4.2.2. Enhanced CAPA Effectiveness Tracking & Evaluation

To bolster the tracking and evaluation of CAPA effectiveness throughout the CAPA workflow, we have implemented the following enhancements:

1. Effectiveness Period Date Fields

We have added two new date fields — Eff. Start Date and Eff. End Date — to the New CAPA form. These fields allow users to specify the period during which the effectiveness check occurs, ensuring thorough assessment within the designated timeframe.

2. Effectiveness Evaluation Fields
   

We have also added two new fields — Effectiveness Files and Effectiveness Check Result — to the Check Effectiveness & Approve form. These fields allow users to document and communicate their evaluation findings, providing supporting evidence in the form of files or descriptive notes.

*These form additions enhance evaluation clarity and completeness, ensuring CAPAs meet intended objectives and driving continuous improvement.