Tools, Templates, and Systems for KPI Tracking

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…

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…

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…

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…

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…

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…

Validation Scorecards by Site, Product Line, or Process

Validation Scorecards by Site, Product Line, or Process Validation Scorecards by Site, Product Line, or Process This article serves as a comprehensive step-by-step tutorial for pharmaceutical professionals focused on validation activities related to cleanroom class 1 environments. As per the…

KPI Approval Workflows: Who Owns What Metrics?

KPI Approval Workflows: Who Owns What Metrics? KPI Approval Workflows: Who Owns What Metrics? In the pharmaceutical industry, the establishment and monitoring of Key Performance Indicators (KPIs) are crucial for ensuring compliance with regulatory standards such as the Eudralex Annex…

Building a Central KPI Repository for Validation

Building a Central KPI Repository for Validation Building a Central KPI Repository for Validation In the pharmaceutical and biotech industries, establishing a comprehensive Key Performance Indicator (KPI) repository is essential for effective validation activities. This repository serves as a centralized…

Using GAMP5 Principles to Validate KPI Tracking Software

Using GAMP5 Principles to Validate KPI Tracking Software Using GAMP5 Principles to Validate KPI Tracking Software Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment In the lifecycle of software validation, the first critical step is defining the User…