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SMILE Validation Guidelines and Templates

SMILE Comments: These documents are provided as examples only. They 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. If you have any questions contact your SMILE representative.
Hematology Validation for VTN
This folder contains all the basic tools you will need to validate a hematology instrument. Start with the Quantitative Overview document to understand the steps required for validation. This will refer you to other more detail information contained in the other documents.
Related Items Stored in Other Folders
File Microsoft Word Document Quantitative Validation Overview v.1.0
Audit Reference: Verification of Performance Specifications - Guideline for Quantitative Validation
File Microsoft Word Document Qualitative Validation Overview v.1.2
Audit Reference - Verification of Performance Specification - Guideline for Qualitative Validation
File Microsoft Word Document SMILE Definition of Statistical Terms v. 1.0
Audit Reference - Verification of Performance Specification - statistical formulas.
File Microsoft Excel spreadsheet SMILE Performance Criteria for DAIDS Analytes v.1.3
Audit Reference - Verification of Performance Specification - Excel sheet listing Total Error for Quantitative tests.
File Microsoft Word Document Lineamientos de validación cuantitativa
Audit reference - Verification of Performance Specification - Spanish version of Quantitative Validation Overview
File Microsoft Word Document Lineamientos de validación cualitativa
Audit reference - Verification of Performance Specification - Spanish version of Qualitative Validation Overview
File Microsoft Word Document Qualitative Validation Summary Template v1.2
Audit Reference - Verification of Performance Specification - An example of a validation summary template for Qualitative testing methods.
File Microsoft Word Document Qualitative Validation Plan Template 1.1
Audit Reference - Verification of Performance Specification
File application/x-ica Plano Validação Bioquímica.
Audit Reference - Verification of Performance Specifications - Chemistry validation plan in Portuguese
Chemistry
This folder includes templates for Validation Plan and Summary
Hematology
This folder includes templates for Validation Plan and Summary
Coagulation
This folder includes templates for Validation Plan and Summary
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.
HIV (EIA)
This folder includes Validation Overview and templates for Validation Plan and Summary
Other Waived Test (Non HIV)
This folder includes Validation Overview and template for Validation Summary.
Rapid HIV
This folder includes Validation Overview and template for Validation Summary
Qualitative Immunoassay (Other Viral Markers)
This folder includes Validation Overview and templates for Validation Plan and Summary
Carryover
Interference
Audit Reference - Verification of Performance Specification
Western Blot (HIV)
This folder includes templates for Validation Plan and Summary
Mycobacteriology
This folder includes templates for Validation Plan and Summary
Syphilis
This folder includes Validation Overview and templates for Validation Plan and Summary

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