Overview
As a best practice in ComplianceQuest, always begin by creating a Design File record for your product or project.
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Users with CQ Base User PSG, CQ Design Owner PSG, and CQ Design Team Member PSG are authorized to create and manage Design Files (for example, Design Owners or designated Design Team Members) with permissions granted by your CQ Administrator.
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The Design File serves as the central source and parent record, ensuring that all related child records such as FMEAs, Product Risk, Requirements Traceability Matrix (RTM) and Control Plan are properly linked and managed.
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This approach supports full traceability, regulatory compliance, and efficient collaboration, as all child records are created from and associated with the Design File, forming a complete and auditable documentation structure.
Additional Resources
Refer the below links for navigating to the next steps.
ComplianceQuest
Create Design File: Create a Design File to compile and organize all the Design elements.
Manage Team Members: Assign team members and define their roles for collaboration and accountability