GxP Lifeline

How MES Integrations Give Pharma Manufacturers a Competitive Edge


MasterControl’s recent webinar featuring the advantages of pharmaceutical MES integration services.

To stay competitive in an increasingly dynamic field, pharma and biotech manufacturers are implementing an array of beneficial technologies that enable them to automate and streamline production. But even the most advanced tools won’t give a manufacturer a competitive advantage if they are disconnected and if production operations are still reliant on paper-based processes or manual input from one pharmaceutical manufacturing software system to another. That’s why integrations are rapidly becoming the backbone of the most important technology trends in pharma manufacturing.

In a jointly hosted webinar, experts from Elemental Machines, a pioneer in laboratory operations (LabOps) intelligence platforms, and MasterControl, a leading provider of cloud-based quality management systems (QMS) and a new breed of manufacturing execution system (MES) solution, explored the key ways that manufacturing systems integration improvements can help pharma manufacturers operate faster and more efficiently.

“In today’s complex and highly regulated environments, it’s not just what you do to achieve your digital transformation goals, but the intelligent ways that you can speed up that journey,” said Kevin Ghiasi, who oversees global strategic alliances for Elemental Machines.

Obstacles to Establishing Efficiency, Quality, Speed, and Adaptability

Getting the most out of your pharmaceutical manufacturing software solutions requires integration capabilities that enable you to overcome common constraints and setbacks. In the webinar, Ghiasi and MasterControl SVP of Manufacturing Excellence Success Brian Curran pointed out three common challenges that pharma manufacturers can overcome by enhancing their manufacturing systems integration capabilities.

  1. Paper-Based Processes, Data Capture, and Transcribing Errors: “The number one problem that we see – and are trying to resolve – is paper,” Curran said. He added that the primary reason why so many life sciences companies are struggling with inefficiencies is because 80% of them are still reliant on paper-based processes and manual data capture and transcription.
  2. Disconnected Tools, Processes, and Systems: “We see a tremendous amount of automation and technology when we go on a shop floor, but what most people don’t see is the paper batch record and the lack of the equipment connected to the batch record because it’s paper, so it can’t be connected,” Curran said. That gap between digitized systems and unstructured and/or siloed data is the cause of countless errors and inefficiencies.
  3. Last-Mile Connectivity to Equipment and Assets: In most pharma manufacturing environments, data from sensors and other devices are typically entered manually into pharmaceutical manufacturing software systems of record. What modern MES integration tools enable users to do, Ghiasi said, “is to make that data available in an automated process.”

The Power of MES Integration

Curran and Ghiasi provided a host of examples of the value that data flow enhancements bring. They also showed how they can help pharma manufacturers gain new actionable insights and make better decisions faster. Some of the specific benefits of manufacturing system integrations the presenters addressed include:

  • How the combination of real-time usage data and production intelligence streamlines vital processes like equipment maintenance and has a direct impact on operational efficiency as well as cost and time savings.
  • How batch record errors, deviations, and corrective action/preventive action (CAPA) inefficiencies can be reduced by using connected systems that automatically capture environmental and operating conditions. When data was transferred manually into their old pharmaceutical manufacturing software systems, Curran said, “our customers reported anywhere from two to 17 errors per batch record. When you have that many errors, a certain percentage are going to turn into deviations and then a certain percentage of the deviations will turn into CAPAs. The goal is to get rid of as many errors as possible by not having them in the first place so you don’t have the deviation nor the CAPA.”
  • How digitally connecting data, processes, and systems unifies a manufacturer’s production and quality functions and creates added value by combining data in a larger data lake. Effective and robust MES integrations provide efficiencies for manufacturing plus the review and error reduction for quality, Curran said. “Being able to connect the data from equipment, which more often is associated with the shop floor and the operations group, lets you pull it automatically into the batch record so that the quality group sees it and knows there aren’t transcription errors,” he said.
  • How complete historical digital records can be maintained to ensure a continual state of audit-readiness and help manufacturers keep pace with evolving regulatory processes.
  • How new, advanced methods are enabling manufacturers to capture and maintain vital informatics prior to, during, and after the manufacturing life cycle.

Curran and Ghiasi also invited MasterControl Integration Sales Engineer Andy Beier to join the presentation to demonstrate the myriad ways the innovative Elemental Machines and MasterControl MES integration replaces manually recorded and siloed data with automated capture, monitoring, and tracking through connected systems.

Learn More About MES Integration

For a closer look at how manufacturing systems integration enhancements can increase visibility into your data and processes and help you spend less time doing manual work and more time making data-driven decisions, improving processes, and driving innovation, watch the full webinar: “6 Ways to Thrive in Pharma With Connected MES, EBR, and Other Manufacturing Integrations.”

2019-bl-author-james-jardine

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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