TABLE 2.

Elements of a validation plan

Validation plan element(s)
Description of the scope, purpose, and intended application of the method
Description of the performance parameters of the method that will be tested and the data that will be accumulated
Plan for testing those parameters, including:
Critical reagents and equipment needed
Standard reference materials needed, including positive and negative controls and the ranges of those conditions to be evaluated
Validation of test samples in a no. of replicates sufficient to demonstrate reproducibility and reliability
Conditions and ranges of conditions to be tested
Any aspects unique to the system that require additional specific testing
End results to be assessed, any statistical analysis that will be performed, and criteria for interpretation
Any special personal protective equipment, safety equipment, or safety practices required to perform the method safely
Requirements for personnel performing the method, such as training and competency
Interpretation of results of the analysis according to the interpretation criteria developed above (see the fourth item above)