Continuous growth, increased diversity of pharmaceutical products, and emergence of novel therapeutics, such as cell and gene therapies, require pharmaceutical companies to embrace digitalization.
All industries are undergoing digital transformation, and pharma is no exception. What's unique for pharmaceutical companies is that they must innovate and adopt new technology while ensuring regulatory compliance in an environment burdened by paper.
Digitalization is key to managing one of the most important production assets: information. When systems of increasing complexity need to be managed, it is essential to have all your data and information in one place - which ensures that medicine can be produced. One key element of digital architecture is the manufacturing execution system (MES), which provides and collects all the required information in real time and eventually removes all paper from the production process.
According to global research and advisory firm Gartner: The MES market originally focused on production operations, data collection, procedural enforcement, and manufacturing optimization. It is now a key to digital business for manufacturers.
"We see a disruption within pharma production" says Thomas Halfmann, Global Head of Production IT, Life Sciences, at NNIT, who has worked with pharma production IT for more than 20 years. He continues:
"The traditional production model is changing forever. Products and therapies are becoming increasingly specialized, requiring high flexibility and agility in manufacturing and supply chain. Information technology that is available to us today is not only supporting those novel production modalities but enabling them. Managing all this on paper is not an option."
MES orchestrates it all
The most essential component of digital production is the MES. It is the platform for collecting and managing all relevant production data in real time - from ERP, LIMS, process control systems, machines and equipment, operators, and many other sources. It is the MES that ties all these different elements of production information together.
"The concept of MES as a system to execute, monitor, track and report manufacturing operations has been established in the pharmaceutical industry for more than 20 years. However, today MES solutions have to cope with increasing complexity while meeting the needs of digitalization and Pharma 4.0" explains Thomas Halfmann.
- "In order to manage such complex information and ensure more flexible production, the MES acts as the hub for production IT. It orchestrates all the info needed, from planning and execution to the batch reports necessary to release the finished product." says Thomas Halfmann.
Despite that the business case for MES is widely accepted, many pharma companies struggle with the implementation of MES. According to an NNIT survey, as many as 30 percent of companies in the pharma industry have not implemented an MES. There are several reasons for this, as Thomas Halfmann explains:
- "People get the implementation blues before even starting. An MES is a multi-million-dollar investment and implementation involves months of planning, systems integration, testing, and validation. Our data shows that the standard implementation time for an MES ranges from 18-24 months. Since an MES project has a significant impact on production, that is long enough for many heads of production to have serious reservations."
On top of that, MES implementations present additional risks:
- "I have seen companies selecting the wrong solution, implementing an unsuitable scope (too much or not enough) and budget overruns due to excessive customization. Also, an incapable implementation partner or poor organizational change management can jeopardize the success of an MES project" says Thomas Halfmann.
Huge organizational impact
MES projects always require deep involvement by stakeholders from all areas of production. This takes time away from day-to-day business operations.
- "Implementing an MES usually requires key staff, such as production specialists and process area experts, to be heavily involved. These individuals are usually extremely busy and tying them up in the implementation will act as a bottleneck for both daily operations and other projects" says Thomas Halfmann.
 Rick Franzosa, Magic Quadrant for Manufacturing Execution Systems (Gartner Inc.: November 2018)
Imagine implementing an MES in half the time
NNIT developed the Accelerated Implementation Methodology to streamline the process of implementing or upgrading an MES in a pharma organization, reducing the cost, time and risk involved.