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All of the web links and documents that are available on this site undergo a scheduled review for accuracy and relevance. The current documents and links were last reviewed in May 2020.

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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Coagulation

This folder includes templates for Validation Plan and Summary
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.

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