Abstract

RECENT ADAPTATION OF COMPUTER SYSTEM ASSURANCE IN PLACE OF COMPUTER SYSTEM VALIDATION: AN OVERVIEW

Rishabh Baksar, Dr. Gurmeet Chhabra*, Dr. Nimita Manocha and Dr. Ritesh Patel

ABSTRACT

As computer systems play a more critical role in regulated industries like pharmaceuticals, biotech, and medical devices, validating their reliability and compliance is essential. Computer System Validation (CSV) has traditionally been the cornerstone of compliance by means of comprehensive documentation and scripted testing. Unfortunately, this conventional method will ultimately result in inefficiencies, delay, and excessive focus on documentation as opposed to product quality and patient safety. The U.S. FDA responded to these challenges with Computer Software Assurance (CSA), a new, risk-management approach designed to simplify validation procedures while maximizing quality results. CSA stimulates critical thinking, targets testing resources towards high-risk areas, and induces the execution of automated and unscripted testing to enhance efficiency and effectiveness. This paper delves into the history of CSV, the development towards CSA, and the main distinctions between the two methods. It further explores the issues organizations might encounter in implementing CSA, the intangible advantages of this paradigm shift, and practical implementation through case studies. Lastly, the paper takes a glimpse into the future of computer system compliance as the industry is further moving towards digital transformation, agile practices, and continuous assurance models.

Keywords: Computer System Validation, Computer System Assurance, CSV vs CSA, Challenges of CSA, Adaptation of CSA, Future of CSA.