CAPA Request Process Steps

Color	Description
Green	Completed steps.
Blue	Current or active steps. You can perform actions on this.
Grey	Future steps.
Red	Stopped steps. These are steps where the process flow is blocked.

As you hover the pointer over the step circle, the border color of the circle becomes bold and it can be clicked. You can also use the Expand option to view the details of steps. When the step circle is clicked, the tasks for the step are loaded in a table. You can initiate and complete CAPA request process from the task table. You can perform required tasks under Actions column based on your role.

Process Steps	Step Description	CAPA Request State
Initiate	Capture details to initiate CAPA request.	Preliminary
Evaluate	Assign and evaluate request.	Requested, Review
Rejected	CAPA request is not approved. This step is visible only if the CAPA goes to the Not Approved state.	Not Approved
Initiate CAPA Project	Capture details to initiate the CAPA project.	Approved
Complete	Committed and fulfilled CAPA request	Committed, Fulfilled

When the step circle is clicked, the tasks for the step are loaded in a table below. You can initiate and complete CAPA request process from the table. You can perform required tasks under Actions column based on your role. After completing the action, the task is validated as true and the task icon turns green.

An icon shows the status of each process step task:

Icon	Process Step Task Status
	Status shows the tasks are optional.
	Status shows the tasks are mandatory and are not yet completed.
	Status shows the tasks are completed and are validated as true.

Task Title	Task Type	Role	Owner	Actions	Related Data
Review comments and provide the required info before re-submit (This task is only visible if CAPA request has been sent back for need information at least once.)	Optional (This task is only visible if CAPA request has been sent back for need information at least once.)	_	CAPA Request Owner	Click icon to view the comments.	-
Identify Input Data Sources	Mandatory	_	CAPA Request Owner	Click icon to add data sources.	Click icon to open data sources table.
Identify Items Impacted by Change	Optional		CAPA Request Owner	Click icon to add related items.	Click icon to add related items.
Add Supporting Documents	Optional	_	CAPA Request Owner	Drop documents on the Drop icon to add reference documents. Click Add Existing to add the existing refrence documents.	Click Related Data icon to view the added documents.
Submit for Evaluation	Mandatory	_	CAPA Request Owner	Click icon to submit for evaluation. The Submit for Review form is opened. You can needs to select the required field values and submit the request.	-

Task Title	Task Type	Role	Owner	Actions	Related Data
Accept CAPA Request responsibility	Mandatory	Quality Manager	CAPA Request Owner	Click icon to accept the CAPA request responsibility. A Quality Manager can accept the CAPA request.	_
Change Assignment to perform Evaluation	Optional	Quality Manager	CAPA Request Owner	Click icon to change assignment to perform evaluation.	_
Request for more information from Originator	Optional	Quality Manager	CAPA Request Owner	Click icon to request for more information from originator.	Click icon to view CAPA request name.
Add Supporting Documents	Optional	Quality Manager	CAPA Request Owner	Drop documents on the Drop icon to add reference documents. Click Add Existing to add the existing refrence documents.	Click Related Data icon to view the added documents.
Mark Request as Duplicate	Optional	Quality Manager	CAPA Request Owner	Click icon to set the CAPA request as duplicate. The Search page is opened to select the master CAPA request.	_
All the Route tasks will be displayed	Mandatory	-	Owner of the inbox task	Click icon to accept or reject task or edit comments. You can provide comments and then complete route task.	Click icon to open the route properties.

Task Title	Task Type	Role	Owner	Actions	Related Data
CAPA Request Not Approved	Mandatory	_	CAPA Request Owner	No actions, as this is the end of CAPA request lifecycle after it is in the Not Approved state.	_

Task Title	Task Type	Role	Owner	Actions	Related Data
Assign Project Lead for CAPA Project Initiation	Optional	Quality Manager	CAPA Request Owner	Click icon to change the owner of the CAPA Request.	_
Start the CAPA Project	Mandatory	Project Lead	CAPA Request Owner	Click the Create CAPA icon to create a CAPA or click the Associate CAPA icon to associate to an existing CAPA.	CAPA icon gets displayed after CAPA is connected to the CAPA request. Click the icon to view the CAPA details.

Task Title	Task Type	Role	Owner	Actions	Related Data
CAPA Project is being executed This task is visible only when CAPA Request is in the Committed state.	Mandatory	_	CAPA Request Owner	No action required. After associated CAPA is completed, the CAPA request is automatically promoted to the Fulfilled state. Then this task will become invisible.	CAPA icon gets displayed after CAPA is connected to the CAPA request. Click the icon to view the CAPA details.
CAPA Project is completed This task is visible only when CAPA Request is in the Fulfilled state.	Mandatory	_	CAPA Request Owner	No actions. By default, this task is set to true.	_

This panel is visible only if the CAPA Request or its connected CAPA requests have at least one data source.

Column Title	Description
Name	Name of the data source. Hyperlink provided to navigate to the data source.
Type	Type of the data source.
Status	Current lifecycle state of the data source.
Impacted Items	Owner of the data source.
Owner	Owner of the data source.
Description	Description on the data source.

This panel shows the CAPA connected to the CAPA request.

Column Title	Description
Name	Name of the CAPA. Hyperlink is provided to navigate to the object.
Type	Type of the CAPA.
Status	Current lifecycle state of the CAPA.
Severity	Severity of the CAPA.
Owner	Owner of the CAPA.
Title	Title of the CAPA.