Purpose

Corrective and Preventive Actions (CAPAs) are an integral process of any good Quality Management System (QMS). They are used to identify actions that may either correct an identified root cause or prevent that cause from happening. The objectives of tracking CAPAs are to provide a mechanism for minimizing risk of harm (fixing an existing root cause) or to drive continuous improvement, which is a cornerstone objective of QMSs as a whole.

This application provides a digital way to manage this process consistently so that you can spend your time focusing on improving your risk profile or QMS effectiveness as a whole. With all your data in digital format you can easily view historical and current records in order to evaluate and manage the effectiveness of your CAPA process and focus on continuous improvement.

***NOTE**** This application contains documentation to help you get up and running more quickly. Contact support@tulip.co for an Operational Flow Diagram, a Risk Assessment, and a Test Plan for a seamless GxP deployment.all your data in digital format you can easily view historical and current records in order to evaluate and manage the effectiveness of your CAPA process.

Overview

This applications works closely with the CAPAs table. Every time a new CAPA is submitted, it is entered into the table. The following metadata stored with each event at the conclusion of the entire workflow includes:

-Description

-Assignee

-Status

-Source ID

-Photo

-Created By

-Created Date

-Due Date

-Linked Quality Event

-Actions Taken

-Evidence of Completion (text)

-Evidence of Completion (photo)

-Root Cause Description

-Closed Date

-Duration

The application has a pre-defined workflow that guides an event through pre-configured screens in order to move the event through the following states:

-In Process

-In Review

-Cancel

-Closed

Installation Instructions

Click to Download

At each state change there is also a new Assignee assigned to the ticket. In order to configure and make this application your own you must update the logic to have it route to the appropriate Owner for your organization. In the App Editor make the following updates:

  1. Open the 'Investigation Report' step and click on 'Submit' button

  2. Click the pencil icon next to the 'Update Event' trigger and edit the action that updated the Assignee field.

    *Note*: Make sure users have set up their

Optional Modifications

Update/Change Status

If the status' we provided don't work for your organization, you can easily change them by modifying the triggers at each state change. Use this chart to locate the different state changes:

State Change

Step Name

Button Name

In Process

Report CAPA

Report CAPA

In Review

Investigation Report

Submit

Cancel

Edit CAPA

Cancel CAPA

In Process

Additional Info - Reject

Save

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