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<p>Pharma 4.0 is a terminology derived from Industry 4.0 and used to describe the adaptation of those concepts in the pharmaceutical industry. Due to the more conservative nature of the pharmaceutical sector and stringent requirements for introducing new technologies into regulated environments, additional challenges must be overcome compared to Industry 4.0 in other sectors. This work introduces the Data Computation Platform (DCP), a microservice-based browser application that enables advanced analytics, reporting, and real-time monitoring of manufacturing processes, scaled across the global manufacturing network of a pharmaceutical company. The architecture and implementation concept of DCP effectively addresses key challenges specific to the pharmaceutical industry in adopting Industry 4.0 innovations. Notably, DCP enhances operational efficiency by streamlining development cycles and simplifying the deployment of components into the regulated environment following computerized system validation. A core strength of DCP is its architecture, designed from the ground up to ensure built-in compliance with GxP regulations, making it uniquely suited for GxP and non-GxP applications. This provides a significant advantage over conventional systems by offering seamless integration with regulatory requirements. The paper also presents a use case from a Drug Product manufacturing site, demonstrating DCP’s capabilities in process health supervision and predictive maintenance.</p>

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Data computation platform (DCP): empowering pharma 4.0 innovation through GxP-compliant and scalable software platform enabling advanced data analytics and real-time process monitoring in regulated environments

  • 期刊论文

  • 发表日期：

    2025年1月31日

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  • Tobias Ladner,
  • Christopher Weh,
  • Anoop Dhillon,
  • Marion Giffard,
  • Daniele Iacovelli

摘要

Pharma 4.0 is a terminology derived from Industry 4.0 and used to describe the adaptation of those concepts in the pharmaceutical industry. Due to the more conservative nature of the pharmaceutical sector and stringent requirements for introducing new technologies into regulated environments, additional challenges must be overcome compared to Industry 4.0 in other sectors. This work introduces the Data Computation Platform (DCP), a microservice-based browser application that enables advanced analytics, reporting, and real-time monitoring of manufacturing processes, scaled across the global manufacturing network of a pharmaceutical company. The architecture and implementation concept of DCP effectively addresses key challenges specific to the pharmaceutical industry in adopting Industry 4.0 innovations. Notably, DCP enhances operational efficiency by streamlining development cycles and simplifying the deployment of components into the regulated environment following computerized system validation. A core strength of DCP is its architecture, designed from the ground up to ensure built-in compliance with GxP regulations, making it uniquely suited for GxP and non-GxP applications. This provides a significant advantage over conventional systems by offering seamless integration with regulatory requirements. The paper also presents a use case from a Drug Product manufacturing site, demonstrating DCP’s capabilities in process health supervision and predictive maintenance.