The platform
One system for the entire regulated lifecycle.
Requirements, architecture, tests, risk, and SBOM as native records in one database — connected by governed traceability, audit-ready by default. Here's a look at each piece.
The workspace
Every module in one workspace.
Requirements, architecture, tests, risk, and SBOM — with planning, analysis, and compliance — all in one left-hand navigation, each module opening to its own live dashboard of coverage, status, and readiness.
Requirements
Author requirements as governed records.
Every requirement is a versioned, controlled item with its own identity, lifecycle, and state — scored for quality and checked for compliance as you write, not after the fact.
Architecture
Model your system in native SysML.
Block, internal-block, and parametric diagrams live in the same database as your requirements — real model-based systems engineering, not a drawing pinned to a ticket.
Tests
Plan, run, and track verification.
Test plans, runs, and milestones with pass/fail status and re-run history. Verification evidence is captured as you go — and stays linked to the requirements it proves.
Risk
Manage hazards and risk in context.
Risk registers with severity, priority, and mitigation status — each risk linked to the requirements and components it touches, so nothing is assessed in isolation.
SBOM
Your SBOM, on the thread.
Import CycloneDX or SPDX and every component becomes a first-class item — linked to the risks it threatens and the tests that cover it, with CVE/CVSS tracking and suspect propagation when a vulnerability lands.
Traceability
One connected thread.
Native, deterministic links across every artifact — human-made, not inferred. Change one item and downstream links flag suspect for re-verification, with live coverage you can audit.
Review Center
Run formal reviews across every module.
Review sessions bring the right artifacts and reviewers together in one place — track status, velocity, and reviewer workload, with every comment and decision captured as part of the record.
Approvals
Sign off with enforced electronic signatures.
Multi-step approval chains define exactly who must sign and in what order — each gate enforced with 21 CFR Part 11 electronic signatures and a complete signature history, so an item only advances once the people accountable have signed.
Releases
Bundle and approve releases with confidence.
Plan releases as governed bundles of modules, track each status from draft through GA, and approve the whole package against the evidence behind it — so what ships is exactly what was reviewed and signed.
Dashboards & reporting
See the whole program at a glance.
Coverage, quality score, and compliance readiness across every module, in one view you can export — so a status review or an audit starts from live data, not a spreadsheet.
Built for compliance
Engineered to enable 21 CFR Part 11, ISO, and safety-critical development.
Controlled states, electronic signatures, and a tamper-evident audit trail run through every module — so the evidence an auditor asks for is a by-product of the work, not a scramble before a submission.