QMS-Linked Validation Performance Indicators: Pharma Metrics for Quality and Compliance

QMS-Linked Validation Performance Indicators: Pharma Metrics for Quality and Compliance How to Link Validation KPIs with Pharma QMS for Enhanced Compliance and Performance Monitoring Introduction Pharmaceutical manufacturers are under increasing pressure to demonstrate that their validation programs are not isolated technical activities, but integral components of the overall Quality Management System (QMS). Regulators like the FDA, EMA, and WHO expect validation performance to be tracked, trended, and linked with QMS indicators such as CAPA closure rates, deviation frequencies, change control effectiveness, and audit findings. This article provides a comprehensive guide to defining, measuring, and using QMS-linked validation performance indicators to…

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