Chemistry
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Chemistry Validation Plan Template v.1.0
- Audit Reference: Verification of Performance Specification Example of Validation plan for Chemistry.
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Chemistry Validation Summary Template v.1.2
- Audit Reference: Verification of Perfomance Specification Example of summary for validation
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Precision Requirements-Chemistry v.1.0
- Audit reference: Verification of Performance Specification - SMILE suggestions for precision validation.
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Precision requirement Chemistry Total Allowable Error Table v2.0
- Audit Reference Specification of Performance Verification
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Accuracy Requirements-Chemistry v.1.0
- Audit reference: Verification of Performance Specifications - SMILE suggestions for validation of accuracy for Chemistry analytes.
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SMILE Accuracy Requirements Chemistry Appendix 2 Total Error Table v.2.0
- Audit reference:Verification of Performance Specifications - Total Error table for Chemistry analytes to use in accuracy validation.
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SMILE Accuracy Chemistry Appendix 3 Two Instrument Comparsion Example Report v.1.0
- Audit reference: Verification of Performance Specification - Example of a Two instrument comparsion for Chemistry Accuracy Validation
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SMILE Accuracy Chemsitry Appendix 4 Alternate Method Comparison Example Report v.1.0
- Audit reference: Verification of Performance Specifications - Example of alternate method comparision report for Accuracy Validation
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SMILE Accuracy Chemistry Appendix 6 Six Sigma Example Report v.1.0
- Audit reference: Verification of Performance Specifications - Example of a report using Six Sigma for Accuracy Validation GCLP Guideline -Appendix 11
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Chemistry Linearity Requirements
- Audit reference: Verification of Performance Specifications - SMILE suggestions for validation of linearity for Chemistry analytes.
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Linearity -Chemistry Appendix 2 Linearity Example EP Report v.1.0
- Audit reference: Verificaiton of Performance Specifications - Example of a report for linearity validation.
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SMILE Linearity Chemistry Appendix 3 SMILE Total Error Table v.2.0
- Audit reference: Verification of Performance Specifications - Table for Total error values for Chemistry analytes.
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AMR And CRR Requirement for Chemistry
- Audit Reference:Verification of Performance Specification Total Error Table for Chemistry Analytes
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SMILE AMR and CRR Requirements Appendix 1 SMILE Chemistry TE Table v.2.0
- Audit Reference:Verification of Performance Specification Total Error Table for Chemistry Analytes
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Reference Range Requirements-Chemistry v.1.0
- Audit Reference: Verification of Performanance Specification -Suggested guideline on the requirements to perform reference range verification
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Sensitivity Requirements-Chemistry
- Audit reference - Verification of Performance Specification - Overview on how to perform sensitivity testing on chemistry test.
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Sensitivity Requirements-Chemistry Worksheet
- Audit reference - Verification of Performance Specification - Worksheet for performing sensitivity testing on chemistry testing.
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