Digital Quality Management Enables Innovation at Navigate BioPharma Services, Inc.

At Navigate BioPharma, the commitment to quality is a key pillar of success which differentiates it from other specialty clinical research organizations. “Quality is one of our most important competitive advantages,” said President and General Manager Arkadius Pichota.

An EQMS With Built-In Compliance

“We want to make sure we’re doing right by the patient and performing within the bounds of those regulatory agencies and making sure that we put quality at the top of our list."

MasterControl’s enterprise quality management system (EQMS) helps Navigate BioPharma scale and automate quality processes. Navigate BioPharma has built a robust quality system and compliance controls to ensure their practices meet and exceed the regulatory standards their pharma and biotech partners need. This expectation applies to clinical trial testing and sample management processes as well as the need to produce accurate and timely supporting documentation. A fit-for-purpose EQMS is the best choice to manage and simplify document control, change control, training management, quality events, and audits.

“We’re bringing on new assays and we have to have the work instructions,” said Director of Quality Assurance Melinda Resh. “We have to have all the procedures that are related to that. MasterControl has enabled us to move those through faster so that we can get those approvals faster and those documents are ready to go quickly to enable us to start doing the patient testing.”

She also noted that any quality audit of a clinical laboratory could easily be impacted by incomplete, missing, or outdated documentation. “Obviously, it makes it very difficult unless you do have a quality (document management system). By having a system in place such as the MasterControl EQMS, it just enhances the whole audit experience,” Resh said. Not only that, but the audit management software component of MasterControl provides users with a way to manage the audit plan, agenda, report, and findings, as well as track findings to closure.

“The other advantage to going digital is it improves your auditability and your audit efficiency (because) you can quickly retrieve documents.”

Having robust training controls is also important, both in terms of day-to-day operations and when it comes to compliance. Navigate BioPharma ensures training compliance is both timely and complete. Rather than using a spreadsheet to manually track training and email out training tasks, Navigate BioPharma utilizes the functionality within MasterControl’s EQMS to automate the process. Supervisors can always see who is behind on their training and can immediately pull the records that demonstrate training completion.

Digital Quality Management Encourages Innovation

“By having quality built in, it doesn’t stymie innovation at all. In fact, it enhances it,” Resh pointed out. Built-in quality frees up employees’ time to focus on new technology without being hindered by things that are easily done in an EQMS.

Navigate BioPharma operates on the leading edge of technology, and leverages automation where it will have the most significant impact to help drive efficiencies within the business. One of the ways Navigate BioPharma is creating efficiencies and saving time is by using MasterControl’s EQMS for more accurate and faster data analytics. “When you implement automation, generally one of the biggest returns on your investment is time. ... That’s time that you can devote to things that add value. (For) a lab analyst, you can give them back 10 hours a week because you’ve automated. ... That’s 10 hours more time they can spend doing (patient) tests,” said Director of Core Infrastructure Bill Bressler.

“We use quality data and insights from potential issues or audit findings where we can always look to employ continuous improvement in whatever we’re doing,” said Associate Director of Digital Pathology Solutions Team Jennifer Bordeaux. These data and insights have helped Navigate BioPharma spot trends over time, identify potential gaps in procedures, and remedy them by implementing timely updates or corrective actions to documents and processes, reinforcing the integration of quality, compliance, and continuous improvement.

“We’re driven by data and quality and really making a meaningful impact for patients and hopefully to improve and extend patient lives with the work that we do here.”

Continued Focus on Quality

Quality is clearly engrained in the culture at Navigate BioPharma. “Quality is the foundation of our company strategy and is also the foundation of realizing our vision to become one of the most trusted and reputable labs for biomarker solutions,” said Pichota. “Without the right quality systems, we would never be able to earn the trust of our customers, and without that, we would never be able to be a reputable lab.”

“Quality is the foundation of our company strategy and is also the foundation of realizing our vision to become one of the most trusted and reputable labs for biomarker solutions.”

Of course, Navigate BioPharma employees see their organization as more than a lab. They aren’t just running tests for pharmaceutical and biotech sponsors — they’re helping find solutions for unmet medical needs that ultimately serve patients. Their work relies on scientific expertise and is driven by quality while ensuring data integrity.