Design Controls and Development: DHF

Coordinate project activities and NPI tasks to ensure completion of design control deliverables and automatically populate the resulting Design History File (DHF)

All companies are faced with ever-shrinking product lifecycles in order to timely satisfy the diverging needs of global markets. This has resulted in an increase number of concurrent product development programs, which necessitates adoption of concurrent engineering methods.

However, this also increases complexity due to the parallel activity of various functional teams. Coordinating the various functional teams to prevent overloaded resources and bottlenecks is critical for optimizing cycle time. This becomes even more challenging in the life sciences industry where compliance with government regulations is mandatory. 

Design Controls and Development: DHF manages new product development design projects, activities and content with creation of the device design history file (DHF) to satisfy regulatory standards and good manufacturing practices for design control. Companies can provide global teams with the accurate, real-time design information they need to keep design projects on track in response to ever-shrinking product lifecycles.  The solution also provides management with real-time visibility into a design project’s status in terms of overall schedule, phases, gates, and resources.