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How Modern eQMS Solutions Are Powering Pharma’s Digital Revolution

How a digital EQMS helps the pharmaceutical manufacturing industry overcome challenges.

The intense pressures on pharmaceutical companies to accelerate their product introduction pipelines are nothing new. What’s unique in today’s industry is that companies must also contend with decreasing margins and an ever-widening range of personalized and hyper-sophisticated products. Because of modern challenges like these, companies are finding it necessary to reevaluate their traditionally siloed approaches to quality processes and quality management systems in pharma.  

Overcoming Pharma Manufacturing’s 3 Toughest Quality Management Challenges

Companies across the pharma industry are making efforts to adapt their quality practices to match the market’s increasing velocity. However, three factors are impeding many organizations’ attempts to connect the quality life cycle:

1. Tighter timelines:

Pharma companies that have undergone digital transformations in quality management move faster and are more adaptable than those still using paper — that’s no secret. However, as more tech-savvy companies join the fray, accelerating time to market has never been more crucial. Doing so, say the pharma experts at McKinsey & Company, will require the industry to overhaul its approach to drug development. “While there is no silver bullet,” McKinsey researchers wrote, “drug developers can make a concerted effort to apply and integrate multiple innovations that can transform development.” They estimate that digital solutions like enterprise quality management systems (EQMS) should make it possible to bring medicines to the market 500 days faster, giving companies a competitive advantage and accelerating the delivery of much-needed therapies to patients.1

2. Greater product complexity and diversity:

In today’s era of groundbreaking gene therapies and precision medicine, pharmaceutical products have reached new heights of complexity. And, given that specialty pharmaceutical products are projected to account for almost two-thirds of new product launches in 2023, tomorrow’s products will assuredly be even more complex. 2 Additionally, pharma products are also becoming more diverse and have shorter product life cycles than ever. Concurrent with these factors, is regulators’ increasing emphasis on outcomes and modernized delivery models. As products become more diverse and nuanced, the reliability and accessibility of the quality data that supports them must increase in equal measure. Advanced technologies like purpose-built pharma EQMS solutions will be key to managing quality data more effectively.

3. More personalized products:

Personalized medicine continues to be a gamechanger in pharma. The broadening field of patient-specific therapies is resulting in a massive increase in the flow of quality data. To handle the greater volume of data and avoid bottlenecks, quality teams require sufficient levels of automation for supporting continuous real-time capabilities. However, any technology that is implemented to streamline the handling of quality data must also be capable of making that data accessible and contextualizable. A modern pharma EQMS is the ideal tool to meet that need.

The Rise of Intelligent Pharma Quality Management Systems 

The demand for acceleration and the enhanced focus on data is bringing purpose-built quality management software front and center. It’s no longer enough to simply have point solutions for managing quality activities like document control in the pharmaceutical industry. Pharma companies need greater real-time visibility into data and more control over quality processes, especially as complexity increases and innovation speeds up. This is only found in EQMS solutions that connect all areas of quality — document control, change control, quality event management, training, audit management, and so forth.

Instead of various point solutions pieced together to coordinate multiple data streams and processes, an integrated pharma quality management system software solution offers the reassurance of native connectivity. EQMS connectivity allows organizations to unite quality applications, processes, and data within a common architecture and centralized database. What’s more, the organization enhances governance over quality processes by running multiple applications within an intrinsically linked operating system. This level of connectivity enables organizations to pull data together not only from different quality functions but from any department across the entire enterprise.

Enhancing Vision and Versatility With Pharma EQMS Solutions 

Decision-makers who can visualize what’s going on in real time can act quickly. The fact that increased speed depends on visibility was made painfully apparent by COVID-19. The pandemic forced companies to change how they work, and the pharma companies that had good visibility into contextualized data were prepared to meet the challenge. “Companies shattered previous vaccine development records due to their ability to capture, store, process, and analyze machine data,” said Deloitte Principal Aditya Kudumala.3

By enabling companies to achieve real-time quality intelligence, digital pharma quality management systems have proven to be the ideal mechanism for establishing quality as a speed-to-market accelerator. As pharma companies recover from the pandemic’s effects and position themselves for prosperity in the new normal, digitization provides adaptability and expansion when the need to evolve or pivot becomes necessary. Although your ability to be more responsive and flexible may not reach the same pandemic-level intensity, your business processes will inevitably evolve and require versatility. New processes always need to be added or old processes improved upon. With a robust, digitized EQMS, pharma organizations are well equipped for growth with a baseline technical framework that can be integrated with and expanded upon to catalyze innovation.

The Pivotal Role of EQMS in Pharma Manufacturing’s Digital Transformation 

A recent Cognizant industry report proposed that “digitization” will mean much more in the future than simply applying digital tools to business processes. Instead, it will entail a business reinvention via technology-enhanced connectivity between data, knowledge, people, and insights, which would result in the industry being more proactive overall. Cognizant researchers project that digital transformation will gain more steam as life sciences companies find new adaptive strategies to keep pace with competitors and provide higher-quality products. As Cognizant Chief Digital Officer of Life Sciences Brian Williams said, “Life sciences, we now know beyond a doubt, is far more agile than anyone could have imagined.”4

The same Cognizant report included research noting how far along (or behind) life sciences companies are in their digital transformations and adoption of powerful digital tools like pharma EQMS solutions, and where they’re hoping to be in 2023. Two compelling findings include:

  • 73% are implementing or using data analytics, but only 5% have widespread implementation.
  • 47% are implementing or using process automation, but only 5% have widespread implementation.

In light of the competitive state of the modern pharma industry, statistics like these make one thing clear: If your company isn’t at least planning on implementing an EQMS solution or other advanced digital tools, now is the time to start.

  1. The pursuit of excellence in new-drug development,” by Gaurav Agrawal, et al, McKinsey & Company Life Sciences Insights, Nov. 1, 2019.
  2. Powering Global Access: Building a Reliable, Efficient Pharmaceutical Supply Chain,” by AmerisourceBergen, Fierce Pharma, Nov. 15, 2021.
  3. Tech Trends 2021: Life Sciences perspective,” by Sheryl Jacobson et al, Deloitte Insights, 2021.
  4. The Work Ahead in Life Sciences: Cures at the Speed of Digital,” by Brian Williams, Cognizant, 2021.


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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