Computer System Validation in the Pharmaceutical Industry
Introduction: The pharmaceutical industry plays a crucial role in the development and manufacturing of life-saving drugs and medical devices. With the advancements in technology, computer systems have become an integral part of various processes, ranging from research and development to production and quality control. However, to maintain the highest standards of quality, safety, and regulatory compliance, the pharmaceutical industry relies on a process called Computer System Validation (CSV). In this article, we will explore the significance of CSV in the pharmaceutical industry and its role in ensuring the integrity and reliability of computerized systems. 1. The Importance of Computer System Validation: Computer systems used in the pharmaceutical industry, such as laboratory information management systems (LIMS), manufacturing execution systems (MES), and enterprise resource planning (ERP) systems, are critical components of the regulatory compliance framework. CSV is the process b