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Introduction – Compliance Matrix

This Compliance Matrix has been created to assist companies during their validation phase by providing traceability from regulatory requirements to test results. The document includes automated test cases, and we aim to continuously expand coverage in future updates to further support validation processes.

Overview of the pages in this file:

ISO 13485:

This page provides the compliance matrix for ISO 13485 requirements, linking:
• Regulatory requirement → Functional requirement → Functional specification → Test cases that validate compliance.
• Only sections 4.2.4 and 4.2.5 of ISO 13485 are applicable to TraceX, as they relate to document and record control.

21 CFR Part 820:

This page focuses on the Quality System Regulation (QSR) requirements applicable to an eQMS, specifically:
• §820.40 Document Control → Ensuring documents are reviewed, approved, updated, and properly distributed.
• §820.180 Records Control → Ensuring records remain identifiable, retrievable, and protected from loss or unauthorized modifications.

This compliance matrix also links each regulatory requirement to its functional implementation in TraceX, along with associated test cases.

21 CFR Part 11:

This page ensures compliance with FDA 21 CFR Part 11, which governs electronic records and signatures. It includes:
• Electronic signature validation → Authentication, user identity verification, and signing actions.
• Audit trails → Ensuring all system changes and approvals are logged with time-stamped records.
• Access controls → Role-based permissions to protect data integrity.
• This compliance matrix maps each 21 CFR Part 11 requirement to the functional implementation in TraceX and the corresponding test cases.

Test Results:

This page contains the automated test results, which are executed at each new version release to ensure continued compliance and system stability.


This matrix is intended to complement your internal validation package by providing traceability and pre-validated test cases to help you streamline your validation efforts.

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