Document Control System
A Document Control system is required in all regulated industries. Any change to documents or the introduction of new document require processing through the document control system and the change control system.
Documents that are part of a change control are submitted to document control for their update, review, and approval. This activity may be a separate “action item” to implement these changes.
The completion of document changes is required for the change to be implemented and effective. Thus, the review and approval of the updated documents must be timed with the implementation of the change control if there are other actions needed.
If there are no other actions in the change control, then the implementation of the change control has the same as the timing as the effective document implemented for GMP use.