Validate - Routine
Assesses assay performance for quantitative, semi-quantitative and qualitative assays
The original and most popular package designed for most laboratories to meet standard 5.5.1 of ISO15189:2012.
This package facilitates the preparation of validation and/or verification reports for laboratory developed methods or commercial applications for quantitative, semi-quantitative or qualitative assays which can be performed either manually or using routine analysers.
Suitable for clinical and research use the templates will adapt to the qualification process depending upon whether an assay is used as described or whether modifications have been necessary for a particular sample type.
Validate - HPLC
Assesses assay performance for quantitative, semi-quantitative and qualitative assays
This package facilitates the preparation of validation and/or verification reports for any assay whether quantitative, semi-quantitative or qualitative performed using HPLC.
In addition as part of the assessment of the assay imprecision the measurement of uncertainty and total allowable error will be calculated and the robustness of the assay will be assessed.
Suitable for clinical and research use the templates will adapt to the qualification process depending upon whether an assay is used as described or whether modifications have been necessary for a particular sample type. Suitable for the assessment of assay performance using any manufacturers HPLC system.