AQbD is recommended by the International Council for Harmonization (ICH) to emphasize rigorous scientific foundation and risk assessment in the development of analytical methods. It comprises a comprehensive evaluation of the analytical conditions without relying on an operator’s experience or intuition. Using a systematic "Design of Experiment" (DoE) approach, significantly reduces the time and effort required for method optimization. From a specified set of initial experiments, LabSolutions MD visualizes the factor-response relationship and allows identification of optimum separation conditions at a glance. Computer simulation of chromatograms offers valuable information with regards to method robustness.

It is important to validate the robustness of the chosen conditions to evaluate how small changes
will affect the chromatographic result, and to ensure reliability of the analytical method. Iterative experimental design automatically generates a batch table for analyzing a small range of variations in each of the parameters that are determined to have a distinct effect on the separation, such as % organic modifier or oven temperature. The resulting chromatograms show whether the chosen variations result in acceptable (or any) changes in retention of the analytes.