Method Validation Table
Summary of the method validation algorithms
|
Parameter |
LITE |
DEMO |
FULL |
|
|
|
Algorithms included: |
|
|
Repeatability |
1 |
2 |
2 |
|
Intermediate Precision |
|
1 |
1 |
|
Reproducibility |
|
2 |
2 |
|
Accuracy |
1 |
8 |
8 |
|
Linearity |
|
4 |
4 |
|
LOD / LOQ |
|
5 |
5 |
|
Selectivity/Specificity |
|
3 |
3 |
|
Robustness/Ruggedness |
|
1 |
1 |
|
Sensitivity |
|
2 |
2 |
|
Blank |
|
1 |
1 |
|
System Suitability Test: FDA |
|
5 |
5 |
|
System Suitability Test: Ph.Eur. |
|
3 |
3 |
|
Inter-laboratory Comparison |
|
3 |
3 |
|
Calibration |
1 |
2 |
2 |
|
Control Charts (SPC) |
1 |
5 |
5 |
|
Uncertainties |
1 |
6 |
6 |
|
Electronic Record Books |
|
9 |
9 |
|
Software Validation |
YES |
YES |
YES |
|
Access and Signature Control |
YES |
YES |
YES |
|
