Several email notifications are sent during the Issue and Complaint processes. The table below summarizes the activities that generate notifications, the content of those notifications, and the notification recipients.
Action | Email Notification | Recipient(s) |
Initiator submits Issue | New Task - Review New Issue | Coordinators |
Coordinator returns Issue for additional information | New Task - Submit New Issue (includes signoff comments from Coordinator) | Issue Initiator |
Coordinator submits Issue as a Complaint | New Task - Initiate Complaint Issue ISSUE-xxxxx submitted to Complaint Handling process | Coordinators Issue Initiator |
Coordinator submits Issue as a CAPA Request | New Task - Submit New Request Issue ISSUE-xxxxx submitted to CAPA process | Coordinator Issue Initiator |
Coordinator closes Issue without further action | Issue ISSUE-xxxxx closed | Issue Initiator |
A user signs off on a Research Complaint task | <user> has completed a task Research Complaint for COMPLAINT-xxxxx | Investigator |
A user signs off on the Investigate task | User <user> has completed the Investigate task for COMPLAINT-xxxxx | User performing Initiate Complaint task |
Coordinator cancels Approve Closure | New Task - Review for Closure | Coordinator |
Complaint COMPLAINT-xxxxx canceled by <user> | Approvers with closed Approve Closure tasks | |
Closed Task - Approve Closure (includes coordinator signoff comments) | Approvers with open Approve Closure tasks | |
An individual approver approves Approve Closure | None | N/A |
An individual approver rejects Approve Closure | Complaint COMPLAINT-xxxxx rejected by <user> (includes approver signoff comments) | Coordinator |
All approvers have signed off Approve Closure after one or more approvers have rejected | New Task - Review for Closure | Coordinator |
Complaint COMPLAINT-xxxxx rejected | Approvers | |
Complaint Closes | Complaint COMPLAINT-xxxxx closed | Issue Initiator |
Originator submits DCR | New Task - Preliminary Coordinator Review | Coordinator |
Coordinator rejects Preliminary Coordinator Review | New Task - Submit New Request (includes coordinator signoff comments) | Originator |
Coordinator approves Preliminary Coordinator review | Change Request DCR-xxxxx submitted for Formal Review | Originator |
New Task - Formal Review | Approvers | |
Coordinator cancels Formal Review | New Task - Preliminary Coordinator Review | Coordinator |
Change Request DCR-xxxxx canceled by <user> “The Formal Review for this Change Request was canceled by a Document Control Coordinator. Review and address any comments.” | Originator | |
Closed Task - Formal Review (includes coordinator signoff comments) | Approvers | |
An individual approver approves Formal Review | None | N/A |
An individual approver rejects Formal Review | Change Request DCR-xxxxx rejected by <user> (includes approver signoff comments) | Coordinator Originator |
All approvers have signed off Formal Review after one or more approvers have rejected the DCR | New Task - Preliminary Coordinator Review | Coordinator |
Change Request DCR-xxxxx rejected | Originator Approvers | |
All approvers have signed off Formal Review after approving the DCR | New Task - Release Documents | Coordinator |
Change Request DCR-xxxxx approved | Originator | |
Coordinator Rejects DCR at Release | Change Request DCR-xxxxx rejected by <user> (includes coordinator signoff comments) | Originator Approvers |
New Task - Preliminary Coordinator Review | Coordinator | |
Coordinator Releases DCR | Change Request DCR-xxxxx has been released | Originator |
Complaint Closes | Complaint COMPLAINT-xxxxx closed | Issue Initiator |
Black Text = Task Notifications Red Text = Additional Process Notifications