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Trace Matrix

The Trace Matrix module ensures complete traceability between User Needs, Design Inputs, Design Outputs, and Verification activities.

Dashboard Overview​

The dashboard provides a tabular view of all trace items, allowing for quick auditing and gap analysis.

Trace Matrix Dashboard

Key Columns​

  • User Need: The high-level requirement or need expressed by the user.
  • Source of User Need: Origin of the requirement (e.g., Risk Analysis, Clinician Feedback, Standards).
  • Design Input: Technical requirements translated from user needs.
  • Status Indicators: Visual icons (Edit, View, Delete) to manage individual entries.
  • Verification Testing Link: Tracks the status of tests validating each requirement.
  • Grouping: Group requirements by system component or regulatory standard (e.g., FDA, ISO 13485).
  • Listing Page: Display a full matrix view showing the relationship between requirements, design, and verification.
  • AI Generation Reference: Use AI to automatically map requirements to potential test cases and identify gaps.

Adding a Trace Entry​

Use the detailed form to establish links between different stages of the design control process.

Trace Matrix Entry Form

Form Fields​

  • Subsystem: usage area or component (e.g., Alarm System).
  • User Need: A specific need statement (e.g., "User requires clear notification...").
  • Design Input & Output:
    • Design Input: The measurable requirement.
    • Design Output: The specification or artifact that meets the input.
  • Verification:
    • Verification Design Output: The output being verified.
    • Design Verification Protocol: The test protocol used.
    • Verification Report: The results of the verification.