Documentation and Traceability

Documentation and traceability mean you can show, for any security requirement, where it was designed in, how it was implemented, and which test proved it works. FDA reviewers expect that chain of evidence in a premarket submission, and your own engineers will need it when they revisit the code years later.

4.7.1 Security Requirements Traceability

Connect everything:

flowchart TD
    A[Security Requirement] --> B[Design Decision]
    B --> C[Implementation]
    C --> D[Test Case]
    D --> E[Test Result]
    E --> F[Verification Evidence]

4.7.2 Development Security Documentation

Document these development artifacts:

Security Design Decisions

• Why you chose specific algorithms
• Trade-off analyses
• Alternative considerations
• Risk acceptances

Implementation Details

• Security control descriptions
• Configuration parameters
• Integration points
• Known limitations

Test Evidence

• Test plans and procedures
• Test execution records
• Defect tracking
• Resolution verification

For the matrix structures FDA reviewers expect to see, see How to create FDA-compliant cybersecurity traceability matrices.