It is important to note that GAMP Classification is not the only factor in determining a validation strategy. GAMP 5 advocates for a .
Note: GAMP 5 removed Category 2. Category 3 covers standard software packages that are used "as-is" without any customization or configuration of business processes. Examples include: Standard laboratory equipment software. Firmware for simple instruments.
Essential foundation for risk-based validation, but requires modern interpretation for cloud, AI, and agile methods.