Regulatory Expectations for Metrics and KPIs

Risk-Based KPI Justification for Critical Validation Areas

Risk-Based KPI Justification for Critical Validation Areas Risk-Based KPI Justification for Critical Validation Areas The validation lifecycle in pharmaceutical manufacturing encompasses several critical steps designed to ensure compliance with regulatory expectations and maintain product quality. Among these steps, a focus…

Presenting KPI Dashboards to Regulatory Agencies

Presenting KPI Dashboards to Regulatory Agencies Presenting KPI Dashboards to Regulatory Agencies In the highly regulated pharmaceutical industry, presenting Key Performance Indicator (KPI) dashboards effectively to regulatory agencies is crucial for compliance and operational excellence. This article will provide a…

Real-Life Audit Findings Related to KPI Gaps

Real-Life Audit Findings Related to KPI Gaps Real-Life Audit Findings Related to KPI Gaps In the pharmaceutical and biologics industries, adherence to established guidelines and standards is crucial for ensuring product quality and compliance. This requirement necessitates an understanding of…

Global Regulatory Differences in Validation Performance Monitoring

Global Regulatory Differences in Validation Performance Monitoring Global Regulatory Differences in Validation Performance Monitoring In the pharmaceutical industry, validation is a critical component of ensuring product safety, efficacy, and quality. Regulatory agencies across the globe, including the FDA, EMA, and…

SOPs to Support Metric Collection, Review, and Action

SOPs to Support Metric Collection, Review, and Action SOPs to Support Metric Collection, Review, and Action The validation lifecycle in pharmaceutical manufacturing is governed by a myriad of regulatory expectations. Central to this process is the implementation of metrics that…

Key Validation KPIs That Trigger CAPA and Revalidation

Key Validation KPIs That Trigger CAPA and Revalidation Key Validation KPIs That Trigger CAPA and Revalidation In the pharmaceutical industry, understanding and monitoring key validation performance indicators (KPIs) is essential for compliance and overall product quality. Key validation KPIs are…