Olivia Gannon, Associate Director of Global MES and Digital Execution Systems, Life Sciences Manufacturing, Cognizant, explores how a digitalization strategy harnessing the latest innovations in MES technologies, can help streamline life science manufacturing.
In recent years, a number of business drivers have been shaping and revolutionizing the pharmaceutical manufacturing space. The first driver being the reconciliation of quality and speed to market, with it becoming increasingly important to deliver high-quality treatments more reliably and faster than ever before. The second business driver we have witnessed taking center stage is sustainability, with the industry putting greater focus on minimizing Scope 3 emissions across the supply chain. Finally, as the third driver, companies are focused on minimizing capital spend and adopting lean manufacturing principles to streamline costs and optimize product yield, capacity, cycle and batch release times.
Data-driven decision-making plays a major role in enabling the success of these business drivers. Optimizations can be realized faster, by using a unified platform approach and a “connected by intent” mindset to allow seamless data interconnectivity to provide valuable insights in real-time from across operations to deliver improvements.
Manufacturing execution systems (MES) — computerized systems used to track and document manufacturing processes — are at the heart of many companies’ strategies to achieve this interconnectivity and improve decision-making. As this technology has evolved, so have the possibilities, with cloud-based and automation tools helping to simplify operations across the manufacturing chain and provide new opportunities and value. All of this has implications for companies’ future digitalization strategies.
MES technology enhances operational efficiency and data integrity, enabling companies to use real-time insights to meet goals. In addition, it ensures strict compliance with FDA and EMA regulations in line with good manufacturing practices (GMP). These guidelines require documentation to be available for inspection purposes — provided the MES technology has been validated, the guidance permits it to be used to store this documentation securely and compliantly1.
The benefits of digital-first MES technology
While MES technology has long featured in large pharmaceutical companies’ digitalization strategies, many manufacturers remain heavily reliant on paper records and paper-based processes for data insights. Using batch records and standard operating procedures (SOPs), logbooks, controlled forms, shift registers and more, many companies are operating with disparate documentation that can be challenging to track across departments.
Transitioning to truly paperless processes can be complex, historically taking up to two years to complete2. Some companies are reluctant to make the shift, daunted by the potential disruption and uncertainty about the value of such a change.
In recent years, the pharmaceutical industry has changed its approach to the adoption of digital execution solutions, transforming the perception of MES and bringing about a “digital-first” evolution. New software applications and automation tools, such as low- and no-code solutions, are playing a pivotal role in streamlining operations, extracting richer data insights, and enhancing communication across different parts of a business.
Low- or no-code solutions enable human-centric transformation including user-friendly interfaces that enable rapid application development and configuration without the need for in-depth programming expertise. They also make it easier for companies to access and analyze data, enabling better decision-making to enhance day-to-day business operations.
Thanks to these advantages, low- and no-code platforms are predicted to enable 80% of users outside of formal IT departments to take more ownership of developing solutions that will enhance their MES3.
How to incorporate digital-first MES into operations
By taking a modular and gradual approach to the development of their digital frameworks, companies can integrate new technologies into their MES landscapes alongside existing processes. A robust data enablement strategy that aims to deliver accessible and contextualized data models can help define a single source of truth that should lay the groundwork for data management.
Embracing a more adaptable approach to the implementation process can also allow a company to customize its digitalization strategy to meet its unique needs while creating space to integrate more advanced solutions to strengthen operational efficiencies in the future. Consultation with the team members involved in the processes connected through the MES can help identify the specific needs that the new system should address. This can allow for the flexible modeling and configuring of the solution in line with the unique needs of the company while leaving room to adapt as the business’s requirements evolve.
In addition, new technologies that use cloud-based platforms should have appropriate and defined validation plans for their intended use, without sacrificing their unique advantages and flexibility. Complying with current CSA guidance from the FDA, including ISPE and GAMP guidance for SaaS and PaaS platforms, can ensure that organizations streamline qualification and validation processes and reduce effort by minimizing overhead.
Time to harness next-generation MES
Digital-first MES technology offers key benefits to support the pharmaceutical industry in adapting to a changing market landscape. Adopting it may seem daunting, especially for companies exploring it for the first time. However, by implementing a robust data enablement strategy, taking an adaptable approach to implementation, and preparing effective validation plans in line with CSA guidance, companies can streamline their implementation of digital-first MES. They can be empowered to make their operations more efficient and agile in line with the unique needs of their business.
To find out more about MES solutions from Cognizant visit: MES Solutions for Life Sciences | Cognizant
1 https://onlinelibrary.wiley.com/doi/pdf/10.1002/%28SICI%291099-1786%28199706%292%3A2%3C55%3A%3AAID-QAJ35%3E3.0.CO%3B2-X
2 https://www.manufacturingchemist.com/news/article_page/Promoting_virtual_form_flow_in_the_pharmaceutical_industry/170499
3 https://www.gartner.com/en/newsroom/press-releases/2022-12-13-gartner-forecasts-worldwide-low-code-development-technologies-market-to-grow-20-percent-in-2023