Coagulation
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SMILE Coagulation Validation Overview v.1.0
- Audit Reference - Verification of Performance Specification - Overview of what should be included in coagulation validation.
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Coagulation Validation Plan Template v.1.0
- Audit Reference - Verification of Performance Specification - Template for Coagulation validation.
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Coagulation Validation Summary Template v.1.0
- Audit Reference - Verification of Performance Specification - Template for Coagulation validation summary
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Precision Requirements-Coagulation v.1.0
- Audit Reference - Verification of Performance Specification - guideline for precision on coagulation validation.
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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
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Comparability Requirements Coagulation v. 1.0
- Audit Reference - Verification of Performance Specification - Guideline for Comparability testing for Coagulation validation.
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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.
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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.
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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.
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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.
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Reference Range Requirements-Coagulation v.1.0
- Audit Reference - Verification of Performance Specification - Guideline for reference range for Coagulation validation.
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