In this presentation, Esra outlines a strategic approach to achieving compliance and audit readiness for Manufacturing in Pharma. She delves into the software setup, system design, regulatory requirements and data integrity. In this session, you will learn:
- What are the main regulation requirements for a Manufacturing Execution Software?
- What are the specifice Electronic Records and Electronic Signatures requirements?
- How to design Manufacturing systems to be compliant?
- How to establish and maintain Data Integrity for Manufacturing?
- How to be Audit ready for Manufacturing systems?
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