10. CAPA List

In this module, users can access a list of all CAPAs created using the application.

Search Panel

All fields inside the search panel act as search boxes. Any value inputted inside them will be used as search criteria to filter and retrieve data from the grid, if possible.

*For more guidance on how to utilize single-select dropdown fields, click here

1. CAPA ID: This is a text field that allows users to filter by CAPA ID.
2. CAPA Name: This is a text field that allows users to filter by the name of the CAPA.
3. Event Type: This is a single-select dropdown field that allows users to filter by event type.
4. Business Division: This is a single-select dropdown field that allows users to filter by business division.
5. Business Line: This is a single-select dropdown field that allows users to filter by business line.
6. Filter: This button filters the results according to the entered search criteria.
7. Clear Filter: This button clears the filters that were used in the previous search and allows users to again view the full data set.

Grid

Inside the grid, CAPAs are organized by values derived from the CAPA workflow.

• View ( ): This button allows users to view a CAPA.
  • In viewing mode, users cannot make any modifications. They can, however, download attached files, view details in supplemental forms, and access/download any available templates.

!When a CAPA is triggered from the Audit application, its ID will be unique but not sequential to the ID created when a CAPA is triggered independently or from the Quality Event application. For example, if the CAPA is created independently, its ID will take the next available value (max ID +1). It will not, however, follow the sequence for CAPAs created in the Audit application.

Status Tracker – Feature Highlights

The Status Tracker column provides visibility into the phases of issue escalation across various QMS applications, including Audit, Quality Event (QE), CAPA, and Incident.

The column displays:

• Origin of Escalation: Indicates where the issue started (e.g., Audit, QE, or Incident).
• Destination of Escalation: Indicates where the issue has been escalated to (e.g., CAPA).
• Current Phase: Indicates the current phase of the issue within the escalated application.
• Associated IDs: Provides relevant IDs for quick reference, such as Audit ID or CAPA ID.
  
  

  *In terms of terminology, issues are sourced from Audit, escalated from QE and Incident, and escalated to other applications such as CAPA.

  ** The Status Tracker column updates in real-time as issues are escalated, ensuring that information remains current.

  
  

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To simplify tracking, the Status Tracker consolidates workflow stages from the Incident, QE, and CAPA applications into broader phases, allowing users to grasp the overall progress without being overwhelmed by granular details.

The table below outlines each application’s workflow stages and the phases they fall under in the Status Tracker:

Incident Phases	Incident Stages	QE Phases	QE Stages	CAPA Phases	CAPA Stages
Investigating Incident	Create New Incident; Review Incident Report; Modify Incident Report	Analyzing Issue	Review the Issue; Modify Quality Event; Gather Details	Evaluating CAPA (RCA)	Review CAPA; Modify CAPA (1); Execute Root Cause Analysis; Verify CAPA; Modify CAPA (2)
Execute Action	Execute the Action	Containment	Contain/Correct Issue	Execute Action	Execute the Action
Reviewing Incident Resolution	Check Effectiveness & Approve Report	Analyzing if CAPA Needed	Review the Issue – Needs CAPA?	Reviewing CAPA Resolution	Check Effectiveness & Approve
N/A	Issue Escalated to QE or CAPA	N/A	Send to CAPA (QE Closed)	CAPA Sign Off	Sign Off
		Execute Action	Execute the Action	CAPA Closed	CAPA Closed
		Reviewing QE Resolution	Check Issue Correction
		QE Closed	Issue is Contained; No Issue

*To access additional options or perform actions related to the grid, please utilize the kebab menu ( ) located in the upper rightmost corner.