Medstreaming and M2S are now Fivos Health. Founded in 2006, Fivos is the industry’s leading provider of comprehensive data solutions for specialty providers, medical registries, and device manufacturers. By taking a holistic approach to data capture, insights, and action, Fivos helps drive innovation, improve outcomes and lower costs. Vascular, cardiovascular and other specialties can leverage Fivos solutions to manage workflows, assess performance, measure risk, and meet regulatory markers.
As a company well-versed in data capture and workflow solutions, Fivos was no stranger to the benefits of using an electronic quality management system (eQMS) to keep documents and training in a state of control. However, their eQMS solution, while powerful, was expensive and intended for use by much larger companies. Mike Seiler, Quality Manager at Fivos, was tasked with researching affordable eQMS options that would more appropriately match the size and scope of his company’s needs.
One feature at the top of his requirements list was that the new eQMS be cloud-based. At the time, Fivos’ system was housed at the company’s New Hampshire headquarters using on-site servers. This posed a risk as severe weather events are not uncommon in the Northeast. Along with other SOPs, Fivos stored their Business Contingency and Disaster Recovery plan on servers that, if a powerful storm hit and knocked out power, they would not be able to access. “Then what do you do?” said Mike. “You’re potentially housing documents outside of your document control application, which is certainly not best practice.”
After researching and viewing demos of ten available eQMS solutions, Mike and the company’s Chief Security Officer ultimately decided ZenQMS was their best option moving forward.
Having access to their Business Contingency and Disaster Recovery SOPs at all times is certainly a benefit that ZenQMS’ cloud-based platform affords Fivos. But the system really paid dividends at the beginning of the pandemic because their day-to-day operations didn’t stop.
“ZenQMS helped us perform company-wide training sessions, when we were all in the office, pre-pandemic. When everyone went remote for COVID, it truly shined a light on the need for accessibility. We’re a global company, which made it even more important.”
The simplicity of the ZenQMS dashboard also makes it efficient for global teams to understand their assignments or tasks and execute. “I work with teams in Egypt and India, and communication can be a challenge. With ZenQMS, I can write emails without specifying what it is they need to train to. Once they receive a notification, they can log in and the relevant information is right on their dashboard—front and center.”
ZenQMS’ ease of navigation also has benefits when it comes to audits, as Mike can attest.
“I’ve been through hundreds of audits. If you say you have something, you need to show it. Can you find it quickly and verify that people have trained to it?” Given the nature of their solutions, Fivos’ document control, CAPA, and training applications must all remain 21 CFR Part 820 compliant. Being able to navigate and find requests from regulators is critical because in Mike’s words, “ZenQMS is one-half to three-quarters of that audit.”
Aside from regulatory audits, there is business value in being able to quickly and confidently show control of your quality management system during a (virtual) customer visit as well. In Mike’s case, his ability to navigate the ZenQMS platform makes his job that much easier. “When I’m sitting with a client going through the system, it gives them a sense of comfort when I can easily locate what they need.”
On the topic of finding things easily, Mike wasn’t shy about his enthusiasm regarding ZenQMS’ keyword search functionality. “We asked for that from our old system eight years ago and it was never delivered. When we looked at ZenQMS and saw the capability, it was a game changer.” Keyword search is a necessity at a global company like Fivos, where people often title their documents differently, even when they pertain to the same subject. “It’s a feature that gets used all the time by a lot of people.”