Computer System Validation (CSV)

Electronic Logs and Their Role in Ensuring Data Integrity

Electronic Logs and Their Role in Ensuring Data Integrity Electronic Logs and Their Role in Ensuring Data Integrity In the rapidly evolving pharmaceutical industry, ensuring data integrity is crucial, especially with the increasing reliance on computerized systems. This article will…

How to Review Electronic Records for Completeness and Accuracy

How to Review Electronic Records for Completeness and Accuracy How to Review Electronic Records for Completeness and Accuracy In the pharmaceutical industry, ensuring the integrity and reliability of electronic records is crucial to meeting regulatory standards. This article specifically addresses…

Data Lifecycle Management in CSV-Validated Systems

Data Lifecycle Management in CSV-Validated Systems Data Lifecycle Management in CSV-Validated Systems In the field of pharmaceuticals, effective data lifecycle management in computer system validation (CSV) is critical for ensuring compliance with strict regulatory requirements. This article provides a comprehensive,…

Annex 11 vs ALCOA+: Where They Intersect

Annex 11 vs ALCOA+: Where They Intersect Annex 11 vs ALCOA+: Where They Intersect This article provides a comprehensive step-by-step validation tutorial focusing on sterilisation validation in the context of regulatory frameworks such as GMP, FDA, and EMA. The content…

Spreadsheet Validation in Pharma: Step-by-Step Guide

Spreadsheet Validation in Pharma: Step-by-Step Guide Spreadsheet Validation in Pharma: Step-by-Step Guide In the pharmaceutical industry, the integrity and reliability of data generated through software applications, especially spreadsheets, is critical. This article outlines a comprehensive step-by-step guide for validating spreadsheet…

How to Validate Excel Calculations Used in GMP Operations

How to Validate Excel Calculations Used in GMP Operations How to Validate Excel Calculations Used in GMP Operations In the highly regulated pharmaceutical industry, the accuracy and reliability of data generated through Excel calculations are paramount. This article provides a…

Spreadsheet Inventory and Risk Assessment Template

Spreadsheet Inventory and Risk Assessment Template Spreadsheet Inventory and Risk Assessment Template This article provides a comprehensive step-by-step tutorial on implementing a spreadsheet inventory and risk assessment within the context of kneat validation. This approach aligns with regulatory frameworks, including…

Validation of Off-the-Shelf Software in GxP Systems

Validation of Off-the-Shelf Software in GxP Systems Validation of Off-the-Shelf Software in GxP Systems In today’s regulated environments, the validation of off-the-shelf software in Good Practice (GxP) systems is crucial for compliance and maintaining data integrity. This article serves as…

Macro and Formula Locking Techniques for GMP Spreadsheets

Macro and Formula Locking Techniques for GMP Spreadsheets Macro and Formula Locking Techniques for GMP Spreadsheets In the realm of pharmaceutical manufacturing and quality control, ensuring data integrity and compliance is paramount. Effective gxp validation plays a critical role in…

IQ/OQ for Software Systems: What Needs to Be Documented

IQ/OQ for Software Systems: What Needs to Be Documented IQ/OQ for Software Systems: What Needs to Be Documented In the highly regulated pharmaceutical and biotechnology industries, ensuring compliance through rigorous validation procedures is paramount. This article provides an in-depth, step-by-step…