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 | |||
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 | ||||
All approvers have signed off Approve Closure with no rejections | Complaint COMPLAINT-xxxxx closed | Issue Initiator | Coordinator Closes Complaint without review by Approve Closure team | Complaint COMPLAINT-xxxxx closed | Issue Initiator |
Black Text = Task Notifications Red Text = Additional Process Notifications