944298
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Biassono (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |