Welcome to TraceUnified

TraceUnified is one connected system for the regulated engineering lifecycle. Requirements, architecture, tests, risk, and the software bill of materials live as native records in a single database — joined by governed traceability and a tamper-evident audit trail that is captured as you work, not reconstructed before a submission.

The problem it solves

In most programs, the lifecycle is spread across separate tools: a requirements tool, a modeling tool, a test manager, a risk register, spreadsheets for the rest. The connections between them — the traceability an auditor asks for — are maintained by hand and drift out of date the moment work moves. Proving coverage becomes a project of its own.

TraceUnified removes the seams. Because every artifact lives in the same system, a requirement, the architecture that realizes it, the test that verifies it, and the risk that constrains it are linked directly. Change one and the system flags what downstream is now suspect. Coverage is always live, and the evidence for an audit is a by-product of normal work.

Who it’s built for

TraceUnified is built for teams developing under regulation and recognized standards — medical devices and combination products under FDA 21 CFR Part 11 and GxP, and adjacent safety-critical domains such as aerospace, automotive, and industrial systems. If your process depends on controlled records, electronic signatures, and demonstrable traceability, the platform is designed around those requirements rather than bolting them on.

How to use this guide

If you’re new, work through this section in order: sign in, learn the workspace, understand the core concepts, then create your first project. If you’re already up and running, jump to the module that matches what you’re doing — each section stands on its own.