Complaint Properties

This page displays the details of complaint, tasks associated with the complaint, and list of events associated with the complaint.

To access this page:

From the Complaints page, click the name of the required complaint.

This topic describes:

This page discusses:

Properties
Tasks
Events
Categories

Properties

Fields


Section Name	Field Name	Description
	Owner	Name of the complaint owner
	Originator	Name of the complaint originator
	Receipt Date	Date when the complaint was raised
	Modification Date	Date when the complaint was last modified
	Awareness Date	Date when the problem was identified
	Status	State of the complaint. Possible states are Create, In Process, Closed, and Invalid.
	Distributor Awareness Date	Date when the problem was identified by the distributor
	Complaint Handling Unit	Name of the company that handles the complaint
	Source	Communication method through which the complaint was raised
	Customer Severity	Severity level of the complaint
	Country Of Origin	Country in which the problem was identified
	Investigation Required	Yes, if evaluation is required for the complaint No, if evaluation is not required for the complaint
	Purchase Order	Purchase order number related to the product
	Additional Information	Additional information about the complaint
	Reassign Rationale	Reason provided when the complaint was reassigned
	Type Change Justification	Reason provided when the complaint was converted to equipment service request or inquiry
	Litigation	Litigation information related to the complaint
	Reportable	Reportable status of the event
	Require Regulatory Analysis	Yes, if regulatory analysis is required No, if regulatory analysis is not required
Invalidation Details	Rationale	Reason provided when the complaint was invalidated
	Name	Name of the invalidator
	Date	Date when the complaint was invalidated
Closure Details	Closed Rationale	Reason provided when the complaint was closed
	Closed Date	Date when the complaint was closed
	Customer Closure Date	Date when the complaint was closed by customer
Reopen Details	Count	Number of times the complaint was reopened
Reopen Details	Reopen Rationale	Reason provided when the complaint was reopened

Actions


Action	Description	For More Information
Actions > Summary Report	Generates a complaint summary report	Summary Report

Tasks

For more information, see Tasks.

Events

Columns


Column Name	Description
Name	Name of the complaint and the event. The name of the event is prefixed with CPTEVT.
Type	Object type, complaint event
Experience Code	Experience code, which is used to classify the problem
Issue Code	Issue code, which is used to classify the issue
Date of Occurrence	Date on which the problem occurred
Received Date	Date on which the problem was reported
Primary	: event is the primary event
Confirmed	: event is confirmed
Timing	Process during which the problem was identified. Shows FDA codes for timing. Possible values are: Kit Inspection Other Unknown Upon Receipt
Patient	: patient is associated with the event. Point to view details such as date of birth, age at the time of occurrence of the problem, gender, and weight. Click to view the details of the patient.
Reportable	: event is reportable
Problem Description	Description of the problem

Actions


Action	Description	For More Information
Run Decision Tree	Lets you create an Adverse Event Report using the decision tree.	Run Decision Tree

Categories


Category Name	Description	For More Information
Contacts	Lists contacts associated with the complaint	Contacts Page
Correspondences	Lists correspondence associated with the complaint	Correspondence List
Assignees	Lists regulatory people who have regulatory access on the complaint
Product Evaluation	Lists evaluation performed on the complaint	Product Evaluations
Adverse Event Reports	Lists adverse event reports associated with the complaint	Adverse Event Reports
Reference Documents	Lists documents related to the complaint	See Managing Documents in the Business Process Services - Common User's Guide
Discussions	Lists discussions related to the complaint	See Working with Discussions in the Business Process Services - Common User's Guide
Lifecycle	Displays the lifecycle of the complaint	About complaint lifecycle, see Content Lifecycles About lifecycles, see Working with Lifecycles in the Business Process Services - AEF User's Guide
Related Items	Lists objects related to the complaint	See Related Items List.
History	Displays complaint history	See History.
Where Used	Lists complaint usage	See Where Used/Related Page in the Business Process Services - Common User's Guide
Related CAPA	Shows related CAPA projects and CAPA requests.	See Related CAPA Page.