Apotex is putting multiple sites in one global MES paperless EBR system to create fast workflows, loose paper recipes completely and discuss best practice validation approaches and its requirements. The goal is to achieve one global template followed by an agile MES rollout on all sites and to find a way in doing so that is compliant and efficient at the same time. In her talk Esra is going to show us how to start an MES execution with the architecture set-up, rollout methodologies to use and requirements, features, and benefits of paperless and agile MES validation.
This presentation covers:
- How to structure your CSV documents and tools: Global policy and procedures and CSV master plan
- High Quality CSV SOPs, their requirements and how to develop them
- High Quality CSV templates and MES validation deliverables
- Requirements of paperless MES validation, its features, and benefits of paperless validation
- MES agile validation
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