If there’s one mission that Life Sciences companies have in common, it’s to help develop safer, more effective therapies for the patients who need them. It’s not easy. And it takes a commitment to continuous improvement to finally make it to the commercial stage.
But what if continuous improvement stops…improving? Relying on luck isn’t the answer. In the case of these life sciences companies with insufficient quality management systems, they recognized it was time for a change.
If your company is in need of a better solution, fingers crossed, you’ll find inspiration in their stories to make a change of your own.
Comprehensive Trend Analysis
How fitting that we start in Ireland! Bimeda is a manufacturer and distributor of animal health products, headquartered in Dublin, that has grown steadily to include 10 international manufacturing sites and markets in over 80 countries.
With such a large network of sites and customers, the company realized it was going to take more than a kiss of the Blarney Stone and a paper-based quality system to keep quality in a state of control. They’d have to implement an electronic quality management system (eQMS) to gain better efficiency and oversight.
Once they chose ZenQMS to meet their cloud-based eQMS demands, they saw immediate improvements, particularly in the effectiveness of trend analyses at their global sites.
“From a compliance standpoint, one of the things you can’t easily get from a paper system is trend analysis,” said Senior VP of Quality, Colin Baker. “Where we might have only done it once a year because it was a massive undertaking, we’re now able to have reviews once a month. We’ve set up our customer fields to where we can pull up these trends a lot easier and react faster.”
Enterprise-wide Training Visibility
When you’re defending an audit, 4-leaf clovers and lucky horseshoes won’t help if your quality system is a mess. And no one knows that better than VP of IT PMO at Precision Medicine Group (Precision), John Shay. He and his team at Precision host hundreds of audits a year across 40 international sites, and it’s on them to make sure their 3000+ employees are trained and compliant..png?width=800&height=200&name=CTA%20In-Line%20Banner%20(1).png)
To improve their quality processes and keep them running smoothly, John was in search of an agile, scalable eQMS that could keep pace with their rapid growth, without the unnecessary bells and whistles that add complexity and confusion for users.
“We needed function over fashion,” said John. “We completed our analysis and landed on ZenQMS. The features, functionality, and price point were perfect for what we wanted.”
With configurable modules that allow for better visibility and security across their entire enterprise, ZenQMS has helped the team at Precision stay coordinated and audit-ready, even as they continue to add to their stable of labs, CROs, and research facilities.
“There’s no question ZenQMS has been worth it,” said John. “Not only as an audit preparedness, readiness, and evidence production tool, but as a platform as a whole. It’s stood the test of time against all the audits that we’ve had, and it’s a part of every one of them.”
Intuitive Dashboards
Talk about bad luck. Associate Director of QA, Nick Kalogeras, had just started his role at Vanguard Clinical when he realized the eQMS they had in place was a little more than an expensive document repository.
“Simple things like developing SOPs, editing, and collaborating with people had to be done outside the system because they couldn’t be done internally. Everything was a manual and tedious process,” said Nick.
The eQMS wasn’t going to magically fix itself, so he had a choice to make: Continue to struggle on a failing eQMS or convince leadership that they needed to make a change. Fortunately, he knew he could rely on Vanguard’s CEO, Tiffany Sepp, to help him build a rock-solid case to present to the CFO for a system that better fit their needs.
That system was ZenQMS: more cost effective, more efficient, and a lot easier to use due to its simple design. But it wasn’t just Nick and his Quality team that loved the new system. General users from other departments found ZenQMS to be more intuitive than the previous eQMS, leading to higher rates of training compliance.
“ZenQMS’ clean dashboards make our end-users so much happier. They only need to be in the system for 15 minutes instead of an hour,” said Nick.
Predictable Pricing
Kelly Thomas, Head of Quality Assurance at Veru has seen it all and knows that Quality teams often get the short end of the shillelagh when it comes to getting money for process improvement.
“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,” said Kelly.
Traditional eQMS solutions have an a la carte pricing model for modules and seat licenses. But for growing life sciences companies, this type of pricing makes it difficult for Quality teams (and their CFOs) to predict the cost of the system year-over-year. It stops continuous improvement right in its tracks and forces teams with insufficient budgets to resort to seat license and password sharing. That’s when Quality teams get in trouble with regulatory authorities.
But Kelly doesn’t have to worry about that. ZenQMS provides access to all modules for all users right from the start—her team can take advantage of a true enterprise-grade quality management system without fear of cost overruns or risky, non-compliant behavior.
“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.”
If you’re ready to drive continuous improvement with an eQMS designed around what matters most to life science companies, schedule a demo with ZenQMS and find out more!