CAPA Lite by PCG

Start satisfying your requirements for Corrective Action and Preventive Action or create a more disciplined, structured approach to your Continuous Improvement Program, even if not in a regulated environment.

Purpose

This basic CAPA Lite enables the User to:

• Create a Quality Event
• Manage Quality Events
• Investigate Root Cause
• Review all Quality Event Activity
• Summarize CAPA activity with a dynamic dashboard

Functionality Overview

• App opens to the CAPA Status Page, essentially a Dashboard, detailing various KPI's based on all Quality Events. Review the appropriate Status, Category, or Priority Metrics
• The Manage Events Button takes the User to the Quality Events Master List
• Filters make it easy for the User to select the desired Status, Category, or Owner for their review
• To create a new event, the Reporter completes the Description, selects a Category and Priority, adds a image (optional) and selects New…the Quality Event immediately appears in the list
• To initiate an investigation, a User selects the Event and upon entry of any investigative notes, becomes the initial Owner
• Owners can record as many investigative notes as needed. Each note can support an image or reference
• Owners can update an Event at any time, updates immediately render in the List on and in the CAPA Status Dashboard
• Owners can also reassign an Event should they find the ongoing investigation requires different resources
• Dispositions are created to support the company CAPA SOP
• Once satisfied that the Event has been thoroughly investigated, the Owner can determine the Disposition and close the event
• All investigate notes and images can be accessed via the Review Button exposed when an Event, Active or Closed, is selected

Recommendations

• This CAPA Lite App is designed to help you get started with CAPA or Continuous Improvement. Once you are acclimated to the functionality and need broader features, there are two upgrade paths:
• PCG can support expanding theis App to better model your actual, possibly evolving, CAPA SOP’s
• This basic App can be expanded and upgraded into a more comprehensive CAPA App with the ability to support Compliance requirements and Auditing with PCG’s SmartFactory Suite of Apps (see https://asmartfactory.com).
• Beyond Quality, Compliance, and CAPA, SmartFactory is designed to support Manufacturing Execution with a breadth of pre-built, ready to use functionality
• If you are in a regulated environment, Tulip’s Regulated Industry Account is highly recommended