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Traceability matrix

The Requirements Traceability Matrix (RTM) is built live from the records: requirements, their tiers, the tests that cover them, executions per environment and deviations. There is nothing to regenerate.

Using the RTM

Filter by tier, status and tag. Each gap links to the record that needs fixing. Export to CSV, print, or save as PDF.

Gap codes

The Validation Summary Report cannot be signed while any gap is open.

Gap code Meaning
document-not-approved A lifecycle document is not approved.
risk-not-assessed A requirement has no risk assessment.
uncovered-requirement A requirement has no test.
orphan-requirement An FS or DS requirement does not trace to a URS requirement.
orphan-test A test is not linked to any requirement.
high-risk-no-evidence A Tier 1 requirement has no passing scripted execution with objective evidence.
high-risk-evidence-unscripted-only A Tier 1 requirement is covered only by unscripted testing.
tier-method-mismatch A Tier 2 requirement is covered only by unscripted testing.
executor-not-independent A Tier 1 manual test was run by its own author.
not-executed A test has not been executed.
not-passed-in-environment A test has not passed in an environment it must pass in, and no closed deviation covers it.
test-changed-since-execution A test was changed after it was executed.
failed-without-closed-deviation A failed execution has no closed deviation.
open-deviation A deviation is still open.

Where pytest-gxp already reports the same condition, the code uses pytest-gxp's name.

Fixing gaps

Gap Usual fix
document-not-approved Submit, review and approve the document.
risk-not-assessed Answer Q1 (and Q2) on the requirement. See Requirement tiers.
uncovered-requirement, orphan-test Link the test case to the requirement.
orphan-requirement Trace the FS/DS requirement to a URS requirement.
high-risk-*, tier-method-mismatch Add a scripted test (with evidence for Tier 1).
executor-not-independent Have someone other than the author execute it.
not-executed, not-passed-in-environment Execute the test (in that environment).
test-changed-since-execution Execute the changed test again.
failed-without-closed-deviation, open-deviation Raise and close a deviation. See Deviations.