A robust, well-validated method will greatly reduce the need for laboratory investigations (due to invalid results). Robustness studies will test the parameters of all key steps in the analysis. Robustness studies will direct the incorporation of the best system suitability/control test into the analysis, through both the method and system robustness. These templates will help ensure a compliant and well-validated method.
Download the accompanying presentation, "Executing Effective Analytical Method Validations," presented at IVT's 16th Annual Validation Week, Philadelphia, PA, October 2010.