Applying the GAMP5 Framework in an Agile GxP Validation Project
A risk-based approach is a cornerstone of modern GxP validation approaches. It focuses resources where they matter most, ensuring patient safety and product quality while optimizing efficiency.
GAMP 5 (Good Automated Manufacturing Practice) is a widely recognized framework for the validation of computerized systems in the pharmaceutical and life sciences industries. It provides a risk-based approach to validation, emphasizing a structured, risk-based approach to validation, covering the entire system lifecycle, from initial concept and design to retirement. As IT organizations mature and rely increasingly on Agile methodologies, GAMP 5 principles can be applied – even thought they seem to represent different approaches at first glance.
By combining the best practices of GAMP 5 and Agile, organizations can develop and validate high-quality software that meets regulatory requirements and delivers value to users in a timely and efficient manner.
