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ZENQMS KEEPS PRECISION MEDICINE GROUP, LLC AUDIT-READY ACROSS THEIR 40+ GLOBAL SITES
About Precision Medicine Group, LLC
With over 40 sites distributed across the globe, Precision Medicine Group, LLC (Precision) helps pharmaceutical and life sciences clients conquer product development and commercialization challenges in a rapidly evolving environment. The company deploys “precision medicine” methods and technologies to help innovator companies reduce time and costs and improve the success rate for delivering life-changing new treatments to patients.
Success Highlights
Business Need
Getting a company of 3,000+ global employees trained, compliant, and audit-ready is no easy task, but that’s exactly what VP of IT PMO John Shay and Project Manager Nicole Klee accomplish every day at Precision. The company has been growing exponentially for the past 12 years to include clinical research organizations (CROs), labs, and specimen storage facilities, among others.
Maintaining such a broad footprint across the clinical pharma development spectrum means Precision hosts multiple coordinated audits across the network annually. But doing so was becoming increasingly difficult without a way to absorb documents from business units and aggregate and manage those documents and SOPs centrally for the entire company. It was equally challenging to manage and report on training compliance across the organization. Adding to that, many of the business units within Precision were leveraging paper-based/manual systems.
With an increasing GxP audit and compliance burden and looking to simplify their training and document management process, Precision searched for a scalable electronic QMS with the functionality and features they needed at a reasonable price.
“A lot of the quality systems we looked at had a slick interface, slick workflows, and all the bells and whistles we’re never going to use,” said John Shay. “We didn’t need the kitchen sink. We needed function over fashion.”
Staying audit-ready was the key. Precision was looking for a central document management system, applicable at scale, that could satisfy industry requirements for producing training dossiers and provide evidence that their documents were being held in a controlled system with proper access and security. They also needed to be able to easily digitize imported SOPs from business units across the organization with a secure, scalable, and economical solution.
“We completed our analysis and landed on ZenQMS,” said John. “The features, functionality, and price point were perfect for what we wanted.”
Business Impact
As a Project Manager at Precision, Nicole Klee works closely with the QA team and has seen the positive changes ZenQMS has made to her day-to-day operations.
“The time it takes to prepare for an audit and execute audit requests has decreased exponentially,” said Nicole. “We’re no longer chasing down wet-ink signatures or going through training binders to see who’s out of date. That’s where I see the ROI. Because of the scrutiny of the audits we go through, it’s very significant.”
Moving to an electronic system has helped bring harmonization to Precision’s sites by putting all of their quality documents in one place and increasing training visibility.
“ZenQMS has made the lives of our managers and QA folks so much easier because the training matrix is intuitive and we can see exactly which groups everyone is in and what courses they’re assigned to,” added Nicole. “And it drives up compliance. Paper doesn’t turn red when you’re overdue.”
And Nicole isn’t shy about her appreciation for the ZenQMS support team, specifically when it comes to helping Precision’s new employees get trained and compliant once they’ve come onboard. “The ZenQMS help desk is fantastic, cordial, and prompt. We’ve had some tough one-off questions, and we powered through them together, so I always like to throw them some praise when I can.”
A topic that Quality Leaders can agree on (and one that often gets overshadowed), is the importance of Quality’s role in the financial health of an organization, and how a robust eQMS can help provide security and stability. John stressed how Quality should be viewed as the revenue protection engine, and that, in terms of budget priority, they deserve a seat at the table.
“People say, ‘You guys don’t generate revenue.’ ‘No, we protect revenue!,’ said John. “When we’re looking to sign a customer deal worth millions and they audit us, we have the evidence to show that we’re following proper processes, we have training procedures in place, and our documents are in a state-of-control. It’s how we measure and manage our business and ensure outsiders that we’re following good business practices.’ We protect the company’s revenue and ZenQMS is a critical component of that.”
“There’s no question ZenQMS has been worth it, 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”
- John Shay, VP of IT PMO
Regulated organizations of any size don’t have to struggle to find the features and functionality they’re looking for in a quality management system. Schedule a consultation with a ZenQMS sales representative and we’ll help find the best solution for you.