Test Method Validation and Verification

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If a validation or verification study (accuracy, precision, reportable range, etc.) was not performed or is missing required components, the appropriate, related checklist requirements must also be cited (e.g. COM.40300, COM.40350, COM.40400). For an FDA-cleared/approved test, an evaluation of the verification data must address analytical

  Tests, Verification, Methods, Validation, Related, Test method validation and verification