Tag: FDA guidelines

KPI Input Automation via MES, QMS, and SCADA Systems

KPI Input Automation via MES, QMS, and SCADA Systems KPI Input Automation via MES, QMS, and SCADA Systems Managing Key Performance Indicators (KPIs) in pharmaceutical manufacturing requires a meticulous approach, particularly when adhering to regulatory standards such as iso 14644…

Designing Custom Metrics for Validation Activities

Designing Custom Metrics for Validation Activities Designing Custom Metrics for Validation Activities In the pharmaceutical industry, validation is a critical aspect to ensure that products are developed and manufactured in a manner that ensures their quality, safety, and efficacy. The…

Cloud-Based KPI Systems for Cross-Site Validation Oversight

Cloud-Based KPI Systems for Cross-Site Validation Oversight Cloud-Based KPI Systems for Cross-Site Validation Oversight This article serves as a comprehensive guide for pharmaceutical professionals focusing on the validation lifecycle, particularly in the context of ISO 11607-2. Throughout this tutorial, we…

Using Excel Dashboards for Manual KPI Monitoring

Using Excel Dashboards for Manual KPI Monitoring Using Excel Dashboards for Manual KPI Monitoring In the pharmaceutical and biotech industries, compliance with regulatory standards such as ICH Q8–Q10, FDA Process Validation Guidance, and EU GMP Annex 15 is vital. Key…

KPI Template for Cleaning, Equipment, and Process Validation

KPI Template for Cleaning, Equipment, and Process Validation KPI Template for Cleaning, Equipment, and Process Validation The pharmaceutical industry places a strong emphasis on meeting regulatory requirements and ensuring product quality. To achieve this, professionals must undertake a systematic approach…

Top Software Tools for Validation Metrics Tracking in Pharma

Top Software Tools for Validation Metrics Tracking in Pharma Top Software Tools for Validation Metrics Tracking in Pharma Step 1: Understanding User Requirements Specifications (URS) & Risk Assessment The validation lifecycle begins with a well-defined User Requirements Specification (URS). This…

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…

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…

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…

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…