Analytical quality
Internal validation and independent evaluation
Validation and independent evaluation: What changed between validating the method and testing it outside its development setting?
Source editorial review:
Before interpreting the result
What changed between validating the method and testing it outside its development setting?
- Record equipment, personnel, samples and criteria in the original validation.
- Identify which elements were independent in the subsequent evaluation.
- Compare performance within the same analytical purpose and range.
Validation and independent evaluation
Validation documents performance for a defined use and conditions. Independent evaluation can add reproducibility or transfer evidence without making a method universal. Changes in matrix, range, equipment or purpose may require reassessing relevance. The word validated always needs a scope.
A reading case: what to check
If a supplier calls a method validated, ask which application it covers and which characteristics were assessed. If another laboratory reproduces it, compare conditions and results rather than merely its participation. Distinguish claimed validation, available evidence and external evaluation actually performed; none should be inferred from a logo.
What to preserve in the record
Independence adds a check but does not automatically expand the method's scope. Evaluation under new conditions should state its differences and results, not merely the laboratory's name.
Questions and answers
What changed between validating the method and testing it outside its development setting?
Validation documents performance for a defined use and conditions. Independent evaluation can add reproducibility or transfer evidence without making a method universal. Changes in matrix, range, equipment or purpose may require reassessing relevance. The word validated always needs a scope.
What should the review record preserve?
Independence adds a check but does not automatically expand the method's scope. Evaluation under new conditions should state its differences and results, not merely the laboratory's name.