Introduction: 

A robust and intelligent test strategy for Manufacturing Execution Systems (MES) like Werum PAS-X is a critical pillar of modern pharmaceutical manufacturing, directly underpinning patient safety and regulatory compliance. This strategy must ensure that electronic Master Batch Records (MBRs) rigorously enforce process parameters, maintain a flawless chain of identity (COI) for materials and products, and seamlessly integrate with the broader digital ecosystem, including LIMS, ERP, and QMS. 

The ultimate goal is to move beyond mere compliance with regulations like 21 CFR Part 11 and towards a state of controlled, efficient, and predictable production. The core of this modern approach is a fundamental principle: test once - avoid duplication, reduce effort. By implementing a risk-based, modular, and automated testing framework, manufacturers can significantly mitigate deviations, accelerate batch release, and build a sustainable model for quality and efficiency. T

he following strategy outlines this structured approach to validating PAS-X Genericl Master Batch Records (GMBRs).

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