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Validation & Verification (Performance Parameters used to determine if…
Validation & Verification
Performance Parameters used to determine if a method is fit
Repeatability:
precision
Reproducibility:
can the results be reproduced
Trueness:
how close to the value
Selectivity:
the accuracy of its measurement
Sensitivity:
rate of change of a response against the conc
Accuracy
Precision
Ruggedness:
the degree to which the results are unaffected by minor change
LOD
Range in which the calibration equation replies
Matrix Effects
Three types of test methods
Standard Methods:
published by international or national standards (Standard Australia or ISO)
Require verification
Published Methods:
Methods developed by individual scientists, and published in peer reviewed scientific journals. Methods are published by a manufacturer.
require verification
In-house or Laboratory developed methods:
developed by the laboratory itself to suit its own particular needs.
require validation
Validation:
is the process of assessing the ability of a method to obtain a result, determine the conditions under which results can be obtained, determine the limitations, find any critical aspects that must be maintained.
Must happen prior to the introduction of the method
Verification:
is the process of assessing the lab's capability to perform a Standard method against the documented performance characteristics. Also applies to published methods. Ensures the competence of laboratory staff.
Standards & Technical Notes that guide
17025:
laboratory must validate non-standard methods, their intended scope, amplification and modification of standard methods and if they are fit for use
FAD:
identify critical aspects, may be validated by comparison to other methods, validation must be conducted by the scientific community, records must be avaliable.
Technical Note 17:
validation must identify critical aspects of a procedure which must be carefully controlled. Must be validated by comparison, and against materials of known characteristics.