How xCures built a compliant, controlled eQMS for their 2022 plans
xCures is a health and wellness start-up that provides an advanced algorithmic AI platform connecting cancer patients to targeted oncology treatment.
xCures works to upend the traditional challenges blocking patients in need from clinical trial access, such as location, logistics and a typical acceptance rate of around 5%.
By transforming unstructured and complex medical information into actionable data, xCures' AI engine matches patients with the most suitable of the 9000 cancer treatment options currently available, including clinical trials - then liaises with clinical trial providers, predicts the outcome and secures treatment.
xCures has a complex and multifaceted compliance landscape.
Dealing with vast amounts of sensitive healthcare data demands HIPPA, CCPA, GDPR and FDA 21 CFR Part 11 compliance, while xCures' software as medical device (SaMD) system prompted the business to submit their first 510(k) submission in early 2022.
The business was struggling to meet its compliance requirements with a paper- and spreadsheet-based quality system underpinned by manual training processes.
A sponsor audit found an incomplete and improperly organized QMS, which prompted Mike Trudnak, VP of IT and Information Security, to begin the search for a better way to manage quality.
We got beat up pretty bad for our lack of a QMS and the generally disorganized state of our compliance program.
I said, "this is not viable. We have too much skin in the game". As we're securing funding and growing and trying to move out of start-up status, we expect more and more sponsor audits and more FDA scrutiny.
So getting the compliance program under control was Task #1.
The xCures team is a mixture of IT, software, AI and medical oncological professionals - and so the need for an electronic quality management system was quickly accepted by Mike's colleagues.
Mike identified multiple eQMS vendors, but homed in on Qualio because of several key factors:
The xCures team wanted to focus on their day-to-day work with minimal software upkeep demand, making a cloud-based system a must
Qualio's mature integrations offering with tools like Jira simplified testing and evidence collection processes for the xCures team and was a must-have for VP of Engineering Bill Mahoney
Qualio's easy-to-use document management would allow the team to ditch unwieldy email chains and centralize information logically for their next audit
I could say, "guys, look at this audit report, we need to do something. Let's go and find a quality management as a service solution.
I've dealt with MasterControl and all those on-premise systems and I wanted none of that. I wanted to let you guys be the experts and let us focus on our core competencies.
xCures became Qualio customers in July 2021.
Qualio provided a rapid and straightforward onboarding process for Mike and the xCures team, allowing their new eQMS to be built and rolled out ready for the next phase of xCures' business plan.
By replacing spreadsheets with an intuitive and easy-to-use cloud-based platform, the groundwork could be laid for business-wide engagement with quality - strengthening xCures' compliance for their FDA approval journey.
Mike identified his favorite Qualio feature as the new and improved document editing functionality, allowing QMS documents to be built, manipulated and securely distributed on the fly from within Qualio.
It was super-easy. Qualio did all the heavy lifting and we just grabbed the validation package.
And honestly: unless you're getting some competitive advantage or you can point to some specific regulatory mandate for taking ownership of it yourself, this is what Qualio does.
We're in the business of precision oncology. Certainly we need a QMS, but let the experts be the experts. Cut that check and move on!
To build a business case for Qualio investment and the move from paper and spreadsheets to a dedicated software platform, operational efficiencies and time savings were presented as a key ROI factor.
As expected, the xCures team noticed significant time savings after implementing their system, with Mike estimating hundreds of hours of admin time being sliced from the working year.
I'm wearing about sixteen hats here. So me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE.
Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!
xCures anticipates Qualio as being 'front and center' of their strategic goals for 2022, and can now look to tackle their upcoming FDA 510(k), SOC 2 and new sponsor audits with confidence, compliance and control.
Some software companies sell you a system and completely take advantage of you. That's not what we got with Qualio.
Everyone's walked away happy.
