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Coagulation

This folder includes templates for Validation Plan and Summary
File text/texmacs Coagulation Specimen Requirements
Audit Reference - Verification of Performance Specification Document for specimen requirement for coagulation testing.
File Microsoft Word Document SMILE Coagulation Validation Overview v.1.0
Audit Reference - Verification of Performance Specification - Overview of what should be included in coagulation validation.
File Microsoft Word Document Coagulation Validation Plan Template v.1.0
Audit Reference - Verification of Performance Specification - Template for Coagulation validation.
File Microsoft Word Document Coagulation Validation Summary Template v.1.0
Audit Reference - Verification of Performance Specification - Template for Coagulation validation summary
File Microsoft Word Document Precision Requirements-Coagulation v.1.0
Audit Reference - Verification of Performance Specification - guideline for precision on coagulation validation.
File PDF document SMILE Precision Requirement Appendix 1 Coagulation TE Table v.1.1
Audit Reference - Verification of Performance Specification - Table with Total allowable Error for Coagulation validation
File Microsoft Word Document Comparability Requirements Coagulation v. 1.0
Audit Reference - Verification of Performance Specification - Guideline for Comparability testing for Coagulation validation.
File PDF document SMILE Comparability Requirements Coagulation Appendix 2 TE Table v.1.1
Audit Reference - Verification of Performance Specification - Table with Total allowable Error for Coagulation validation testing.
File PDF document Smile Comparability Requirements Coagulation Appendix 3 Two Instrument Comparison Example Report v.1.0
Audit Reference - Verification of Performance Specification - Example of report for two instrument comparison.
File PDF document Smile Comparability Requirements Coagualtion Appendix 4 Alternate Method Comparison Example Report v.1.0
Audit Reference - Verification of Performance Specification - Example report of alternate method comparison.
File PDF document Smile Comparability Requirements Coagulation Appendix 6 Six Sigma Example Report v.1.0
Audit Reference - Verification of Performance Specification - Example of a report using 6 sigma comparson.
File Microsoft Word Document Reference Range Requirements-Coagulation v.1.0
Audit Reference - Verification of Performance Specification - Guideline for reference range for Coagulation validation.
File INR Verfication Overview
Audit reference - Test Method Validation and Verification Document explaining INR verification of new instruments and lot numbers
File INR Verification Plan Template
Audit reference - Test Method Validation and Verification Template for INR verification of new instruments and lot numbers
File INR Verification Summary Template
Audit Reference Test Method Validation and Verification INR Verification Summary Template
File Troff document INR Calculation Worksheet
Audit Reference - Test Method Validation and Verification An Excel tool that calculates Geometric mean and INR Verification Calculator

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