Manufacturers in the Life Sciences industry are challenged with changing trends and the move to more personalized medicine solutions. Manufacturing execution systems (MES) play a critical role in optimizing the lifecycle of the production process from order through release for sale.

Johan Zebib joins me in this Emerson Automation Experts podcast to share how MES addresses many of the challenges for higher quality, and more efficient and reliable production.

Give the podcast a listen and visit the DeltaV Manufacturing Execution System section on Emerson.com for more information in driving great performance in your pharmaceutical and biopharmaceutical manufacturing operations.

Jim: Hi, everyone. This is Jim Cahill with another “Emerson Automation Experts” podcast. Manufacturing Execution Systems, or MES, help gain visibility and improve processes to meet production goals. MES increases visibility operations to accelerate batch release while ensuring repeatable production processes. In the highly regulated environment of Life Sciences, MES combines document, equipment, and materials management with electronic workflow to deliver an optimized manufacturing system.

While manufacturers aim for smarter operations, technology that enables digitization becomes more critical to success. MES enables connectivity of data across the enterprise to improve and streamline communication and collaboration. The automation of manual processes and digitization of data delivers real-time production information while helping to ensure quality and compliance.

I’m joined here today by Johan Zebib. Johan has more than 25 years’ experience in manufacturing solutions, mainly focused on Life Sciences industry. In his current role, Johan helps customers implement their vision of modern manufacturing operations while providing leadership to Emerson’s Life sciences MES business in Europe. Welcome, Johan.

Johan: Thank you, Jim. Thank you for having me. I’m excited to discuss MES and its impact on the Life Sciences industry here with you in this podcast.

Jim: Well, it’s great to have you to share your expertise with me and our listeners today. I guess to start, could you give us a brief overview of what a manufacturing execution system is and some of its key functions?

Johan: Yeah, certainly. A manufacturing execution system or what we call commonly MES is a software solution designed for the industry actually to monitor, track, and manage manufacturing processes on the shop floor. MES acts as a bridge between the enterprise-level systems that are focused on planning and the shop floor or the production floor. MES collects real-time data enabling better decision-making and improved efficiency.

The key functions of an MES are order management, material equipment and quality management, as well as performance analysis. MES helps in coordinating buyers, manufacturing activities, and ensuring that production runs smoothly. For instance, it manages resources effectively. It connects as well with scheduling systems to update them on the current progress of the production orders and then ensure as well the quality standards are met. This holistic approach to managing production processes is what makes MES an essential tool for a modern plant.

Jim: Well, that’s a really good overview. I picture this orchestrating and connecting between control and what’s happening and the planning and scheduling and all that. So it seems like that’s a very important component. So what benefits can companies expect from implementing an MES?

Johan: Yeah, indeed. Implementing an MES has lots of benefits such as increased efficiency in the production, improved quality, as well as enhanced traceability. Actually, MES helps reduce production costs, minimize waste and ensure timely delivery of products. Additionally, it ensures better compliance, particularly within the regulated industry sectors like Life Sciences. One of the key benefits as well of MES is the real-time visibility into production processes. This means that issues can be identified and addressed promptly, preventing costly delays and rework of the product that has been produced. MES also facilitates better collaboration across the different departments as everyone has access to the same real-time data, ensuring that decisions are based on accurate and up-to-date information.

Jim: Yeah. Those were a couple of really important points you made, especially that real-time visibility to keep the production on track as you go. That’s really important there. So speaking of Life Sciences, how is MES used in this industry, and what are the key functions in this case?

Johan: Yeah, indeed. That’s my domain of expertise, the Life Science industry. MES is essential for this industry for at least the following four key aspects. First one is the compliance. MES provides Electronic Batch Record Management, which we commonly call EBR, ensuring all production steps are documented and maintaining an audit trail for all the operations capturing as we progress into the production, who did what, and when.

Then secondly, on the quality side, MES integrates quality checks at various stages of the production, allowing for immediate identification and correction of deviations. MES helps as well in managing exceptions by recording them and facilitating the investigation and the collaborative resolution of those exceptions. Then thirdly, regarding the traceability, the MES systems ensure complete traceability of materials and products from raw materials to finished goods, which is essential in case of batch recall. Finally, on the resource management, MES tracks and checks the equipment in real time. It verifies their statuses at the point of use. It also provides real-time tracking of inventory as a resource helping in supply chain optimization.

