The Validation Report and Scientific Review

A validation report that describes overall conduct of the validation, and includes all of the relevant tables needed to support the interpretation of results and final conclusions, should be written prior to initiating sample analysis. The report should be assigned a unique identification number that can be used as a reference in the sample analytical report. A cover page should contain, at a minimum, the name and address of the laboratory and the report and amendment number (if applicable). A signature page that includes, at a minimum, the author(s), reviewer(s) and laboratory management should also be included. 

For methods which require an additional qualitative identification component, snch as an FDA method for the analysis of pesticide residnes in food (Section 10.4.3a), the analysis of the validation data shonld be reviewed from the perspective of whether or not the resnlts snpport the need to demonstrate an extremely low risk for false positives. In this respect, a zero rate of false positives refers to method validation, nnder controlled circnmstances with known samples. If there is one false positive for a confirmatory method, the validation shonld be failed. 

For other applications thatreqnire reporting of data below the LLOQ, the report shonld address the region of nncer-tainty discussed previonsly in Section 9.3.2, in terms of how the data wiU be interpreted and how the final resnlts will be reported for identification and qnantitation. 

The remainder of this section addresses some of the specific requirements of the validation report. These requirements are drawn from a recently pnblished paper published by the US FDA and other indnstry collaborators (Viswanathan 2007) and are an extension of the requirements described in Section 10.3.3 which were also derived from the same docnment. Once again, althongh these requirement were written specifically for laboratories 

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