Overview of modules and regulatory requirements
Cross reference table:
| Module in EffiValidation 3.0 software | ISO 17025 requirements | GxP practices |
|---|---|---|
| Method validation | Chapter 5.4.5 | ICH Q2(R1) |
| Uncertainties | Chapter 5.4.6 | – |
| Control charts | Chapter 5.9 | – |
| Calibration | Chapter 5.4.1 | – |
| Inter-laboratory comparison | Chapter 5.9.1, 5.6.1 | – |
| Electronic Laboratory Logbooks | Chapter 5.5 and 5.6 | 21 CRF Part 11 |
| Software validation | Chapter 5.4.7.2 | GAMP® 5 |
