QT9 QMS Out-of-the Box Solution
In 2020 Sunset began looking for a new quality management system to better equip them to reach their goal of ISO 13485 certification. At the time, the company was using a different software solution, combined with paper-based processes, to run and manage their quality processes. After a brief search, they ultimately chose to implement QT9 QMS based on ease of use and out-of-the-box capabilities.
Joe Consoli joined Sunset as their new Director of Quality and Regulatory to help build out the new QT9 system. Consoli, who has worked in the quality management arena for more than 30 years, was given the immediate task of moving the company into ISO 13485 compliance and certification.
“When I came into this role,” he recalls, “we were able to get our quality data loaded into QT9, get people trained on it, and get us to the point where we were able to go through our pre-audit and then our full ISO 13485 certification with no major nonconformities – all within less than a year.”
Sunset’s quality team was especially happy that the QT9 system did not require customization to begin using. Consoli noted that QT9 QMS’s built-in FDA 21 CFR 11 capabilities, in particular, made the transition easier.
“We didn’t have to do any customizations with QT9,” he says. “QT9 was flexible enough for us to create a system that matches our requirements, and we were able to push everything quickly through because of that. That ultimately made validations and compliance much easier.”
Culture of Quality
Since first using QT9 QMS in 2020, Consoli and team have implemented and are working day-to-day in 18 of the 25-plus modules, streamlining and centralizing document control, monitoring and establishing training, and easily following up on customer feedback, ECNs, corrective actions, and nonconforming products.
Using QT9, Sunset has built a company culture where quality is a factor of everything they do. “I believe we’ve created a quality organization throughout our entire company that everyone has bought into,” says Consoli. “We can do things with great velocity with QT9. We are not overly bogged down with approvals or system requirements.”
For easy implementation, uncomplicated user interface, robust capabilities, affordability and top-notch customer support, Consoli believes QT9 QMS can’t be beat.
“We are using something like 17 or 18 of the modules right now, and we implemented only three years ago,” he says. “And customer support is just like the software, you never have to dig for a solution.
“I have worked in several systems over the years, and out of the box, QT9 is head and shoulders above the rest.”
— Joe Consoli
Director of Quality and Regulatory
QT9™ QMS is flexible for your business.
QT9 lets you choose modules based on what's best for your organization.
Modules for any business size
With multiple modules to choose from, there's solutions for nearly anyone.
A solution that scales with you
Whether you are a large corporation or a small start-up you can use as many modules as you want.
Cross-Platform Support
Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.
