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

 

 

 

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

Black Text = Task Notifications       Red Text = Additional Process Notifications

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