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Every requirement, tracedto the step that proved it.

The requirements traceability matrix builds itself while the run happens. Requirement to script to step to evidence to defect to report. No spreadsheet.

Book a demoWhere it sits in the chain
One chain, end to end
  1. This pageApproved requirement
  2. Test scripts
  3. Autonomous execution
  4. You take over
  5. Defects logged
  6. This pageSigned OQ / PQ report
Matrix

The matrix is a by-product, not a document you write.

The requirements traceability matrix builds itself as the run executes.

  • Forward and backward traceTrace from requirement to evidence, or back again.
  • Coverage counted per requirementCoverage is counted, not estimated.
  • Part of the reportThe matrix is section 4.0 of the OQ / PQ report.
OQ-2214 · RTM5 of 14 requirements shown
RequirementScriptStepsResultEvidence
URS-014.1TS-014-0118Pass9f3c…a71e
URS-014.2TS-014-0214Pass4b0e…c2d9
URS-014.3TS-014-0421Passd71a…08f4
URS-014.4TS-014-0517Passe2c8…5b13
URS-014.5TS-014-0626Fail · DEF-0311c5f…3e6a
0 of 14 traced
Trace path

Pick a requirement. See the whole path.

Every requirement has a path from itself to the evidence and the report line that proved it.

  • Gaps flagged earlyGaps are flagged before execution starts.
  • Untested blocks the reportAn untested requirement blocks the report.
  • Every link opens the recordEach node in the path opens its record.
Trace pathURS-014.5
URS-014TS-014-06Step 6DEF-031OQ-2214 § 3.0
Change

When a requirement changes, you see what it touches.

A change to a requirement shows its impact before you re-run anything.

  • Impact list per scriptEvery affected script is listed.
  • Re-run only what changedOnly affected scripts are re-run.
  • Revisions retainedPrevious matrix revisions are retained.
Change impactURS-014.3
URS-014.3 changed2 scripts · 11 steps affected
Exports

RTM as PDF, Excel, or CSV. Included in the OQ / PQ report, section 4.0.

PDFExcelCSV
Before and after tracing

Where the matrix starts, and where it lands.

BeforeTest script generationEvery script carries the requirement ID the matrix is built from.AfterE-signatures and complianceThe report the matrix belongs to is signed under 21 CFR Part 11.Use caseChange management and re-validationA change request maps to the requirements, scripts, and steps it touches.

Questions about traceability.

If your question is not here, ask us. We reply within one working day.

Can we import an existing RTM?

This is under review.

Does it trace to URS, FRS, and configuration specification?

Yes, any approved document you upload.

What counts as covered?

A requirement with at least one executed step with evidence, and no open defect that blocks acceptance.

Can an auditor filter by risk level?

Yes.

Now onboarding validation pilot partners

See a full run on one of your systems.

Bring one approved requirement. We show you the chain end to end, on a system you already use, in under an hour.

Book a demo
Reply timeOne working day
FormatLive run, 45 minutes