Site map
An overview of the available content on this site. Keep the pointer still over an item for a few seconds to get its description.
- Welcome to Project pSMILE!
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Resources
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GCLP Related Documents
- Example Training Attendance Log
- Example Signature Sheet
- Example SOP Format
- Example Levey-Jennings (L-J) Charts
- Example Quality Control (QC) Log
- Example Reportable Range Experiments (Linearity)
- Example Analytical Sensitivity Experiments
- Example Precision Experiments
- Example Accuracy Experiments
- Example Reference Range Determination
- Example Laboratory Test Method List
- Example Quality Management Plan
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DAIDS GCLP Guidelines
- DAIDS_GCLP_Standards_v.4.1.pdf
- DAIDS_GCLP_Standards_v.4.1_French.pdf
- DAIDS_GCLP_Standards_v.4.1_Spanish.pdf
- DAIDS_GCLP_Standards_v.4.1_Thai.pdf
- DAIDS_GCLP_Standards_v.4.1_Vietnamese.pdf
- DAIDS_GCLP_Standards_v.4.1_Portuguese.pdf
- TB Lab Audit Checklist.pdf
- Central Lab Audit Checklist.pdf
- General Lab Audit Checklist.pdf
- PBMC Lab Audit Checkist.pdf
- Specimen Repository Audit Checklist.pdf
- Organization and Personnel
- pSMILE Website User Guide
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Equipment
- Time (NIST) web link
- General Laboratory Equipment Maintenance.docx
- Laboratory Equipment Maintenance Log.xlsx
- Temperature Monitoring Guidelines and SOP Example.docx
- Analytical Balance Maintenance and Calibration Guidelines and SOP Template.docx
- Analytical Balance Daily Annual Maintenance and Calibration Logs.xlsx
- Centrifuge Calibration Verification SOP.docx
- Centrifuge Calibration Verification Record Sheet.xlsx
- Correlation Testing for Quantitative Assays.pdf
- Correlation Testing Worksheet.xlsx
- Pipette Calibration SOP.docx
- Pipette Calibration Worksheet.xlsx
- Timer Calibration Verification Log.xlsx
- Timer Verification Record Sheet.xlsx
- Timer Calibration Verification SOP.docx
- Testing Facility Operation
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Test and Control
- Qualitative QC Log_Example.doc
- Quantitative QC Log_Example.doc
- Levey Jennings Chart_Example.xlsx
- Parallel Testing and Reagent Lot Validation Guidelines.pdf
- Establishing Quantitative QC Ranges.pdf
- Example of a Qualitative Reagent Lot Parallel Testing Form.docx
- Example of a PT or PTT Reagent Lot Parallel Testing Form.docx
- Example of a Hematology Reagent Lot Parallel Testing Form.docx
- Example of a Chemistry Reagent Lot Parallel Testing Form.docx
- Test Method Validation and Verification
- Records and Reports
- Physical Facilities
- Specimen Transport and Management
- Personnel Safety
- Laboratory Information Systems
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Quality Management
- pSMILE Investigation Reports
- Quality Management Plan (BHHRL) Example.pdf
- CLSI Guidelines for Developing a Quality Management Plan.pdf
- QSE 1 - Organization and Leadership.pdf
- QSE 2 - Customer Focus.pdf
- QSE 3 - Facilities and Safety Management.pdf
- QSE 4 - Personnel Management.pdf
- QSE 5 - Supplier and Inventory Management.pdf
- QSE 6 - Equipment Management.pdf
- QSE 7 - Process Management.pdf
- QSE 8 - Documents and Records Management.pdf
- QSE 9 - Information Management.pdf
- QSE 10 - Nonconforming Event Management.pdf
- QSE 11 - Assessment.pdf
- QSE 12 - Continual Improvement.pdf
- pSMILE HIV EQA Handout
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GCLP Related Documents