Who receives notifications during the Issue/Complaint process?
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 | Issue Initiator | |
Coordinator closes Issue without further action | Issue ISSUE-xxxxx closed | Issue Initiator |
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|
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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 |
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|
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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 | |
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
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