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?  

Whether you’re responsible for manufacturing for an established global pharmaceutical company with an entire plant network or in charge of quality excellence for a new biotech just starting up its first production run, it’s time to think about your Manufacturing Execution System (MES).

If you’ve been in the industry for a while, you’ve probably seen just about every variation of MES under the sun – most implemented around the turn of the century. However, MES solutions have matured since then to dynamic platforms that can help drive operational efficiencies and competitive advantages 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 sciences companies are making the investment that will bring manufacturing data to the same level of usability as their ERP, Lab, and Quality Management Systems. This enables better analytics, identifies process improvements, and defines key performance indicators for the shop floor to drive results.

So, where should companies 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 process and 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 allow a more detailed understanding of the intricacies of the entire production process before the first commercial batch.

This also eliminates most of the headache that comes with digitizing manufacturing, including pain points often encountered when transitioning from a paper-based batch record execution to an electronic execution. This will ensure a strong foundation for operational efficiency and continuous improvement while meeting the expectations of today’s regulatory authorities.

MES Solutions for Life Sciences 

There are several MES solutions that have made advanced improvements for the life sciences sector as well as delivering a more agile platform with cloud solution offerings. Many 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.

Tools for Increased Visibility & Quality Control  

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 deviations prior to final release. However, not all MES solutions are the 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 whether the MES solution delivers more life sciences-centric functionality and can meet those manufacturing complexities and regulatory compliance without having to highly customize the solution.

AI-Enabled Capabilities  

AI is continuing to enable new MES solutions for life sciences companies, becoming more of an important piece of the modern MES landscape. Vendors are continuously introducing new AI-powered capabilities such as intelligent operator assistance, predictive quality, anomaly detection, batch record development, and manufacturing analytics. Moving forward, life sciences companies should evaluate approaches to governance, validation, data integrity, and human oversight, on top of constructing an AI roadmap, staying ahead of the curve of continued AI innovation.

Cloud-Native Architecture  

As the industry shifts from on-premise solutions toward cloud-based MES solutions, companies need to change the way they evaluate potential vendors. These cloud solutions are becoming increasingly powerful as manufacturers seek greater scalability, faster deployment, connectivity across sites, and ease in upgrading and support. For companies considering these solutions, first they must evaluate cybersecurity, system availability, integration architecture, and data residency. Additionally, companies need to take a focused look at disaster recovery, including system redundancy, backup and failover capabilities, and recovery time/recovery point (RTO/RPO) requirements to minimize potential disruption impacts.

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 the optimized end-to-end digital process is that you want MES to support. 

MES can provide real benefits early in the digital transformation journey when paired 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. 

Contributions from Spencer Simco