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 | Coordinators |
Issue ISSUE-xxxxx submitted to Complaint Handling process |
Issue Initiator | ||
Coordinator submits Issue as a CAPA Request | New Task - Submit New Request | Coordinator |
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 Closes Complaint without review by Approve Closure team | Complaint COMPLAINT-xxxxx closed | Issue Initiator |
Coordinator initiates Approve Closure | New Task - Approve Closure | Approvers |
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 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
All approvers have signed off Approve Closure with no rejections | Complaint COMPLAINT-xxxxx closed | Issue Initiator |
Black Text = Task Notifications Red Text = Additional Process Notifications