Customer story

Monarch Medical Makes Sense of Document Management With Greenlight Guru Quality

Monarch Medical chose Greenlight Guru for its MedTech-specific eQMS and unparalleled industry knowledge and customer service.

The Challenge

Monarch Medical needed to switch to a new QMS solution for a fresh start with a user-friendly eQMS.

The Solution

As part of their effort to establish a culture of quality across the organization, Monarch Medical chose Greenlight Guru Quality for its new eQMS.

The Results

The team at Monarch implemented Greenlight Guru Quality ahead of schedule, reduced their QMS documentation, and established a scalable system for the future.

Monarch Medical: Leading the way in precision insulin dosing technology 

Monarch Medical Technologies is the maker of the EndoTool Glucose Management System and is the leading provider of precision insulin dosing technology. The team at Monarch is on a mission to provide easy-to-use precision insulin dosing technology to patients around the world, improving patient outcomes and changing lives. They envision a world without insulin dosing errors, and are deeply committed to elevating the quality of care for every patient in need of insulin therapy while hospitalized. 

The Challenge: Monarch Medical needed a new eQMS

The team at Monarch Medical was already using a general-purpose eQMS before they partnered with Greenlight Guru. But because the solution was complicated—especially when it came to document management—and didn’t fit their needs, the company struggled to get buy-in from employees.

What they needed was a fresh start to establish a culture of quality—preferably with a solution that was user-friendly and would help drive adoption across the business and let the team realize its full potential. They also needed an eQMS that would keep them compliant from day one and help them solve the documentation challenges they had seen in the past. 

As Tara Burnett, VP of Regulatory Affairs and Compliance at Monarch Medical put it, “People just had no confidence in the old system. We knew we needed to find something that was scalable and user-friendly as we grow.”

The Solution: Greenlight Guru Quality

Monarch Medical chose Greenlight Guru Quality as their new eQMS. 

2-Nov-06-2023-04-55-50-9941-PMAdditionally, Greenlight Guru checked all their boxes for a scalable QMS solution: SSO capability, 21 CFR Part 11 compliance, and simple validation from an operational standpoint. But the team at Monarch also liked the MedTech-specific help they added to their software with customizable SOP templates and abundant industry resources 

And when it came to document management, Greenlight Guru Quality had them covered there, too. 

“We showed Greenlight Guru Quality to our QMS “super users” in the company. We showed them the saved views, the favorites, and the tags for document management, and everyone was absolutely excited,” said Burnett. 

The Results: An all-in-one solution built for the medical device industry

Greenlight Guru Quality helped Monarch reduce documentation within their QMS, eliminate redundancies, and establish a scalable document management system going forward. It also helped bring all their quality processes under one roof. 

“We were using Salesforce for customer feedback and had to heavily customize it to be FDA compliant,” said Burnett. “So it was nice to be able to switch to something that was already compliant. We use the automations in the complaints module and those have really helped us.”

They also appreciated the fact that there was no complex customization to go through before they got up and running. 


Streamlined Document Managment

The team noticed an immediate difference with the ability to apply tags and create saved views, making it easier to locate documents and records within their QMS. Eliminating those document search struggles has alleviated frustration throughout the organization and had a significant positive effect on adoption of the system. 

Burnett also noted that the intuitive training workflow has taken what used to be an hour-long job—assigning training for a new hire—and turned it into a 15-minute task. 

“The dashboard is wonderful. We like the saved views and the tags. And the workflow just makes sense. It was a tool that had everything we were looking for.” - Tara Burnett, VP of Regulatory Affairs and Compliance at Monarch Medical

A true partner in medical device manufacturing

On top of everything the software offered them, Monarch Medical has also appreciated the fact that Greenlight Guru has so many MedTech industry veterans working on their team.

“We looked at other QMS systems, but we liked that Greenlight Guru was made for the medical device industry. And the Greenlight Guru employees we talked to were just so knowledgeable, so friendly, so accommodating. It just really made it an easy decision for us.” - Tara Burnett, VP of Regulatory Affairs and Compliance at Monarch Medical

What’s Next for Monarch Medical?

With Greenlight Guru on their side, the team at Monarch Medical is ready to continue their mission to provide easy-to-use precision insulin dosing technology and improve patient outcomes.



Monarch Medical Technologies

Founded: 2003

Company Size: 50 employees

Device Type: Software as a Medical Device

HQ: Charlotte, NC

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