Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...
The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation. The ...