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 document outlines the functional requirements and expectations of the stakeholders regarding the software tools used for validation metrics tracking. To create a robust URS, stakeholders must consider the primary process validation objectives: accuracy, reliability, and compliance with applicable regulations such as FDA, EMA, and ISO standards. For pharmaceutical sectors, URS must ensure that any filter paper for western blot analysis…

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 to validation, particularly in processes such as cleaning validation, equipment validation, and overall process validation. This article outlines a step-by-step tutorial to guide QA, QC, validation, and regulatory teams through the complete validation lifecycle. Emphasis will be placed on ISO cleanroom standards, particularly as related to ISO 11607-2, alongside documentation and regulatory expectations. Step 1: User Requirement Specification (URS) and…

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 Performance Indicators (KPIs) serve as metrics to evaluate the performance of processes in meeting quality standards. This article provides a comprehensive, step-by-step tutorial on using Excel dashboards for manual KPI monitoring, especially focusing on processes governed by standards such as iso 11607 2 and iso 14644 4. Step 1: Define User Requirements Specification (URS) & Risk Assessment The first step…

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 will emphasize the importance of integrating effective KPI systems, relevant regulatory guidelines, and best practices in validation. Regulatory compliance, particularly under frameworks from the FDA, EMA, and ISO standards, forms the backbone of this process. Step 1: User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle involves the development of a clear User Requirements Specification…

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 validation lifecycle encompasses various stages, including process design, qualification, performance qualification (PPQ), continued process verification (CPV), and revalidation. This article provides a step-by-step tutorial on how to design custom metrics for validation activities, specifically focusing on cleaning validation, a vital component in maintaining product integrity. The guidelines align with the FDA Process Validation Guidance, EU GMP Annex 15, ICH Q8-Q10,…

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 4, EudraLex Annex 11, and PPQ validation. This article provides a comprehensive, step-by-step tutorial, guiding QA, QC, Validation, and Regulatory teams through the lifecycle of KPI input automation using Manufacturing Execution Systems (MES), Quality Management Systems (QMS), and Supervisory Control and Data Acquisition (SCADA) systems. Step 1: User Requirements Specification (URS) and Risk Assessment The first stage of the validation…

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 guidelines established by prominent regulatory bodies including the FDA, EMA, and ICH, systematic validation practices are essential for ensuring the quality and compliance of pharmaceutical products. This guide will take you through the validation lifecycle, encompassing process design, qualification, PPQ, CPV, and revalidation. Step 1: User Requirements Specification (URS) & Risk Assessment The initial phase in any validation lifecycle is…

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 11 and other guidance from organizations like the FDA and EMA. This article provides a step-by-step tutorial on the validation lifecycle related to KPI monitoring, which includes process design, qualification, process performance qualification (PPQ), Continued Process Verification (CPV), and revalidation. Each step is critical for QA, QC, Validation, and Regulatory teams to ensure that metrics are not only defined but…

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 hub for tracking and evaluating the performance of various validation processes, ensuring alignment with regulatory expectations. The focus of this article is to outline a step-by-step tutorial for building and utilizing a KPI repository to enhance ppq validation, pq qualification, and overall process performance in adherence to GMP standards under FDA and EMA guidelines. Step 1: Define User Requirements Specifications…

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 Requirements Specifications (URS). This document outlines what the software is intended to do, aligning it with business objectives as well as regulatory expectations. A thorough URS sets the foundation for validation by capturing all necessary functionalities, including key performance indicators (KPIs) and compliance requirements. The URS must be developed collaboratively with stakeholders such as end-users, quality assurance, and IT to…