Introduction Change control is a critical component of Computerized System Validation (CSV), ensuring that any modifications to validated systems are systematically evaluated, documented, and implemented without compromising the integrity, compliance, or intended use of the system. In regulated industries such as pharmaceuticals, biotechnology, and medical devices, where computerized systems manage data impacting product quality and patient safety, a robust change control pro

Introduction Data integrity is a cornerstone of compliance in the life sciences and pharmaceutical industry. As regulatory agencies such as the FDA, EMA, MHRA, and WHO place increasing emphasis on trustworthy and reliable data, organizations must ensure that computerized systems used in Good Manufacturing Practices (GMP) environments meet stringent standards. One critical area where this comes into play is Computerized System Validation (CSV) . CSV ensures that systems perfor

Introduction FDA 21 CFR Part 11 is a significant regulation that oversees the utilization of electronic signatures and electronic records...

Introduction CSV (Confidentiality, Security, and Availability) and CSA (Cloud Security Alliance) are two key terms in the field of data...