Jim: Okay, I got it. So there’s compliance, there’s quality, traceability, and resource management. So since we’re speaking about the Life Sciences industry, how is MES particularly beneficial to the industry?

Johan: Yeah, MES helps managing the production processes according to defined master recipes. And master recipes in the Life Science industry is a key element of the way we are to produce a product. So the MES streamlines the operations and enhance the data integrity. Key benefits to the industry sector include, as we already mentioned, the compliance. So it enhances the compliance actually by ensuring all production activities are documented and compliant with the requirements that are defined in these master recipes I mentioned as well. MES significantly then reduces the risk of non-compliance.

Secondly, it improves the product quality. This continuous monitoring and real-time quality control help maintain high product quality and consistency. Increased efficiency as well is the third or one of the major benefits of the MES to the industry because actually the automated data collection and control of the manufacturing processes reduce manual errors, streamline operations, and increase overall manufacturing efficiency.

Finally, from the economical standpoint, it allows a faster time to market of the products. Actually, the MES helps reducing the production cycle times, enabling a faster time to market. And one example I pick here is the review-by-exception capability into the MES for Life Science. This review-by-exception capability streamlines batch report reviews to focus only on the exception or in other words, what went wrong during the production, therefore expedite the batch release activity rather than going through tons of papers reviewing every step of the production process. So focusing only on the exceptions.

Jim: Well, yeah, that reducing the production cycle time and getting faster time to market, that makes complete sense given the importance of data and the whole production process. If you don’t have good data, you really don’t have a good production process. So how does MES enhance flexibility and compliance for Life Science manufacturers?

Johan: Yeah. The MES enhances the flexibility through different perspectives. By providing real-time data and analytics, it allows quick adjustments to the production processes as we monitor the processes in real-time and we can then leverage these data to do analytics and adjust those processes. As well by automating the workflows, the MES reduces as well the manual interventions and speeds up the production process. It ensures that the processes are followed consistently, which is crucial for maintaining quality and compliance.

MES also supports multiple production processes. We speak about generic processes that can be adapted with the support of the MES to the different products or to different variations of the product, which makes it easier for manufacturers to adapt to changing needs, whether for new product introduction or process enhancements.

On the compliance side, for instance, in case of a production deviation, MES can immediately alert the stakeholders from quality assurance or from production supervisors, for example, allowing them to investigate and address the issue to reduce the potential impact upfront as soon as the deviation or the exception is captured by the system. This proactive approach not only ensures compliance but also helps maintaining product quality and safety.

Jim: Now we’ve talked a lot about some of the major benefits that MES can deliver, but what are some of the common challenges that companies face when implementing an MES?

Johan: Yeah, and thanks for asking this question. Actually, an MES project is not like a very simple project. It has challenges. And the typical ones that we face or the end users typically face are the high cost of implementation because those are complex projects. They need for process but still technically serve the profile to implement the workflows, the working processes into the system. It’s not only technical profiles, it’s not only process profiles, but a combination of both.

And third, I would say the complexity of integrating the MES with the existing IT and OT ecosystem because actually, while doing this integration, you need to ensure data accuracy and consistency and as well because the integration with legacy systems can be challenging, but this can be addressed somehow by well-planned strategy on the integration and relying on experts in this domain. Overcoming these challenges require actually proper planning involving the stakeholders early in the process and selecting the right MES solution tailored to the company’s need based on the process and the industry sector.

It’s also important to invest in training, training the users, the end users of the solution, mainly the operators and apply change management to ensure that these employees are comfortable with the new system and understand its benefit for them. Finally, working, as I said, with experienced implementation partners help mitigate the risks or those risks and ensure a smooth transition.

Jim: Yeah. So it sounds like it doesn’t come for free. You need, especially because I guess the workflows involved require maybe changing work practices by the people, so that planning, getting those stakeholders involved in the training you mentioned, all are critical. But I guess once you get through the project phase into it running, then you have all that connection and real-time visibility and all the other goodness that MES helps deliver. So what future trends do you see in the MES landscape?

Johan: Yeah. Actually, the MES landscape is evolving. While actually what we call the monolithic MES or the traditional on-premise MES that we use to install at our customers or at the end users infrastructure are still being used and implemented in complex manufacturing facilities into large-scale type of facilities, we see a shift toward cloud-based MES solutions that offer a greater scalability and a better flexibility than these monolithic MES solutions, the traditional ones. There is actually a growing demand for cloud-based light MES solutions that meets the needs of lighter applications. And one of the specifics of those kind of light MES cloud-based solution is that they offer no-code, low-code capability allowing the end users to take part to the implementation and early own their MES solution and easily as well.

