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All documents are intended as examples and must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications.

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Validation Tools

Folder contains excel spreadsheets for Quantitative Validation which includes the Accuracy Pack, Accuracy Requirement Error Index Calculator, Linearity Requirement Tool, Reference Range Sample Questionaire, and Reference Range Requirment Pack.
File Microsoft Excel spreadsheet SMILE Accuracy Appendix 1 SMILE Accuracy pack Tool v.1.1
Audit reference: Verification of Performance Specificaitons - Excel worksheets for performing Accuracy Validation, includes Two method comparison, Alternative Method comparision and Sigma metric.
File Microsoft Excel spreadsheet SMILE Accuracy Appendix 5 SMILE Error Index Calculator Tool v.1.0
Audit reference: Verification of Specification - Excel worksheet to calculate error index for Accuracy validation.
File Microsoft Excel spreadsheet SMILE Linearity Appendix 1 SMILE Linearity Tool v.1.1
Audit reference: Verification of Performance Specifications - Excel worksheet to use in linearity validation.
File Microsoft Word Document SMILE Reference Range Appendix 1 Sample Health Questionnaire v2.0
Audit Reference: Verification of Performance Specification - Example of questionnaire that can be given to volunteer for reference range validation for screening.
File Microsoft Excel spreadsheet SMILE Reference Range Appendix 2 Reference Interval Analysis Tool v.1.0
Audit Reference: Verification of Performance Specification - Excel worksheet to verify reference range

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