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How much validation is required?
The amount of effort required to validate a method will depend on the criticality of the measurement, the scope of the method and the level of information and experience already available. Not all of the performance parameters described under ‘Method performance parameters’ will be relevant for every test method.
If the test method has been developed in-house from scratch by a single laboratory then a significant amount of validation will be required. However, demonstrating the performance of a well established standard method that has been validated via a collaborative study will probably require less effort.
The key factor is that an individual laboratory must have sufficient information about the performance of the method to have confidence that the method is appropriate for the task at hand and capable of producing reliable results that are fit for purpose.
Last modified on
07 March 2008.