By Lynette Nazabal, Clarkston Consulting
Have you made a strategic business decision to implement a manufacturing execution system (MES) as part of your enterprise landscape and to complement your digital supply chain? If so, you might be thinking, “How do I execute an MES vendor selection that will provide the most visibility into the capabilities of all the technologies within the market?” or “How do I select a software partner that will support my business needs as they grow and evolve?”
Look no further! Selecting a MES vendor is a strategic and thoughtful process, and it can be beneficial to the needs of your company if you take the care up front to understand how MES fits into your enterprise landscape and establish your business requirements. In this article, I outline five key considerations for an MES vendor selection.
1. Understand How MES Fits Within the Digital Supply Chain
A digital supply chain can be complex and requires careful planning to ensure that the path for data integration is robust and compliant. Many systems can play a part in this sequence of capturing manufacturing data from start to finish, and MES is a key component to capture real-time inventory adjustments in the warehouse, equipment status, and manufacturing execution steps. Understanding what data MES will receive and distribute to other systems is essential to define business requirements for your vendor selection phase. Having a digital supply chain roadmap that is inclusive of all enterprise and manufacturing systems will aid in identifying the role MES will play and the data flow between systems. It also will help you determine the right time and phasing of your MES implementation as key data elements from certain systems (e.g., ERP) will allow for a much more unified and streamlined integration.
2. Establish Business Requirements
Understanding the business requirements for MES will help you make the most of your vendor selection. Laying the functionality and the offerings of each software vendor over the business needs of your organization can help determine the right MES for your company. Business requirements should not only reflect the present need, but they should also include the needs for your organization long-term. For instance, you may not intend to interface with a LIMS system in the first phase, but you want to ensure it has the capability to do so when the time is right. How the software connects to other supporting systems, as well as network capabilities, should also be a key factor. In addition, ensure the software meets all Part 11/Annex 11 Compliance requirements as well as provides dedicated system administrator privileges. In summary, before starting an MES vendor selection, make sure that the defined business requirements are comprehensive and provide expansive functionality that can be implemented to complement your business processes.
3. Keep Support in Mind
The journey to achieve an optimal MES implementation can be lengthy and may take several phases depending on scope. As your implementation roadmap continues, the need for system support for the current state as well as future phases is important. System stability, performance, and security must be maintained as you implement new functionality and as the end user population expands. In addition, a strong support model must match your production activities in the event of a critical issue. It’s key to find a software vendor that provides the level of support for your system and for your needs as part of the overall software package. Often, post go-live support and operational support fall short once a project is completed, as many life sciences companies don’t usually have internal teams in place to support these types of applications. MES software support is a critical part of implementation and should be evaluated during the Request for Proposal (RFP) process.
4. Develop Strong RFP Guidance and Evaluation
A Request for Proposal (RFP) should be a lot like shopping for a new house or a new car. You should understand your needs and business requirements prior to executing a vendor selection. Organizations should also understand how MES is going to sit within the enterprise landscape and what infrastructure capabilities will be needed to support system implementation. Providing detailed information and solid RFP documentation to the vendors to be evaluated can quickly determine what solutions may fit your business needs versus others that do not have certain capabilities.
While many vendors can claim to do just about anything, it’s important for the vendors to define whether they can provide most of your business requirements with out-of-the-box functionality versus a customized solution. The more customization, the more costly a solution can become. Taking the time to be thoughtful and organized with an RFP can provide clear line-of-sight to the best MES solutions for your organization. In addition, many MES vendors are the main source of implementation and support resources. MES vendor professional services organizations are a critical dimension of the RFP that need to be included and evaluated. As you move forward with a MES vendor selection, consider the need and the cost to build capabilities internally or outsource to additional third parties, as well as if you should buy integration services from the vendor.
5. Ask for Relevant Business Cases and References
In the current landscape of technology providers, understanding a vendor’s capabilities and service offerings is not the only way to determine if a vendor is right for you. Demonstration of good customer relationships as well as relevant business cases to support their expertise should be an area of evaluation included in the vendor selection. An established MES provider should be able to supply equitable references to match your business, implementation approach, and manufacturing processes. In addition, relevant business cases will quickly establish whether a vendor has the expertise to understand your business processes and can support you as a long-term partner.
Selecting the Right MES for Today and Tomorrow
Taking the time to pick the right MES software can be a complex process, but the benefits of selecting the right MES and the right partner can accelerate the return on investment and provide operational efficiencies quickly to any organization. As the global MES market continues to grow — with a projection to reach $24.16 billion by 2030 — now is the time for your organization to start thinking about how to maximize your investment.
This article was originally published on Clarkston Consulting’s website. Republished with permission.
About The Author:
Lynette Nazabal is a client solutions executive with Clarkston Consulting and serves as the firm’s pharmaceutical, biotech, and contract manufacturing and research organization lead. She has worked within the pharmaceutical and biotech industry for almost 18 years, with differentiated experience that includes quality systems, laboratory operations and technology, validation, and regulatory operations and compliance. Nazabal also has considerable expertise in manufacturing execution systems, with a specific focus on batch record design, master data management, business process flow, training, and project management.