Hi I have a question on change control if anyone can help. We currently have a separate procedure for our deviation system which currently handles our temporary changes and emergency planned deviations or changes. I am currently revising the change control system and some people on site argue that temporary changes and emergency changes should be handled by our change control system not within a deviation system.
The argument for the current set up is that it is linked to the change control system and CAPA system (activities or document changes required due to the deviation), the system is working (all emergency changes and temporary changes are raised and approval for the planned deviation is required from QA before it can be implemented (it even covers the procedure for if QA are not available).
The question therefore is this sufficient or should we be looking to incorporate these situations into change control?