The push toward personalized medicine, that’s another topic, which is a new technology in producing drugs and the push into flexible manufacturing processes is driving innovation in MES as MES needs to serve these new requirements. So future trends in the MES area includes as well integration of advanced technologies like AI, artificial intelligence and IoT, Internet of Things. These trends will continue to evolve further for enhancing the capabilities and the benefit of an MES. And just as an example, for instance, AI can help optimize the resource utilization, predict exceptions. I spoke about exceptions and the necessity to capture them as early as possible to deal with them, to avoid rework. So AI can help predicting those exceptions. So avoiding even the exceptions from happening and improve the quality. While on the other side, other example, I mentioned the IoT will allow better connectivity with the floor, with different equipment and real-time monitoring of those equipments and processes.

Jim: Well, that’s an exciting future and you see AI playing a bigger role in a lot of things. So the more it can help spot problems before they’re coming, alert people and provide, I guess, actionable information that just makes the MES become increasingly valuable. So why is it important to integrate MES with the IT and OT systems?

Johan: Yeah. Integrating an MES with the IT information technology systems and OT, that stands for operational technology, ensures seamless data flow and coordination across all levels of manufacturing. The MES system is not a standalone system. It needs to get data from the planning, give back data to the planning and so on.

So on the IT side, the integration with the ERP, commonly named ERP, the Enterprise Resource Planning Systems, ensure consistent flow of production orders from planning to execution in the shop floor, as well as real-time reporting of the material consumptions and what we have produced, ensuring an accurate inventory consolidation at the enterprise planning level, as well as consequently an optimized supply chain. Beyond the ERP, the MES as well typically integrates with other systems from the IT landscape or ecosystem. As an example, I would pick the laboratory information management system, which we integrate with to ensure a quality control is tracked properly, like samples and sample results and so on.

On the other hand, if we look downward or into the automation layer or the OT layer, the integration with the automation enhances the consistency and the visibility. It improves decision-making and optimizes overall production efficiency. Key considerations for this integration include choosing the right integration strategy, and that’s an important decision or debate to have upfront before getting into designing the integration with the automation layer, is to decide on the strategy. Overall, integration helps in breaking down the silos and enables better collaboration between different departments. There is another aspect as well that I wanted to mention here, is the security, because as soon as you start integrating your MES with the other systems, you expose vulnerabilities. So it is a critical aspect of this integration to consider the security or the cybersecurity.

Jim: Yeah, that OT/IT integration and getting not just between systems, between different organizations within a company collaborating, and that’s a really important point on the cybersecurity. Once you’ve got that integration, you’ve got to pay really close attention to the cybersecurity of it. I guess, how does MES support the digital plant maturity model or DPMM in the Life Sciences industry?

Johan: Well, MES plays a key role in digitizing manufacturing processes, particularly the Life Science industry. So the DPMM, or what we call then the DPMM or the Digital Plant Maturity Model, has been developed by the BioPhorum community to help companies or end users assessing the digital maturity of their plants. As plants aim to move up in the maturity model, actually this DPMM has five levels of maturity, so as plants aim to move up in this maturity model, the MES can help them achieve this higher level of automation. Because moving up into the maturity, the digital maturity, means leveraging advanced analytics, predictive maintenance, continuous improvement practices, and to do so, you need the MES that will provide the foundation for these initiatives by supporting a transition toward smarter and more efficient and responsive manufacturing operations. To describe it further, I would say MES supports the DPMM by providing real-time data, enhancing process control, and enabling continuous improvement.

Jim: It sounds like it’s a key component in moving up the maturity model, getting higher to that fourth and fifth levels in there. Well, this has been a really great discussion, Johan. So where can our listeners go to learn more about Emerson’s solutions for MES?

Johan: Well, typically on our website, we have a dedicated section for Life Science, MES solutions, and all the portfolio of software solutions we offer to help our end users in the industry achieving their digital maturity.

Jim: Well, that’s great. Well, and I’ll add some hyperlinks to the area, that Life Sciences and Medical section, as well as the specific DeltaV MES section for our listeners to learn more about our solution. So thank you so much for joining us today, Johan.

Johan: Thank you. Thank you for having me. It was really great to discuss this topic with you.

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