There are four major documents related to new quality initiatives within pharmaceutical production.In order of release they are The PAT initiative,ICH Q8 Pharmaceutical Development,Process Validation and ICH Q11.MKS Umetrics has continuously discussed these documents with regulatory bodies and provide training to members of European Medicines Agency(EMA)and the Swedish,French,Dutch and German regulatory agencies within Design of Experiments(DOE)and Multivariate Data Analysis(MVDA).