Integrated Approaches to Computer System Validation Within GxP-Compliant Pharmaceutical Quality Management Systems
Authors:-Aditi Akundi, Dr. Pavithra G, Dr. Swapnil SN
Abstract-:The pharmaceutical industry is heavily regulated due to the direct impact of its products on human health and safety. To ensure compliance and maintain data integrity, regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others require that computerized systems used in Good Practice (GxP) environments undergo rigorous validation. Computer System Validation (CSV) plays a pivotal role in ensuring that such systems consistently perform according to their intended use and comply with applicable regulations. This paper provides an in-depth conceptual overview of CSV within the framework of pharmaceutical Quality Management Systems (QMS). It explores its regulatory basis, the validation lifecycle, risk-based approaches, common challenges, and industry best practices, while highlighting the significance of CSV in maintaining quality, compliance, and patient safety.
