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When the DCR is released, the system creates a task to monitor the effectivity conditions and mark the previous document revision as superseded when they expireno longer apply.
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Once a document revision is superseded, it cannot be made effective again. |
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The effective revision for an Instructions for Use (IFU) document is A.
Health Canada requires a change to the IFU for product distributed in Canada, but that change has not yet been approved by the FDA for shipments within the United States. Therefore, the DCR specifies that both revision A and the new revision must be effective at the same time.
After the DCR is approved, a document coordinator releases the documents and assigns the regulatory department a task to mark revision A as superseded once revision B has been approved by the FDA.
A member of the regulatory department has the task to mark revision A of the IFU as superseded when the effectivity conditions no longer apply.
Revisions A and B of the document are both effective.
Once the FDA approves revision B of the IFU, the assigned user marks revision A as superseded.
Revision A is superseded and revision B is effective.
