Software/Spreadsheet Validation

Validating Data Transfers in Software Systems

Validating Data Transfers in Software Systems Validating Data Transfers in Software Systems Validating data transfers in software systems is a crucial aspect of ensuring compliance and integrity in the pharmaceutical industry. This step-by-step tutorial outlines the validation lifecycle, detailing essential…

How to Handle Software Updates and Revalidation

How to Handle Software Updates and Revalidation How to Handle Software Updates and Revalidation In the rapidly evolving landscape of the pharmaceutical industry, ensuring compliance with regulatory requirements while managing software updates and revalidation has become a critical focus for…

Spreadsheet Change Control SOP Template

Spreadsheet Change Control SOP Template Spreadsheet Change Control SOP Template In today’s pharmaceutical environment, the efficacy of computer systems plays a critical role in maintaining compliance and ensuring product quality. This article outlines a comprehensive step-by-step approach to computer system…

Common FDA 483s Related to Software Validation

Common FDA 483s Related to Software Validation Common FDA 483s Related to Software Validation Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation of effective computer system validation in pharma begins with a well-defined User Requirements Specification…

GAMP 5 Approach for Configurable Software Validation

GAMP 5 Approach for Configurable Software Validation GAMP 5 Approach for Configurable Software Validation In the ever-evolving pharmaceutical industry, the importance of software validation cannot be overstated. Particularly, computer system validation (CSV) serves a critical role in ensuring that software…

Spreadsheet Template Library for Quality and Manufacturing

Spreadsheet Template Library for Quality and Manufacturing Spreadsheet Template Library for Quality and Manufacturing In the pharmaceutical industry, the integrity and accuracy of data are paramount to ensure compliance with regulatory requirements. This necessitates a robust framework for computer system…