In this series of blog posts, Lynette Nazabal, Client Solutions Executive, explores the strategic decisions you need to make when thinking about your Manufacturing Execution System (MES), the changing landscape of MES technologies, the questions you should ask, and how you should approach your MES implementation to maximize your investment decision. It’s time to think about your MES … Are you ready?  

If you’re responsible for manufacturing and quality excellence for an established global pharmaceutical company with an entire plant network or a new biotech just putting up its first pilot, it’s time to think about your Manufacturing Execution System (MES)!   

If you’ve been in the industry a while, you’ve probably seen just about every flavor of MES under the sun – most of them implemented when power suits, acid-washed jeans, and the DeLorean were still in style. However, MES solutions have matured from that necessary evil used for weigh and dispense to a dynamic platform that can help drive step-changing efficiencies and competitive advantage well beyond the shop floor.  

Getting Started with Manufacturing Execution System (MES)  

With a growing number of pre-commercial life sciences companies beginning their digital transformation journey at earlier stages, digital strategies and roadmaps are being defined as the walls are built on brand-new state-of-the-art manufacturing sites. At the heart of these strategies – which are allowing more companies to reap the benefits of a seamless, digital supply chain – is the need to implement an MES. More life science companies are making the investment that will bring manufacturing data to the same level of usability as their ERP, Lab, and Quality Management Systems.  They’re doing this to enable better analytics, identify process improvements, and define key performance indicators for the shop floor in order to drive results.

Where to start? By implementing MES at earlier stages, or replacing what you have today, many companies can now digitize manufacturing processes at the very beginning and analyze indications of quality control issues on a more focused scale. Pre-commercial companies can use MES during initial engineering runs to train operators, stress test the full manufacturing process, and understand in greater detail the intricacies of the entire supply chain before the first commercial batch. This also eliminates most of the headache that comes with transitioning from a paper-based batch record execution to an electronic execution – something that you will absolutely want to do for efficiency and to meet the expectations of today’s regulators.      

MES Solutions for Life Sciences 

There are several MES solutions that have made advanced improvements for the life sciences sector as well as delivered a more agile platform with cloud solution offerings. Most of them are touting “out-of-the-box” integrations with ERP, SCADA, Data Historians, QMS, and LIMS via the use of standard connectors or their own integration suite as add-ons to the main product. Meaningful advances in the operator interface have also been made by delivering guided execution and low-code batch record configuration. These have made solutions more user-friendly and eased implementation challenges. 

The concept of “Review by Exception” and enhanced quality controls have become standard functionality to ensure an almost complete reduction of operator error on top of increased visibility to execution issues or trends prior to final release. However, not all MES solutions are a right fit for the life sciences sector. While there are business cases for most to try to fit, the growing complexity of manufacturing processes, such as cell and gene therapy, can make certain MES solutions more difficult and costly to implement. It’s important to understand if the MES solution delivers a more life sciences- centric functionality and can meet those manufacturing complexities without having to highly customize the solution. 

What Next?

Before any life sciences company begins an MES vendor selection process, it must first establish the role that MES plays in the landscape of the digital supply chain. It’s important to define the data flow, key integrations that provide a return on investment, and ultimately what is the optimized end-to-end digital process that you want MES to support. MES can provide real benefits early in the digital transformation journey with the right solution, the right implementation, and the right roadmap to success. If you’re looking for guidance on your digital transformation journey, Clarkston can help.