During the definition phase, development engineers focus on finalizing the design input requirements (DIR), so that the design can be frozen. As during previous phases, all other teams (research, development, regulatory, etc.) provide input. The design cannot be frozen until the entire cross-functional team signs off on it. As is also true during previous phases, there are an enormous number of documents that must be controlled and managed.
Discover how MasterControl software can manage your processes, all while mitigating risk, improving speed-to-market, and generating ROI.
Get in-depth, comprehensive resources to guide development of your programs and processes.
Get insider information about the most relevant issues, and how to navigate and overcome the complexities of FDA regulations.