Eagle Biosciences sees real ROI after switching to a better fitting eQMS

Right Idea, Wrong eQMS:

Eagle Biosciences (EagleBio) is a company moving forward. They are in the midst of transitioning from their origins as a distributor of antibody and assay kits for research facilities to focusing more on the clinical marketplace. With a mix of established products and those developed under their own brand, EagleBio’s President Dan Keefe knew that implementing a robust electronic quality management system (eQMS) would put them in a better position to both attract the attention of larger clinical labs, and scale to meet their demands. 

“We needed a quality management system that would be more appropriate, ‘GMP-light’, if you will, because while we were still focusing on the research market in the short-term, we knew we’d be transitioning to the clinical space as an organization.” 

There was just one problem: The first eQMS they chose didn’t work out the way they’d hoped.

“Formatting was a huge issue. The customization wasn’t there. And I was hand-entering almost everything,” said Paige Rondeau, EagleBio’s Quality Assurance Manager.

“We didn’t get the flexibility we were expecting,” added Dan.

For a forward-thinking life sciences company with its eyes on growth, implementing quality management software was the best way to support their scaling operations. Unfortunately, they just didn’t receive any of the benefits. 

EagleBio was still entering, formatting, filing, and updating their quality documents by hand. If quality activities are still handled manually, what’s the point of paying for an eQMS? 

But maybe most concerningly, Paige discovered that the approved templates for issues and deviations she’d created could be edited after the fact.  In a controlled system, this is a giant security red flag.

After their one-year contract was up, Dan and Paige agreed that their current QMS software just wasn’t working the way they needed it to. A replacement was necessary. That’s when they found ZenQMS.

A Quality Management System that Works as Advertised

One of the basic promises of quality management software is that Quality professionals get more time to work on critical projects because the system simplifies and automates the tedious admin tasks that normally bog them down. That’s what Dan and Paige were expecting with their old system, and it’s what they actually got with ZenQMS.

“In the old system, everything was formatted as a PDF, including Issues and Change Control,” said Paige. “ZenQMS is more compatible with Microsoft Word, so editing and formatting is so much easier.”

The same can be said of how much more efficient document management and updates have been with ZenQMS. In fact, they’ve even saved money in the process.

“Every time there was a change [in the old system], it would require Paige to make updates on many different documents,” said Dan. “Then there would be a different change two weeks later, and she’d have to update those documents all over again. If we stayed with that system, we probably would’ve had to hire someone to manage it along with her.”

“Managing [the competitor’s system] took away from my ability to manage what was happening in the office – the quality work,” said Paige. “Our processes are a lot easier to manage in ZenQMS and we’re closing quality events much faster.” 

The Real ROI of a Connected, Compliant eQMS

The switch to ZenQMS means EagleBio can finally reap the benefits of a functional eQMS. From the start, they’ve seen more return out of their investment in ZenQMS than they could’ve imagined with their old system, including: 

• They’re able to close quality events much faster, saving time and redundant efforts
• EagleBio no longer needs to bring on additional Quality support staff, preserving resources.
• The Quality team used the time saved to create new processes that impact critical operations, such as equipment management. 

“I have time to build new processes that are compatible with ZenQMS, including a preventative maintenance and equipment management process using the Change Control module, which will get rid of more paper,” said Paige.

Training access and visibility also saw a major upgrade. Prior to ZenQMS, it was up to Paige to manage training events and on-the-job training (OTJ) by herself, slowing down training management and putting compliance at risk. 

“Our processes are much more streamlined, especially with approvals and notifications. There’s way more visibility. Employees can see their training status and are more aware of what they have to complete. Before, we couldn’t log OTJ, and I love that it’s a function in ZenQMS. I just click on the course and I can see who’s compliant.”