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In the fast-evolving life sciences industry, there is an increasing demand for cost-effectively launching drug products at speed, using sustainable manufacturing methods. Successfully navigating manufacturing practices to reach these objectives is a difficult task, and so companies across life sciences are harnessing digitalisation, turning to technologies like manufacturing execution systems (MES) to help them get there.
With MES in place, manufacturing practices can be seamlessly tracked and documented across production lines, allowing for better operational efficiency and access to data insights in real time. Traditional paper-based methods are no longer required, with data collected, stored and processed on computerised systems, helping to reduce production waste.
However, in this highly regulated industry, companies have been slow to introduce this level of digitalisation. Also, as technology continues to advance, these systems must be continuously updated and revised to ensure best practices are maintained, which is an additional hurdle.
Here, Olivia Gannon Associate Director of Global MES & Digital Execution Systems in Life Sciences Manufacturing at Cognizant, explores the importance of an effective digitalisation strategy in the life sciences industry, the drivers for digitalisation and current challenges slowing its uptake.
Harnessing MES to Meet Manufacturing Objectives
The life sciences industry must overcome challenges to meet growing demands, and embracing technological advances, such as MES, can help enhance productivity. As a result, the industry is moving toward digitised systems to reach manufacturing objectives, including:
Meeting fast delivery times: MES provides increased efficiency, accuracy and data accessibility across manufacturing lines, and streamlines production. Real-time monitoring gives companies better operational control whilst mitigating the risk of errors or deviations. It also enables informed decision-making and process optimisation to accelerate delivery.
- Making production cost-efficient: Lean manufacturing principles help manufacturers reset their materials cost base. This enables them to improve product yield, capacity, cycle and batch release times by avoiding capital spend and inventory reductions.
- Transforming to sustainable practices: In line with the 2015 Paris Agreement, the industry must become more sustainable, working to reduce carbon emissions across the entire value chain. Introducing digital systems helps streamline processes, helping companies across the supply chain reduce Scope 3 emissions by reducing carbon, energy, water and solvent consumption.
- Adhering to regulations: The move away from traditional paper-based records and processes (such as batch records, standard operating procedures, logbooks, controlled forms, etc.) to electronic alternatives allows for better data accuracy, visibility and analysis across processing lines. These comprehensive digital data and process records, which are generated and stored using MES-related technologies, help to ensure compliance with FDA and EMA regulations in line with good manufacturing practices (GMP). Electronic documentation systems must be validated before use.
With the seamless integration of digitalisation into manufacturing, essential treatments can be brought to market — and patients — efficiently.
Overcoming Aversion to Embracing MES
Despite the benefits of digitalisation, life science companies can be slow to adopt new systems, due to any potential changes to manufacturing practices needing re-validation in line with GMP. However, remaining reliant on paper-based records and processes can hinder transparency across production lines and departments, leading to siloed ways of working and limiting value gained from data insights.
This reluctance can stem from a lack of understanding of data and its capabilities, unfavourable perceptions, or doubt of the value of digitalised systems from previous instances and the preemptive disruption to established workflows. Although the transformation to paperless can be a daunting and seemingly lengthy process, embracing these advanced systems can provide substantial value to manufacturing lines.
Overcoming these limitations requires a mindset shift, helping companies bridge the gap between paper-based processes and digitalisation capabilities to realise the full potential of an evolving MES landscape.
Integration of Digital-First MES
Recent shifts toward digital execution solutions have started to change perceptions of MES, leading to its digital-first evolution, and working towards a comprehensive digitalisation strategy.
As part of this transformation to paperless solutions, many organisations are using disruptive technologies. These low-code and no-code opportunities offer human-centric transformation, streamlined and user-friendly interfaces, circumventing the need for extensive programming knowledge. This means applications can be easily configured and developed, allowing departments outside of IT to take more ownership and harness their potential for use in processes involving unique, individualised and small-batch production runs.
An effective digitalisation strategy enables better-informed decision-making and data-driven solutions through greater accessibility, agility and openness to critical information. These solutions empower businesses to navigate their processes with greater efficiency. To achieve the full potential of a digitalisation strategy, the following points should be adopted:
- A flexible approach: Introducing a customisable digital solution allows companies to adapt the strategy to their unique needs. By introducing MES iteratively, a modular and flexible strategy can be built for seamless integration into current operations.
- A robust data management strategy: Having a strategy in place that uses a contextualised data model provides effective data management and analysis for relevant data-driven insights.
- A mindset for continuous improvement: When introducing MES solutions, a proactive approach is essential to ensure that solutions evolve with advancements in digitalisation to attain their full potential.
- A comprehensive validation plan: Making sure that evolving MES systems meet computer software assurance guidelines helps to streamline process validation in line with regulatory standards.
Looking Ahead at MES in Life Sciences
Although the life sciences may at times have been reluctant to introduce MES, the number of companies incorporating digital systems into current operations is growing. As digitised technologies continue to advance, MES will evolve and further shape manufacturing processes. Meanwhile, the integration of Internet of Things (IoT) devices with MES will only further increase data visibility and accessibility. By introducing a flexible digitalisation strategy, companies can harness interconnectivity to streamline manufacturing processes, implement more collaborative working practices and meet manufacturing objectives.