Digitalisation’s potential to increase productivity and profitability is widely acknowledged, yet the journey towards a fully digitalised process can be a daunting one. This is especially the case for production plants on the lower end of the digital maturity scale. Therefore, to open the Pharma 4.0 Roadmap for Implementation track, the winning solution from the 2021 ISPE Student & Recent Graduate International Hackathon will be presented, providing a highly practical and innovative example of how to commence the digitalisation journey by capitalising on current infrastructure and resources.
The 2021 ISPE Hackathon, with a problem statement provided by Bayer, required participants to propose a lean solution to convert paper-based batch record documentation into a digital, readable format, without relying on retrospective digitalisation. Strict constraints were also imposed, including covid restrictions, budget limitations and committed production volumes, hence eliminating solutions that would require a production shutdown. This presentation will also explain the priority areas for digitalisation identified in the solution, using the example of an OSD production process for contextualisation. This is then further developed into a comprehensive, high-level digitalisation roadmap, highlighting all the advantages of a fully digitalised process. The roadmap includes an implementation plan based on the principles of agile development, budget estimation, GMP and data integrity assessment, and review of technology requirements.