T
Turquoise202
Hi, I have a question regarding two of FDA's design and development planning requirements.
FDA lists the elements that would be typically addressed in the design and development plan, and ends the list with the following:
· Controls for design documentation
· Notification activities.
I assume that controls for design documentation is simply providing information on how the company plans to control the design documents, such as revision history, coding/numbering system and signed approvals?
I can't really understand what "notification activities" refer to. Would really love your help here.
Thanks in advance!
FDA lists the elements that would be typically addressed in the design and development plan, and ends the list with the following:
· Controls for design documentation
· Notification activities.
I assume that controls for design documentation is simply providing information on how the company plans to control the design documents, such as revision history, coding/numbering system and signed approvals?
I can't really understand what "notification activities" refer to. Would really love your help here.
Thanks in advance!