MasterControl Validation Strategy FAQ

About This Document

Project management is important for businesses of any size or type, but it is particularly critical for life science companies because of the tremendous pressure they face in complying with global regulations. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Health, Labour and Welfare (MHLW) in Japan expect companies under their jurisdictions to have a formal project management plan that addresses relevant requirements, design control, and change control, among other things.