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SELUX DIAGNOSTICS ENJOYS FAST, TROUBLE-FREE AUDITS AFTER SWITCHING TO ZENQMS
About Selux DX
Selux NGP (Next-Generation Phenotyping) is an advancement in Antimicrobial Susceptibility Testing from Selux Diagnostics. Their NGP device allows clinicians to identify and direct antimicrobial therapies to patients in as little as five hours as opposed to the standard timeline of three-to-five days. The accuracy and speed with which these treatments are prescribed allows shorter hospital stays for patients and helps end the downward spiral of antibiotic resistance while preserving the efficacy of antibiotics in treating infectious diseases.
Success Highlights
Business Need
As a start-up medical device company, Selux Diagnostics (Selux) began their quality journey on a manual, paper-based system. However, once they grew and moved into the clinical trial phase, leadership understood that migrating to an eQMS was a critical necessity.
The drawbacks of managing quality activities with manual or home-grown tools become obvious as a company matures, and the team at Selux Diagnostics became familiar with those headaches. Ellin Drouin works as a consultant for Selux and worked on the implementation of ZenQMS. In her words, “When using Docusign and shared files…a manual process, there’s a risk of human error.”
Printing and signing document change orders without knowing if they were the latest, correct revisions, and physically filing (and potentially misfiling) documents were some of the reasons why Selux was ready to move on from paper. At the same time, not all electronic quality management systems are created equal.
When Selux began their research into an electronic quality management system (eQMS) that could help, Ellin’s prior experience with a large, well-established vendor caused her to steer the team elsewhere. “I know [competitive eQMS] is a very powerful system, but it was really hard to use," said Ellin. "No matter how much training we got, people just couldn’t get comfortable with it.”
She and the Quality team at Selux were looking for an eQMS that was easy-to-implement, easy-to-validate, and easy-to-use. After doing their due diligence, they were convinced that ZenQMS would comfortably handle their needs.
Business Impact
Since moving to ZenQMS, Selux has enjoyed an upgrade in the speed and accuracy of their document management and training, including how they better manage their design history file. But what's more interesting is that Selux noticed benefits even before they migrated into the new system. During the vetting process, Selux spoke with current users to confirm their satisfaction with the system, and what really sold them was how user-friendly they found the workflows to be. In addition, the ZenQMS validation process was painless, making implementation that much easier.
“Our auditor couldn’t say enough good things about Zen.”
Along with an easy-to-navigate dashboard, configurable workflows, and excellent customer support (“10 out of 10!” said Ellin), Selux has also seen an immediate increase in ROI related to their Quality audits. As she recalls, their Quality Manager was able to pull 99.9% of everything the auditor requested right from ZenQMS, thereby reducing their scheduled audit time by almost an entire day. They also appreciated having the ability to quickly and easily confirm their entire team’s training status to manage day-to-day compliance. “Our auditor couldn’t say enough good things about ZenQMS,” she added.
When asked if managing quality inside ZenQMS has been easier than working with their home-grown system, Ellin couldn’t have been clearer.
“It’s 100% easier. As opposed to DocuSign, SharePoint and paper, in ZenQMS, you always know you’re looking at the most recent document, and you can see the audit trail for the approvals. It’s just much cleaner and we have a better feeling that our documents are more secure.”
Does your life sciences company need an upgrade to its QMS? If so, book a demo and find out how.