Coverage, orphans, and inspection verdict — always current.
The Live RTM is always up to date — coverage gaps, orphan tests and inspection-readiness are computed on the fly from the links between requirements, design, tests and results. No more spreadsheet upkeep, no more RTM-freshness debates before an audit.
The requirements traceability matrix links every requirement to its specification, its test case and its result, and shows where coverage is missing. In GxP Copilot it is live: change a requirement and the matrix reflects it immediately, including any gap the change just opened, rather than waiting for someone to update a spreadsheet.
The document that is always out of date
The RTM is the document an inspector uses to navigate everything else, and in most organisations it is a spreadsheet maintained by hand. It is accurate on the day it is produced and decays from then on.
The decay is invisible until it matters. A requirement is reworded, a test case is split, a deviation changes an expected result — and the matrix still describes the version that existed at sign-off. Nobody notices because nobody reads it until an audit.
The worst version of this is a matrix that reports full coverage because the gaps were never added to it. A matrix that cannot show you a gap is not a control; it is a reassurance.
Live rather than reconstructed
Every generated test case is anchored to the requirement it verifies at the moment it is created, so the matrix is a view of the real relationships rather than a document assembled afterwards from memory.
When a requirement changes, the matrix changes with it. When a test is executed, the result appears against the requirement it covers. There is no separate update step to forget.
Where live traceability matrix sits in the lifecycle
Traceability is stage 4 of six. Select any stage to see what happens in it.
A traceability matrix built from the records themselves, so coverage gaps and orphan tests show as soon as something changes.
Anyone can check coverage at any time; no spreadsheet to keep up to date.
Gaps shown, not hidden
The matrix surfaces requirements with no test covering them, tests that verify nothing traceable, and requirements whose coverage exists but has not passed. These are the three things an inspector looks for, and they are visible to you before they are visible to anyone else.
An all-not-applicable result does not roll up as a pass. Verifying nothing is not the same as verifying successfully, and a matrix that treats them identically will eventually embarrass somebody.
A release gate with teeth
Coverage feeds a readiness verdict that refuses to let a summary report be released while anything material is open — unexecuted or failed cases, unpassed critical requirements, open deviations or changes, instruments out of calibration, or an outstanding requalification trigger. The blockers are listed by name rather than reported as a score.
This is the difference between a dashboard that tells you how ready you are and a control that stops you declaring readiness you do not have.
What you get
What Live Traceability Matrix delivers
Live Traceability Matrix is part of the GxP Copilot platform — an AI-native, CSA-first validation system built for regulated Life Sciences. See how it fits with AI Classification Engine, Risk-Based Validation Scoping, AI Risk Assessment.
- Always-current requirement → design → test → result
- Coverage-gap and orphan-test detection
- Live inspection-readiness verdict
- One-click export to PDF and CSV
Common questions
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What is a requirements traceability matrix?
It links every user requirement to the specification that addresses it, the test case that verifies it, and the result of executing that test. It is the document that lets an inspector confirm that everything specified was tested and everything tested traces to something specified, and it is where coverage gaps become visible.
Why do traceability matrices go out of date?
Because they are usually maintained by hand, separately from the work they describe. A reworded requirement, a split test case or a deviation that changes an expected result all leave the matrix describing a version that no longer exists — and nobody notices, because the matrix is only read during an audit.
Does full coverage mean the system is ready for release?
Not on its own. Coverage feeds a readiness verdict that also accounts for open deviations and changes, failed or unexecuted cases, unpassed critical requirements, instruments out of calibration and outstanding requalification triggers. A requirement covered only by not-applicable results is not treated as passed.
Related capabilities
All capabilitiesA guided intake — accelerated by AI, decided by your team — produces GxP impact, GAMP category and composite risk, along with the exact reasoning behind each result. Instead of week-long assessments, you get a classification you can defend to an inspector on the same day. The AI accelerates the input; the classification itself is transparent and controlled.
Learn more about AI Classification EngineRisk-Based Validation ScopingThe Strategy Engine picks the applicable deliverable set for each GAMP category and scales test rigor to per-requirement risk under CSA — choosing between scripted testing, unscripted verification, and leveraged supplier evidence. The output is a validation plan sized to reality, easy to defend, and quick to execute.
Learn more about Risk-Based Validation ScopingAI Risk AssessmentEvery requirement is scored against an ICH Q9 lens for severity, probability and detectability. That score drives the test strategy, the traceability coverage and the inspection-readiness view — so risk stops being a compliance formality and starts sizing your actual work.
Learn more about AI Risk AssessmentDocument Control & VersioningEvery document version is fingerprinted and tagged with its provenance and any AI assistance used. Data-driven sections stay canonical across every deliverable — so what you sign is what you keep, and what you keep is what you show an auditor.
Learn more about Document Control & VersioningAI Validation Document DraftingThe Documentation Engine drafts your validation deliverables in the style of the templates your organisation already uses — with confidence checks, review gates, and a fully functional fallback when the AI is unavailable. Your team stays in control; the platform removes the drudge work.
Learn more about AI Validation Document DraftingAI Test Case GenerationInstallation, Operational and Performance Qualification protocols are drafted from your requirements and design, right-sized by the risk engine, and structured for straightforward execution. Effort follows risk — high risk is scripted with an independent witness, medium is scripted or hybrid, and low risk can be unscripted with supplier evidence.
Learn more about AI Test Case GenerationSee live traceability matrix on your own requirements.
One real requirements document. We show you the draft package built from it, and you keep it either way.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan for your system