As pharmaceutical and life sciences companies increasingly rely on digital systems, ensuring those systems are reliable, secure, and compliant has never been more critical. Two terms often used, sometimes interchangeably, are Computer System Validation (CSV) and Computer Software Assurance (CSA). While both aim to protect data integrity and patient safety, they represent different approaches to achieving compliance. For students and professionals in quality and regulatory roles, understanding how CSV and CSA differ is essential to navigating modern pharmaceutical environments. What Is Computer System Validation (CSV)? Computer System Validation is a long-established regulatory expectation in pharmaceutical manufacturing and clinical research. CSV.. READ MORE »
Change control is one of the most critical pillars of pharmaceutical quality systems. Whether the change involves equipment, raw materials, documentation, processes, utilities, or computerised systems, every modification must be evaluated, justified, and implemented in a controlled manner. For quality teams and students pursuing the Quality Assurance and Quality Control Diploma, mastering this process is essential for ensuring compliance, product integrity, and patient safety. This step-by-step guide breaks down the core components of a compliant and effective change control workflow used throughout the pharmaceutical industry. Step 1: Initiate the Change A change begins with a clear, well-documented request. This includes.. READ MORE »
