Tag: Computer System Validation (CSV)

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 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…

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…

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,…

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…

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…

Using Audit Trail Printouts as Evidence in Regulatory Inspections

Using Audit Trail Printouts as Evidence in Regulatory Inspections Using Audit Trail Printouts as Evidence in Regulatory Inspections Audit trails play a pivotal role in maintaining data integrity and ensuring compliance during regulatory inspections. For Quality Assurance (QA) and Quality…

How to Validate Systems That Store GMP Data

How to Validate Systems That Store GMP Data How to Validate Systems That Store GMP Data Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle for computer systems that will store GMP…

Data Integrity Training Programs for QA and IT

Data Integrity Training Programs for QA and IT Data Integrity Training Programs for QA and IT In the highly regulated pharmaceutical industry, ensuring data integrity within computerized systems is critical for compliance with global regulations such as FDA guidelines, EMA…

Role-Based Access Controls for Data Security in CSV

Role-Based Access Controls for Data Security in CSV Role-Based Access Controls for Data Security in CSV In the pharmaceutical and biologics sectors, ensuring the integrity of data through robust validation processes is critical. Computerized system validation (CSV) is a fundamental…