Method validation aims to show, for a defined intended use, that a procedure produces sufficiently consistent and fit-for-purpose results. Characteristics, criteria and data should be planned before performance is interpreted.
Intended use
Analyte, matrix, range, equipment, conditions and purpose should be clear before performance characteristics are chosen.
Performance characteristics
Depending on the method, precision, repeatability, linearity, range, recovery, selectivity, limits or robustness may matter.
Data plan and criteria
Replicates, levels, controls, calculations and acceptance criteria should be planned before results are seen.
Report and limitations
The report shows data, calculations, deviations and a conclusion proportional to the tested scope.
Possible deliverables
How the work is organised
The objective, available documents and data are reviewed first; scope, deliverables, missing information and review points are then defined. Support may cover one phase or connect with methodology, laboratory work, analysis and reporting.
Frequently asked questions
Does Sandra issue validation certificates?
No. Support covers planning, analysis and documentation; formal approval remains with the organisation.
Can a completed validation be reviewed?
Yes. Plan, calculations, criteria, results and conclusions can be reviewed.
Do all methods need the same parameters?
No. Parameters depend on purpose, matrix, technique, range and result type.