6 Common Myths About Adopting a Manufacturing Execution System (MES)

Implementing a complete MES into an existing pharmaceutical or medical technology manufacturing environment can take months, or more likely years, depending on complexity. The implementation often poses technical and nontechnical challenges that are difficult and time-consuming to overcome, including balancing the needs of stakeholders across the organization.

For a traditional MES, it can take between one and two years to complete an internal requirements gathering, budgeting, and selection process, followed by another year or two of actual MES implementation, again depending on complexity. ² In addition, custom-built MES configurations based on MES tool kits can run a license-to-service-dollars ratio upwards of 1:5, meaning that for every $10,000 spent on licenses, manufacturers may actually spend $50,000 in services. A commercial off-the-shelf MES solution can be in the range of 1:2. ³

While these challenges have historically existed for traditional MES, the reality is that a modern MES like MasterControl Manufacturing Excellence can be implemented quickly and affordably, from planning and discovery through building, testing, and training to go-live. MasterControl’s modern, cloud-based software-as- a-service (SaaS) solution is typically implemented in under six months – without upfront hardware costs or a huge team of IT and external consultants draining resources. MasterControl’s license-to-services ratio of 3:1 is dramatically better than a custom-built MES configuration or a commercial off-the-shelf configuration of MES software.

With flexible pricing plans, the MasterControl solution is more cost-effective than traditional MES software. It is license-based, so it is affordable for any sized operation and can scale as the organization grows, with seamless upgrades to meet increased demand.

Traditional MES are typically rigid systems because they were built for a specific set of requirements and with narrow architectures. Adopting a custom-built MES can be very expensive and extremely slow to implement, and while a traditional off-the-shelf MES can be customized, almost everything is hard-coded.

Rigid, hard-coded process configurations make legacy MES difficult to adapt when processes, products, product parameters, or volumes must change. Making changes is time-intensive and involves costly process re-engineering. In fact, many companies will reprocess to make sure they are getting it right the first time, which further extends the implementation timeframe.

Where traditional, hard-coded MES often require a company’s people and processes to adapt to the system’s workflows and capabilities, the new class of purpose-built MES easily supports existing processes and workflows, so there isn’t costly process re-engineering.

MasterControl provides no-code configuration that allows organizations to configure quickly to adapt processes and parameters for changes to their product and how the product is manufactured. A highly configurable no-code master record builder and product family tool give manufacturers the flexibility to quickly design, modify, approve, and templatize master production records, as well as easily manage product recipes, variants, substitutions, and change control. With MasterControl’s flexible, cloud-based manufacturing solution, there is no need for a computer programmer to design a system from the ground up and come in every time a change needs to be made.

People are naturally resistant to change, especially when it disrupts an existing process. That alone often makes it challenging to get employee buy-in on a new system, and when you couple that with a complex MES, the barrier to acceptance is even greater. When that system isn’t necessarily user-friendly, adoption and use can be even more challenging.

One of the things inherent in the design of software systems like traditional MES is that the software is set up to highly automate, often at the expense of the user. Its machine-centric design creates a poor user experience (UX), and it often requires highly educated and highly skilled employees to use it. Not only is it difficult to use by the end user, but it often requires dedicated internal and/or external support. In reality, a modern MES like the user-friendly Manufacturing Excellence solution can be fast to adopt without the need for dedicated support.

In reality, a modern MES like the user-friendly Manufacturing Excellence solution can be fast to adopt without the need for dedicated support.

MasterControl’s simplified MES is user-friendly and designed for any manufacturing environment, easily mapping to and supporting existing processes and workflows. The solution’s pick-up-and-use simplicity is focused on the operator and their ability to quickly adopt the software without the need for ongoing support resources. It is configured to resemble the manufacturer’s current paper production record, but with a user interface (UI) and UX designed specifically for mobile technology such as tablets on the shop floor, so it is familiar to the worker and easier to adopt.

