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Digital Transformation in Manufacturing: Breaking Down Silos With Connected QMS and MES

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In today's digital age, businesses are continuously seeking ways to integrate advanced technologies into their operations. The manufacturing sector in particular stands to gain significantly from digital transformation by connecting ecosystems. This post explores the importance of integrating quality management system (QMS) and manufacturing execution system (MES) software to achieve a truly connected manufacturing environment.

Building a Connected Quality and Manufacturing Ecosystem

Recent discussions across the industry, such as those in a MasterControl-hosted webinar, shed light on the journey toward digital maturity in manufacturing. The key aim is to break down silos and foster a more integrated and efficient manufacturing ecosystem.

Presenters Nicole Sherman, Caitlin Minton-Smith, and Jessica Madsen from MasterControl shared their insights on moving toward a digitally mature, connected manufacturing environment. The webinar’s primary focus was on bridging the digital divide in manufacturing by leveraging advanced technologies to connect disparate systems and achieve a seamless flow of production information.

Understanding the Digital Divide

Although we live in a world where digital technologies are integral to everything we do, the manufacturers, especially in the life sciences, often lag in adopting new technologies. Many processes remain paper-based and prone to errors that could be avoided with digitization. McKinsey reports that life sciences companies trail behind other industries in digital maturity, often due to a lack of data resources and an overall culture that is unprepared for digital transformation at scale.

However, there are areas where technology has been fully embraced, such as in the research and development of pharmaceuticals. Advanced technologies like artificial intelligence (AI) are now being used for drug discovery, medical devices incorporating patient data predictions, and personalized drug production. Despite these strides, quality and manufacturing departments that have become conditioned to working with paper often lag behind in digital transformation.

Research Insights on Digital Maturity

To understand the digital divide, MasterControl conducted extensive research, surveying over 300 quality and manufacturing professionals across life sciences sectors like pharma, medtech, biotech, and biologics. The study revealed that while 50% of respondents view digitization as a high priority and have some formal plans in place, the majority still fall into a “digital” category, indicating an intermediate stage of digital maturity that still lacks full connectivity.

The Digital Maturity Model

A digital maturity model was developed to help companies identify their current stage and future goals. The four stages of digital maturity are:

  1. Manual: Primarily paper-based and manual processes.
  2. Digital: Some processes are digitized with basic automation.
  3. Connected: Deep integration of all systems and software, enabling comprehensive data analysis.
  4. Intelligent: Autonomous data exchange optimized with minimal human involvement, leveraging advanced technologies like AI.

More than half of respondents desired to advance to the next level of digital maturity, highlighting a collective ambition toward full digital integration.

The Power of a Connected Ecosystem

A connected manufacturing and quality system ecosystem can lead to significantly better outcomes. Benefits include:

  • Improved Visibility: Sharing data and real-time visibility across departments allows for faster, better decision-making.
  • Efficient Workflows: Automation reduces manual errors and connects and accelerates processes, leading to faster production cycles and quality checks.
  • Cost Reduction: Fewer and easier to manage quality events, decreased manual errors, and less waste translate to substantial cost savings.

MasterControl’s Approach

MasterControl combines quality and manufacturing on a single, integrated platform. The MasterControl Manufacturing Excellence solution integrates seamlessly with its quality management system as well as with third-party systems like enterprise resource planning (ERP) and learning information management systems (LIMS), ensuring a seamless flow of data and operational transparency. The solution’s analytics engine further allows for robust data-driven decision-making by consolidating data from various sources.

Real-World Scenarios

Consider the example of updating your organization’s standard operating procedures (SOPs). With a connected system, an updated SOP is directly integrated into production processes, ensuring operators always have the latest information, thereby avoiding costly mistakes and rework. Another scenario involves managing deviations in production. A connected system can automatically notify quality management personnel when a deviation occurs, allowing for immediate action and preventing delays.

Starting Small

Transitioning to a connected ecosystem sounds overwhelming, but it doesn't have to be. Companies can start by digitizing smaller processes, like digitizing their logbooks, and then gradually expand to more comprehensive systems. Selecting providers who offer robust integration strategies will ensure future scalability and connectivity across all operations.


Embracing digital transformation in manufacturing through connected ecosystems can boost your continuous improvement efforts and lead to enhanced operational efficiency and cost savings. Starting small and focusing on a step-by-step implementation can help overcome initial barriers and start you on the path to unlocking the full potential of digital manufacturing.

For more detailed insights, including a step-by-step guide to achieving digital maturity, explore MasterControl's executive report on digital transformation in manufacturing. This resource outlines how to align and connect quality and manufacturing processes for optimal outcomes.


MasterControl Inc. is a leading provider of cloud-based quality and manufacturing software for life sciences and other regulated industries. For three decades, our mission has been the same as that of our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality and manufacturing processes. Innovative MasterControl tools have a proven track record of improving product quality, reducing cost, and accelerating time to market. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze and interpret large amounts of data, and visualize business insights in real time.


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Enjoying this blog? Learn More. Webinar: Break Down Silos, Build a Connected Quality and Manufacturing Ecosystem

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