Introducing the Composable MES for Pharma

At Operations Calling 2024, we announced the Composable MES for Pharma, an extension of the cMES App Suite, to accelerate digital transformation in the pharmaceutical industry.

The Composable MES (Manufacturing Execution System) for Pharma is a foundational set of applications that enable pharmaceutical companies to rapidly deploy electronic batch records, logbooks, and batch production management solutions in their production environments. This collection of apps showcase the art of what is possible when pharmaceutical manufacturers bring MES and eBR functionality to the frontlines through human-centric apps.

In the Composable MES for Pharma, you can leverage pre-built templates as building blocks to compose tailored solutions that perfectly meet your process requirements. With Tulip’s drag-and-drop interface and easy-to-define trigger logic, you can build powerful, human-centric applications that your frontline operators can use to log events, monitor critical process parameters, and manage exceptions in real time.

All apps in the Composable MES for Pharma are built on the Common Data Model, allowing you to easily contextualize data at the point of capture, ensuring data accuracy and enhancing decision-making when conducting eBR reviews, audits, or business decisions.

The Common Data Model is a data schema that unifies data on all applications in the Composable MES for Pharma, creating a single source of truth. Unlike conventional MES systems that impose predefined data models requiring customizations from vendors or system integrators, this model offers a flexible foundation you can configure and extend as your needs change and evolve. It is designed to streamline data exchange, uphold data integrity, and support collaborative efforts, meeting the critical needs of the pharmaceutical sector.

Within the Common Data Model's framework lies a foundation rooted in industry best practices, human-centric design, and flexibility. This core design empowers pharmaceutical manufacturers to not only adapt but also evolve their data strategies to meet changing regulatory demands, critical process parameters (CPPs), and critical quality attributes (CQAs). For instance, consider a scenario where a pharmaceutical company must conform its manufacturing processes to new regulatory standards. The adaptable nature of the Common Data Model allows seamless integration of these new requisites into the existing data structure, ensuring compliance without disrupting operational flows. Because the Common Data Model is composable, it facilitates the creation of fresh use cases that seamlessly integrate atop the existing structure, addressing emerging challenges and bolstering operational capabilities.

With provisions for handling various artifacts—be they physical, like inventory items, or operational, like work orders—the Common Data Model offers a holistic view of your manufacturing landscape in a human-readable way. The incorporation of shared logs in the model establishes a centralized data repository for applications to track historical information, enabling informed decision-making and process enhancements based on past performance. By emphasizing contextual references to processes, the Common Data Model enriches data interpretation, fostering a more comprehensive and insightful approach to pharmaceutical manufacturing data management.

In the pharmaceutical industry, Electronic Batch Records (eBR) management is a critical process that demands precision, efficiency, and reliability. Composability stands out as a transformative solution, offering tailored systems that streamline eBR operations while ensuring regulatory compliance.

The Electronic Batch Record (eBR) App Suite offers a collection of apps demonstrating how an electronic batch record will eliminate paper from your production floor, giving you the operational efficiency to expedite batch releases. This suite provides digital guidance to your operations, ensuring error-proof workflows at every point, from weigh and dispense operations to packaging procedures. By incorporating real-time exception handling and data validation capabilities, the eBR suite enables swift identification and resolution of quality issues, significantly reducing the occurrence of deviations. Moreover, the eBR review app within this suite facilitates review-by-exception workflows, reducing review times and the burden of compliance.

While these apps use small molecule manufacturing as an example, pharmaceutical manufacturers of all types can leverage the app templates to implement tailored solutions that accelerate batch release, ensure compliance, and enhance overall quality.

The Batch Production Management App Suite within the Composable MES for Pharma serves as a robust solution for streamlining production processes and maximizing operational visibility. This suite centralizes crucial production data on a user-friendly dashboard, providing at-a-glance insights into equipment statuses, batch progression, and key production metrics. Moreover, these dynamic dashboards are accessible and optimized for display on various devices, including computers, tablets, and mobile devices, ensuring data availability wherever it's needed. With real-time production visibility at your fingertips, you can make more informed decisions that shorten the time to resolution on open exceptions and optimize operations on your production floor.

The Electronic Logbook App Suite provides a logbook app that guides operators through various SOPs in real time, minimizing errors and ensuring compliance with set protocols. By automating documentation during execution, electronic logbooks maintain data integrity and streamline record-keeping processes. Offering easily accessible and searchable records of equipment activities, it simplifies review cycles with easy-to-retrieve information. Leveraging the Common Data Model, these logbooks facilitate seamless data sharing across other apps in the Composable MES for Pharma, supporting review-by-exception procedures, data analysis, and maintenance requests. Through these functionalities, electronic logbooks not only enhance operational efficiency but also significantly contribute to maintaining high standards of quality assurance and compliance.

If you're interested in seeing how Tulip's Composable MES can help improve the way you're running your pharmaceutical operations, reach out to a member of our team today!