This presentation will provide a guide to implementing a Manufacturing Execution System in a multi-product GxP regulated pharmaceutical facility. Attendees will gain a deeper understanding of the unique challenges and barriers faced during this process and learn how agile project methodology can be leveraged to ensure successful implementation. In this session, you will learn how to:
- Navigate Uncertainty: Strategies for defining requirements when traditional user requirement specifications are not feasible.
- Overcome Barriers: Addressing the challenges of implementing a paperless batch record system in a multi-product CMO requiring integration with ERP and Automation System.
- Develop Proof of Concept: Starting with a low investment pilot trial license and a single initial environment to demonstrate the benefits of core MES functionalities.
- Adopt a Phased Approach: Utilising a phased approach to manage complexity and ensure alignment between automation, production, operations, and quality teams.
- Comply: Incorporating a GxP risk-based approach and documentation throughout the project
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