How to speed up pharma MES projects while operating at full capacity
Digital transformation is key in order to keep up with competitors in the future.
What’s unique for pharmaceutical companies: they must adopt new technology while ensuring regulatory compliance in an environment burdened by paperwork – literally.
This is where the manufacturing execution system (MES) comes into the picture.
An MES implementation is a daunting task for companies that are already running a fully loaded life sciences operation. Fortunately, the process can be shortened by utilizing NNIT's Accelerated Implementation Methodology, which draws on well-established industry standards.
Pharma manufacturing sites that have been operational for many years tend to consider MES projects to be unpredictable and disruptive. Despite the many benefits of having an MES system for manufacturing, the intense requirements in terms of time, capital and manpower make managers reluctant to give the green light. Thus, to minimize the impact on daily operations, it is essential that MES implementation is carried out as swiftly as possible.
"The Accelerated Implementation Methodology is a game-changer for pharmaceutical clients. It makes it so much easier to implement a business-process-altering system while running a fully loaded operation."
says Ming Chua, Managing Director of NNIT in Singapore.
Use a proven methodology
The most efficient approach to a pharma MES implementation is to use a methodology based upon widely accepted industry standards. Such is the case with NNIT's Accelerated Implementation Methodology, which draws upon well-established industry models like MESA, ISA-95 and TOGAF.
These models provide the framework you need to design your IT/OT architecture and structure your MES implementation process. And there is rarely a need to customize or create your own approach – a standardized approach will significantly enhance the speed of integration of all systems for the vast majority of manufacturing sites.
Secure early stakeholder engagement
To achieve successful MES implementation, it is essential to engage key stakeholders as early as possible. This includes all teams that are directly involved, like operations, IT, and production, as well as senior management, such as the head of manufacturing and head of quality. Executive sponsorship is critical to ensure access to the required funding and resources.
Some of the main MES implementation pain points are the disruption of day-to-day operations and the need for key staff, such as production specialists and process area experts, to be heavily involved. If the long-term benefits, based on clearly identified business drivers, are not visible and universally understood and accepted, there is a significant risk of friction within the organization and that will most likely result in project delays and operational issues. A clear, lean governance structure is the key to making correct decisions fast.
Be rigid with your project methodology
Once you have selected your project methodology, it is important to ensure strict adherence to it throughout the project. The potential benefits can only be realized if all stakeholders agree to rigidly follow the standards and procedures.
"The experience of multiple MES implementation projects has demonstrated to us at NNIT that, when it comes to accelerating your MES projects, the importance of applying a well-established project methodology, and using a project team whose members have been properly trained in that methodology, cannot be overstated," says Ming Chua.
Only by applying accelerators and an unyielding adherence to the methodology does it become possible to achieve a significant reduction in project time, effort, cost, and risk. And the impact on your organization is far less than it would have been with a more conventional implementation process. Various MES implementation projects that have been executed following such an Accelerated Implementation Methodology have demonstrated that the implementation cost can be reduced significantly.
Furthermore, MES systems in pharmaceutical production can be implemented in half the time required for a non-accelerated approach. The savings in terms of time and cost are even more noticeable when applying such a method to a multi-site MES implementation program.
Do you want to know more? You can check out our white paper: How to speed up MES projects – to save time and reduce costs The white paper delves into the how and why of the accelerated MES implementation method – and it demonstrates that an MES implementation does not have to be as complicated, costly or time-consuming as you might think.