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Navigate BioPharma’s Digital Quality Management Success Story

MasterControl’s case study featuring Navigate BioPharma and their success story in implementing MasterControl’s eQMS.

A reliable quality and compliance program is an essential ingredient for success in the highly regulated and ultra-competitive life sciences industry. For companies like Navigate BioPharma Services, Inc., delivering innovative biomarker solutions and customized assay validations requires a quality management system (QMS) powerful enough to support quality and compliance at scale. To address this business challenge, Navigate BioPharma implemented a digital quality management system, which has empowered the company to improve efficiency, enhance auditability, and facilitate innovation.

The Problem: Establishing and Maintaining Quality and Compliance at Scale

Working with different sponsors who all have varying clinical trial requirements, Navigate BioPharma faces a variety of challenges and complexities. That means the Navigate BioPharma team must not only be operationally agile but also have a robust quality and compliance program. To ensure reliable quality control and oversight at scale, the company needed the flexibility and efficiency that modern digital quality management tools provide. Traditional manual processes were not sufficient in supporting the level of control the company requires to consistently produce reliable data.

The Solution: Implementing a Modern Digital Quality Management System

To address these challenges, Navigate BioPharma implemented MasterControl's proven electronic quality management system (eQMS). The robust digital quality management solution gives the Navigate BioPharma team the tools needed to scale and automate quality processes, enabling them to readily meet and even exceed regulatory expectations.

The eQMS has enabled Navigate BioPharma to automate and simplify document control, change control, training management, quality event management, and audit processes. By optimizing these critical quality activities, the company is now able to move work instructions and procedures through faster, obtain approvals more quickly, and ensure that authorized users can readily access all necessary documents.

The Outcome: Delivering Innovation Without Compromising Quality

By using a modern digital quality management system, Navigate BioPharma has enhanced its ability to deliver innovative, time-sensitive, and high-quality results. The implementation of MasterControl's industry-leading eQMS proved to be an essential investment, as it supports the quality controls necessary to produce consistent and reliable data. Additionally, the eQMS solution enhances the audit experience by providing an easier way to manage audit plans, agendas, reports, and findings, while also simplifying the process of tracking findings for closure. Additionally, quick retrieval of documents improves audit efficiency and streamlines the process.

Fueling Innovation With Built-In Quality and Compliance

One significant advantage of implementing a purpose-built digital quality management system is that it enhances innovation rather than hindering it. By having quality built into the foundation of the company, employees are freed up to focus on new technology and advancements without being burdened by manual tasks that can now be handled automatically by the eQMS.

Navigate BioPharma operates on the leading edge of technology and leverages automation to drive efficiencies within the business. By using a reliable eQMS, the company saves time and ensures more accurate and faster data analytics. The time saving that digital quality management affords not only improves efficiency but also allows employees to dedicate more time to valuable tasks, such as performing tests. For example, implementing automation in the laboratory has allowed lab analysts to gain back an estimated 10 hours per week that can now be spent on patient tests, according to Navigate BioPharma Director of Core Infrastructure Bill Bressler.

Refining the Focus on Quality

Quality is the foundation of Navigate BioPharma’s culture. A demonstrable commitment to quality is a key pillar of success that differentiates the company from other clinical research organizations (CROs). With the right quality systems in place, Navigate BioPharma is perfectly positioned to the reinforce the trust of its customers and enhance its standing as a reputable lab. With digital quality management, the company’s quality data and insights are utilized to drive continuous improvement, identify potential gaps in procedures, and implement timely updates or corrective actions to documents and processes.

Take Action: Unlock Innovation With Digital Quality Management

Just like Navigate BioPharma, your organization can benefit from implementing a digital quality management system. With the No. 1 eQMS in the life sciences industry, you can streamline your quality and compliance processes, enhance auditability, and unleash the potential for innovation within your company.

Don't let outdated, manual processes hinder your organization's growth and success. Embrace the power of digital quality management and unlock the full potential of innovation within your organization. Discover how a modern, robust eQMS can empower your company to deliver high-quality results, drive efficiency, and ensure compliance on a scale that meets the life sciences industry’s rigorous demands.

To learn more about the many ways digital quality management can transform your company, explore MasterControl's solutions or read the case study on Navigate BioPharma Services, Inc. Start your journey toward enhanced quality, compliance, and innovation by contacting a MasterControl specialist to learn what a modern eQMS can do for your organization.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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