Risk Based Approach to Computerized System Validation

The purpose of this review is to provide comprehensive guide for Computer System Validation CSV for the life sciences industry. Computerized System Validation CSV is a fundamental practice in the regulated life science industry, serving as the backbone for maintaining product quality, patient safety, and data integrity in an era of global digitalization. The traditional, resource intensive box tickling approach to CSV struggles to keep pace with the increasing complexity of modern computer systems, evolving regulatory landscapes, and the constraints of time and budget. This review explores the transition to a more strategic, risk based approach to CSV, which prioritizes validation activities based on their potential impact on GxP regulated processes. The internationally recognized GAMP 5 framework is presented as a cornerstone of this methodology, providing a systematic approach to categorize software and tailor validation activities accordingly. Also, this review article outlines the purpose of CSV, the challenges it faces, and the specific types of GxP regulated systems subject to validation. It further details the phases of a risk based CSV lifecycle, from initial GxP impact and supplier assessments to change control, emphasizing the shift from extensive, redundant testing towards a more focused, critical thinking based effort. Ultimately, adopting a risk based approach enhances efficiency, reduces the burden of documentation, and reinforces data integrity and regulatory compliance. Kirankumar Patel "Risk-Based Approach to Computerized System Validation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-9 | Issue-5 , October 2025, URL: https://www.ijtsrd.com/papers/ijtsrd97461.pdf Paper URL: https://www.ijtsrd.com/computer-science/other/97461/riskbased-approach-to-computerized-system-validation/kirankumar-patel