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The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Validated test method A test method comprehensively describes all procedures used in sample analysis. Additional documents included each month.
Adapted and non-standard methods must be validated. Protocols are only used for specific projects such as methodvalidation testing or equipment qualification. – Methods for data analysis and interpretation, including the statistical techniques to be used.
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