Design Files

Overview

Design Files are used to store documents and information that support product or process design. They help keep design materials organized, controlled, and traceable throughout quality and compliance activities.

• They hold the supporting files needed for design decisions.

• They keep revisions organized and easy to review.

• They ensure design information stays controlled and accessible.

Design Files help teams manage design information in a consistent and compliant way.

Additional Resources

ComplianceQuest

• Design File Creation & Setup

• Product & Process Definition

• Design Development

• RTM

• Risk & Failure Mode Effects Analysis

• Document & Master File Management

• Review & Approval

• Production

• Decommission

• Closure