# Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (notified under document number C(2002) 3044) (Text with EEA relevance) (2002/657/EC), Division 3.1.3: Validation according to alternative models

Extent: E+W+S+N.I.

When alternative validation procedures are applied, the underlying model and strategy with the respective prerequisites, assumptions and formulae shall be laid down in the validation protocol or at least references shall be given to their availability. In the following an example for an alternative approach is given. When applying e.g. the in-house validation model, the performance characteristics are determined in a manner that permits validation for major changes within the same validation procedure. This requires design of an experimental plan for validation.

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Source: https://www.legislation.gov.uk/eudn/2002/657/annex/chapter/3.1/division/3.1.3 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-657/annex/chapter-3.1/division-3.1.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.