You work in non-regulated software (web dev, finance non-GxP), or you’re fully cloud-native with no GxP requirements – look at CSA instead.
| Framework | Focus | Best for | |-----------|-------|----------| | | Pharma/med device validation | Regulated industry with audit pressure | | ISO 62304 | Medical device software | Device software + risk classes (A/B/C) | | CSA (Critical Systems Assurance) | Modern, data-centric | Cloud, agile, AI – less document-heavy | gamp classification
Using GAMP categories allows organizations to move away from a "one size fits all" validation strategy. By identifying low-risk, standard systems (Category 3) versus high-risk, custom systems (Category 5), companies can ensure regulatory compliance while maintaining operational efficiency. What is GAMP®? | ISPE You work in non-regulated software (web dev, finance
Misclassifying a system can lead to significant business consequences. What is GAMP®