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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