Keeps a live trace graph and flags everything a change touches.
Requirements, evidence, tests and signatures become linked records. Change one requirement and the Trace Agent shows every test, document and signature it affects.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
An AI trace agent maintains the links between requirements, evidence, tests and approvals as a live graph instead of a static matrix. When anything changes, it shows every item the change affects.
Qualitum’s Trace Agent builds the graph from the work of the other agents. It flags orphan tests, untested requirements and signatures that need re-approval, and exports a requirement traceability matrix in your format when you need one.
Every requirement, evidence link, test and signature becomes a linked record.
A new spec revision, test result or document version updates the graph.
You see every affected item, and who needs to re-approve.
Requirements, evidence, tests and signatures as linked records.
Every item a change touches, shown in seconds.
Tests without requirements and requirements without tests.
A traceability matrix in your format, any day.
Every state of the trace, replayable for the auditor.
Shows which approvals a change invalidates.
Every output links back to its sources and waits for a person to sign.
| Manual / consultants | Generic AI (ChatGPT, Copilot) | Qualitum Trace Agent | |
|---|---|---|---|
| Sources cited | Sometimes, in comments | Rarely, and often wrong | Every answer, with page and clause |
| 100% coverage | Sampled when time runs out | Skips what it does not notice | Every requirement, every cycle |
| Works in your templates | Yes, by hand | Generic format | Your templates and numbering |
| Runs in your perimeter | Yes | Usually public cloud | Single-tenant, air-gap capable |
| Audit trail | Partial, kept by hand | None | Every action attributable |
| Human sign-off | Yes | Not enforced | Always. Agents prepare, people sign. |
Every agent reads the same Consensus OS knowledge graph, so work moves between them without re-reading.
Splits any spec into testable, risk-tagged requirements.
Meet the agentLinks every requirement to the page that proves it.
Meet the agentWrites IQ/OQ/PQ, FAT/SAT and test specs in your templates.
Meet the agentShows the impact of every change before you approve it.
Join the design partner listYes. The RTM is exported from the graph in your format whenever you need it, and it is always current.
A new requirement revision, a new evidence version, a test result or a signature. The graph updates and flags what changed.
No. It shows which approvals a change affects. A person re-approves.
Yes. Your current matrix is read and every link checked before it enters the graph.
No. It prepares and checks. A qualified person on your side reviews, approves and signs every regulated output. Your AI CQO prepares. Your qualified person signs.
Nowhere outside your perimeter. Qualitum runs single-tenant inside your cloud or on-prem, with EU, US or UAE residency and air-gap capability. No training on your data, no retention.
The one you choose. Consensus OS sits on top of any frontier or open model, and the Verifier Agent checks results across several models.
Send two documents for a free gap report in 48 hours. A pilot runs 8 to 12 weeks on one real project, with one qualified reviewer from your team.