicals had non-conformance files that had been open for as long as 5 years. Not only are all those now resolved, but there are also zero non-conformances older than 90 days.  “It’s easy to open the non-conformance file to solve the issue,” Petra said. “Everything is connected in the system and tasks can be easily assigned.”

Audit prep time cut in half

Hart Biologicals saw a 50% reduction in the time it takes to prepare for external audits, a number they attribute to the streamlined workflows and essential audit templates. These features provide on-demand access to documentation and ensure alignment with regulations, allowing audit teams to stay ready by keeping up-to-date procedures and records at their fingertips.

“The solution already has the right templates built-in so that they don’t have to write all of the reports and prepare the documentation from scratch each time there is an audit,” Petra said. 

Design and development is 75% faster

Hart’s previous paper-based system had made managing the many elements of product development and design tedious. Upon switching to Greenlight Guru, those inefficiencies became areas of strength—resulting in a development process that is now 1.75x faster.

“This is huge time savings. The workspace is amazing in connecting everything between all documentation, and it guides us all the way through to product registration,” said Petra.

Quality is now everyone’s job

The quality team has praised Greenlight Guru for giving them their time—-and sanity—-back. Petra reported that employees are now happily sharing the responsibility of the quality management process through tasks and virtual training that can be completed within the Greenlight Guru system, meaning no more chasing folks down for individual signatures.

“All of our documentation, quality events, and training materials are connected in the system, and this makes it clear who is responsible for each action. Rather than saying, ‘Oh that’s not my department,’ people are now drawn into the process,” Petra said.

What’s Next for Hart Biologicals?

Hart Biologicals has continued to develop, progress, and grow as an industry leader in haemostasis testing, particularly in the niche market of platelet aggregation testing. Greenlight Guru has made it possible for the company to safely and efficiently scale its products’ reach around the globe, and to keep their heart beating in sync with True Quality.