Clarkston’s life sciences and MES expert Lynette Nazabal recently attended the 2023 Pharma MES Conference in San Diego, California. The two-day event brought together over 200 Manufacturing Execution Systems (MES) and manufacturing experts to discuss MES with a focus on digital transformation, Pharma 4.0, and manufacturing execution.  

At Pharma MES 2023, the MES user community from pharma and biotech companies presented some key insights into challenges faced when implementing and optimizing MES, with topics ranging from MES integrations, electronic batch record (EBR) design, computer system validation (CSV), and data and analytics. Several MES vendors also provided updates on some of the key trends and roadmaps for different MES solutions.

With a recurring theme of “How does MES fit into the digital transformation journey, and what are the benefits?”, workshops and roundtable discussion topics focused on data integrity, flow and strategy, multi-site implementation, and integration optimization. Below, we outline some of my takeaways from Pharma MES 2023.

Key Takeaways from Pharma MES 2023 

1. Strong Business Requirements Drive Implementation Success 
   Developing strong business requirements is a key element of an MES vendor selection process and implementation strategy. Challenges faced with implementing an MES can often be traced back to not defining the right requirements or not understanding what the business needs are for an MES.  Oftentimes, companies leverage the vendor for assistance with developing requirements that can be generic or representative of another company and modality.  Understanding the business requirements for your MES and how it sits in the enterprise landscape of your digital supply chain will help drive the success from the start of your implementation and align the entire organization to a common goal for MES. In addition, leveraging key manufacturing end users with hands-on knowledge of the shop floor can provide valuable insights for the development of business requirements and better business adoption.
2. Building a Connected Manufacturing Network is becoming more Complex 
   As pharma and biotech companies look to increase the digital maturity of plants on a local and global level with a focus on integration and real-time data visibility, the need for more sophisticated connected networks for manufacturing is driving complex architecture designs that are no longer simple and linear. MES leads are now faced with the challenges of having to integrate multiple systems to support a digital supply chain that includes not only ERP and SCADA but may also include other manufacturing systems, LIMS, QMS, CMMS, and Data Historian. This is amplified by the need for cloud-based solutions (sometimes SaaS models) to integrate with on-premise automation solutions that may also be different across multiple plants. As a result, manufacturing is having to lean more on their IT partners for assistance to implement complex connected networks and is leveraging integration tools such as Boomi and Mulesoft to remain agile and flexible. The “Factory of the Future” can be a reality, but it takes innovation, creativity, and strategic partnerships with IT.
3. Taking a CSA Approach to Validation 
   With the FDA emphasizing Computer Systems Assurance (CSA) that follows a more risked-based approach to computer system validation (CSV), the discussion around how to validate MES is shifting in a direction that could help streamline implementation and reduce unnecessary documentation. MES leads and Quality Assurance (QA) are beginning to look at focusing on the critical aspects of MES and how to validate in order to reduce significant burden for implementation and operational maintenance. While there are still challenges in how to approach risk-based CSA and meet QA partner expectations within the organization, the appetite to implement a more streamlined approach is on the minds of MES leads as well as the utilization of tools such as electronic validation systems to further increase efficiency.
4. Pick the Right Partner 
   MES implementations can have a multitude of challenges – inadequate business requirements, struggles with appropriate scope and phasing, complex integrations that can cause severe resource constraints, and the extension of timelines – and become quite costly for an organization. At Pharma MES, MES leads repeatedly described the need for a strong, knowledgeable system integrator that can support not only the MES strategy and implementation but can understand their digital transformation journey and the complexities that come with it. MES leads require partners that will support the holistic project that not only includes stand-up of the environment and its configuration but also the vendor architecture design, business requirement development, vendor selection, validation, and change management – all key components for a complete and successful MES implementation. Many of the software vendors will focus specifically on the technology implementation.  A good partner will help you implement MES; a great partner will help you achieve the maximum benefits and return on investment and regulatory compliance while providing a complete solution for your manufacturing organization.

Pharma MES and Beyond 
This year’s Pharma MES conference was a great opportunity to hear from MES leads in the user community who are driving innovation and sharing their approach to ongoing challenges as well as where they are in the digital transformation journey. Attendees also had the opportunity to view demonstrations of some of the new features and capabilities that MES vendors have to offer to pharma and biotech companies, with some emerging leaders making significant investments in cloud-based solutions and seamless integration offerings.

As the industry becomes more advanced with automation and the concept of “manufacturing excellence,” coupled with the increasing need for optimization and real-time data visibility, the MES user community is looking for solutions and strategic partners that can lead them through a successful MES implementation and help them navigate their digital transformation journey.

Reach out to Clarkston to learn more about our MES consulting services today.