Further contributing to rapid user adoption is the user’s ability to quickly and easily build out and use a variety of production record templates – with a global elements library for efficient scaling and integrated product family tool to simplify recipe and product variant management – requiring minimal training, without having to engage a third party or needing a technical background.

Most MES implementations have a stall point where the system is rolled out onto certain lines or at certain sites, and cost justification becomes a major challenge. The cost of a traditional MES is so high that it is often justified only on a certain number of high-volume or high-margin product lines. That means the MES is rarely deployed across all product lines and sites due to cost and/or fit.

Whether an organization needs to scale up to increase production capacity or to scale down to mix smaller batches, life sciences manufacturers must be nimble and adaptable. A lot of traditional MES can be highly effective for certain aspects in certain lines, but the promise of scaling across the entire manufacturing environment remains mostly unfulfilled today – mostly.

Once implemented, a flexible, cloud-based application like MasterControl’s is cost-effective enough to eliminate paper-based processes for all production lines – including those that typically remain paper-based even after a manufacturer purchases and deploys an MES. Manufacturing Excellence can quickly scale up and out across production lines and sites to meet the demand of changing environments and markets.

As the life sciences manufacturing industry has changed and moved toward personalized medicine and cell and gene therapy, the technology has changed as well. Manufacturing Excellence is ideal for lines that a traditional MES has difficulty serving: high-mix, high-variability, low-volume, or batch-of-one lines. Flexibility and simplicity in building master templates and the ability to adjust for different product recipes or variations further makes MasterControl’s modern MES beneficial for contract manufacturers and manufacturers of highly customized products or personalized therapies.

Validation, which typically gets rolled up into implementation costs, is another common barrier to investing in manufacturing software. Traditional MES tend to be so highly configured, tailored, even customized, it can make the validation process very difficult to complete. Anytime there is an upgrade or a change that needs to be introduced, software validation becomes much more difficult.

When dealing with highly tailored MES, change control requires a lot of resources and extensive time to make approved changes. Manufacturers may also become reticent to take advantage of new functionality the software vendor may be offering because of the validation cost. Before they know it, the manufacturer may be sitting on software that is five, 10, 15, even 20 years old – and the changes that will need to be validated have accumulated.

Contrary to the longstanding view of software validation as a burden, validation can be relatively simple. A modern MES like Manufacturing Excellence employs a risk-based, automated approach to validation that focuses on a manufacturer’s critical business processes. Its proven process leverages the software provider’s internal validation testing to reduce overall effort, cost, and time – reducing the overall system validation time from months to days, if not hours.

For change control, MasterControl utilizes advanced patented technology to present the changes needed to be reviewed. This limits the risk and cost to upgrade, allowing for simpler, more frequent upgrades as well as sustainable validation in the cloud.

A traditional MES is a significant investment, with the upfront cost being only one of many expenses associated with adopting the new system. Configuration, implementation, and licensing must also be factored in, along with the long-term costs of training, maintenance, and validation. The total price tag often starts at $1 million to $2 million, even exceeding that range, depending on the scale and complexity of the manufacturing environment.

The combined price tag plus slow time to value can put traditional MES solutions out of reach for many manufacturers, particularly small and midsized manufacturers.

Implementation of a modern solution like Manufacturing Excellence is fast, and once implemented, the system can deliver results quickly. MasterControl customers typically see initial return on investment (ROI) within four to eight months, depending on the number of operators, driven by labor efficiency, error reduction, and accelerated good manufacturing practice (GMP) review.

Initial payback is only the start of the value achieved with MasterControl’s modern MES solution. Error proofing, automated controls, in-line quality, work-in-progress (WIP) visibility, and review-by-exception contribute to dramatic, sustainable process and operational improvements that drive long-term value, including: 25% fewer deviations, 90% fewer data errors, 30% greater efficiency, 80% faster GMP review, and 50% faster product release. ⁷