02.3.2022 Jonah Krakow

    Selux Diagnostics enjoys fast, trouble-free audits after switching to ZenQMS

    About Selux Diagnostics

    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.

    Business Need

    As a start-up medical device company, Selux Diagnostics 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 progresses, and the team at Selux Diagnostics experienced those same 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 eQMS that could help, Ellin’s experience with a large, well-established eQMS company caused her to steer the team elsewhere. “I know it’s a very powerful system,” says Ellin, “but it was really hard to use. And 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 a quality management system 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 Diagnostics has seen an upgrade in the speed and accuracy of their document management and training, including how they better manage their design history file. However, Selux noticed benefits even before they migrated into the new system. During the vetting process, Selux spoke to current users to confirm their satisfaction with the system, but what really sold Selux 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, customizable workflows, and excellent customer support (“10 out of 10”, says Ellin), Selux has also seen an immediate increase in ROI related to their Quality audits. As Ellin 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. “Our auditor couldn’t say enough good things about Zen,” she added. Selux also appreciated having the ability to quickly and easily confirm their entire team’s training status to manage day-to-day compliance.

    When asked if managing quality inside ZenQMS was 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 medical device company need an upgrade to its QMS? If so, book a demo and find out how.



    Published by Jonah Krakow February 3, 2022
    Jonah Krakow