Table of Contents

Overview

Control Methods are the analytical methods in the form of a series of steps to test and demonstrate an analytical procedure is suitable for its intended purpose. The methodology and objective of the analytical procedures should be clearly defined and understood before initiating validation studies.

QbDVision provides the capabilities to define and structure your product data and link your QTPP or Process Parameter to the corresponding Control Methods. Linked Control Methods will then be displayed in reports.

Video Tutorial

Key Concepts

Creating a Control Method

To create a Control Method, navigate to the Control tab and click the Add button. Name and populate the Control Method form with the appropriate information and click Save.

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Linking a Control Method

Once a Control Method has been created, it can be linked to appropriate project records. To link a Control Method to the applicable record, navigate to that record, click Edit, and select the Control Method from the dropdown options.

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Frequently Asked Questions

Why can’t I add my Control Method when creating a new Project record, e.g., an FQA? I tried to enter the name in the Control Method field, but it didn’t get saved.

The Control Method field is a dropdown field that allows you to select a Control Method from the Control tab. A Control Method must be created from the Control tab before it can be added to a Project record.