Veru is an oncology biopharmaceutical company headquartered in Miami, FL. Their focus is primarily on the clinical development and commercialization of oncology drugs for the management of two of the most prevalent cancers globally – breast cancer and prostate cancer – while at the same time being opportunistic in exploring additional new indications or disease areas.
Kelly Thomas, Head of Quality Assurance at Veru is no stranger to electronic quality management systems (eQMS) -- and she clearly understands the impact of a QMS in enhancing efficiency and minimizing errors from a compliance perspective. “In Quality, we hold things,” says Kelly. “Every day I hold a product back because of a deviation, and that costs money. When you’re paper based, those things take a long time to resolve.
That’s why she was excited that Veru was looking to use an electronic QMS from the beginning. From her decades of experience working in Quality, she’s run the numbers and has seen the benefits that an eQMS can bring. “Human error deviations drop about 80%, turnaround times improve around 75%, and accountability improves because the system notifies you every day regarding training due and SOPs.”
But even an informed buyer and experienced quality leader such as Kelly is confronted with the most confounding aspect of acquiring and implementing an eQMS: Executive Budget Approval, especially with the complicated and painful pricing formulas all QMS vendors pursue.
“The hardest part about getting an eQMS through and getting management onboard is that every time you add a user, you have to ask for more money,” says Kelly. “Even when the executive team is fully supportive and wants ‘best-in-class’ technology, by the fifth round of asking for more money, their appetite starts to wear down. Companies like buying equipment, manufacturing space, and reactors. Nobody likes investing in Quality. We’re not the easiest people to fund, even though we’re a requirement.”
The implications of this increasing budget friction is obvious, as companies begin to make choices for cost mitigation that may jeopardize their entire quality program. It’s a dilemma that Kelly is familiar with.
“In my other role as an auditor, I see it all the time. Companies run out of money, or they fail to support every user who requires a separate license, because it’s a very expensive seat to buy. Then budget concerns cause Quality to do things that are non-compliant, like creating a general password to ‘share seats’, and that’s when you get 483’s.” Even worse in some instances, when you force a small number of users to do all the quality work, you’re not really employing an ‘enterprise’ system that supports all stakeholders.
Kelly has implemented every type of system at companies of all stages, including start-ups like Veru, and has a keen sense of the strengths and weaknesses of each software platform. Tasked with establishing the company’s Quality system, Kelly took the advice of Veru’s Senior Vice President, Gary Bird, and booked a short demo with ZenQMS. She was immediately impressed with what she saw. “It was so much more user-friendly compared to other systems.”
“It was so much more user-friendly compared to other systems.”
Her positive experience continued even after validation and launch. “The document control and training is perfect. It executes simply and does exactly what you need it to do. And it was easy to implement and roll out,” she emphasized.
But it was ZenQMS’ pricing structure that really sealed the deal.
“I love your pricing because it’s straight-forward; there’s one upfront cost. I don’t have to constantly go back to management and justify why I need more money. You’ve streamlined all of the pain points that I’ve had in previous implementations. Great job making it very simple.”
Straight-forward pricing, coupled with an easy-to-use platform that met all of the company’s needs, helped Kelly get buy-in from her management team to expedite the approval process for this critical system.
But more importantly for Kelly and her colleagues, ZenQMS provides real world benefits to Veru. Because the platform allows access to all modules for all users right from the start, her team can implement a quality system that’s available to the entire company, without fear of cost overruns or unsanctioned user behavior that increases risk of non-compliance.
“You can’t implement everything all at once, so the ROI is that I don’t have to go back and ask for more money. I can use the QMS the way I want without worrying that leadership will shut down the expansion that I need. With ZenQMS, once you’ve bought the system, you’ve bought the whole system.”
To learn more about why ZenQMS’ simple pricing makes sense for growing Life Sciences companies, schedule a demo.