If you’ve been in computerized system validation (CSV) for more than a decade, you remember GAMP 4’s rigid “V-model” and exhaustive documentation. Then GAMP 5 arrived in 2008 (updated in 2022), shifting focus from heavy documentation to critical thinking and risk-based validation .
GAMP 5 explicitly links validation effort to risk to patient safety, product quality, and data integrity . 2. Software Categories: Major Shift | GAMP 4 | GAMP 5 | |-------------|-------------| | 1. Operating systems | 1. Infrastructure software | | 2. Firmware | 3. Non-configurable products | | 3. Standard software packages | 4. Configurable products | | 4. Configurable software | 5. Custom applications | | 5. Custom software | | gamp 4 vs gamp 5
Switch to critical thinking. Reduce waste. Validate smarter. If you’ve been in computerized system validation (CSV)
But what exactly changed? And do you still need to follow GAMP 4? Infrastructure software | | 2
Let’s break it down. | Aspect | GAMP 4 | GAMP 5 | |------------|-------------|---------------| | Approach | One-size-fits-all | Scalable, risk-driven | | Mindset | “Validate everything” | “Validate what matters” | | Key driver | Compliance checklists | Product quality & patient safety |