Quality
Analytical method validation and fitness for purpose
The core concepts of specificity, accuracy, precision, range and robustness.
Validation is not a universal quality stamp. It demonstrates that a procedure performs suitably for a defined use, matrix, range and…
02Performance characteristicsSpecificity addresses interference, accuracy closeness to an accepted value, and precision the spread of repeated measurements. Linearity and range connect response…
03Development, validation and lifecycleRobustness is commonly studied during development to understand deliberate small variations. Validation confirms performance under defined conditions, and ongoing monitoring detects…
Intended purpose comes first
Validation is not a universal quality stamp. It demonstrates that a procedure performs suitably for a defined use, matrix, range and result type. An analytical target profile helps define requirements before experiments are selected.
Performance characteristics
Specificity addresses interference, accuracy closeness to an accepted value, and precision the spread of repeated measurements. Linearity and range connect response to amount, while detection or quantitation limits are needed when relevant to the purpose.
Development, validation and lifecycle
Robustness is commonly studied during development to understand deliberate small variations. Validation confirms performance under defined conditions, and ongoing monitoring detects change. The full system is stronger than a one-time test.
LABORATORY APPLICATION
Turning the principle into an auditable record
Start with an analytical target profile describing what will be measured, over which range, with what required uncertainty and for which decision. Then connect each validation experiment to a requirement. This traceability prevents a generic checklist of tests without a clear scientific purpose.
PRIMARY & OFFICIAL SOURCES
Sources and further reading
COMMON QUESTIONS
Questions specific to this topic
Is validation a universal certification?
No. It demonstrates suitability for a defined purpose under specified conditions.
How do accuracy and precision differ?
Accuracy concerns closeness to an accepted value; precision concerns the spread of repeated measurements.
Why assess robustness?
To understand whether small deliberate parameter changes materially affect the result.