Normantic

Requirement traceability

The chain from regulation to test case — and proof that it holds.

Normantic builds the linked chain auditors ask for, then scores every link with a model: is this requirement actually covered downstream, and does the child requirement faithfully carry its parent's obligation? Weak links surface while you can still fix them.

REGMDR 14.2 URSLogging FRSCapture SRSValidate TC-1 TC-2 92 88 54
Every link is scored twice: how much of the parent it covers, and how faithfully it restates it. A 54 is where the audit finding would have been.

How it works

  1. Author or import the chain

    Start from a regulation clause and work down — user requirement, functional, software, test case — or paste in what you already have. Cards are plain text; the structure is the point.

  2. Link what belongs together

    Draw a link and the model reads both sides. It suggests downstream candidates you missed and flags links that do not survive reading: an obligation split in half, a child that invents a mechanism its parent never asked for.

  3. Score, fix, approve

    Coverage and quality roll up per level, so a project reads as two rows of numbers before it reads as a graph. Approving an edit writes a checkpoint: a full, timestamped snapshot with the cards that changed.

What you get when someone asks for evidence

Scored links, not asserted ones

A traceability matrix with a tick in every cell proves nothing. Each link here carries a coverage score, a faithfulness score and the model's justification in plain language.

A change log you can hand over

Every approval is a checkpoint: who changed what, when, and the whole project as it stood. Reverting is a first-class action, not a database restore.

Safe concurrent editing

An in-progress edit locks exactly the cards it touches, so two people can work one graph without silently overwriting each other. Abandoned edits time out and can be recovered.

Your text stays yours

Requirements live in your own database in your own cloud account, and the model sees only the two cards it is scoring — never the whole project, never for training.

Who it's for

Teams that have to show a regulator, a notified body or an internal auditor why a test proves a requirement — medical device software under IEC 62304 and EU MDR, validated systems under GAMP 5, and anyone maintaining a URS → FRS → SRS → test chain that has grown past the point where a spreadsheet can be trusted.

EU MDR 2017/745IEC 62304GAMP 5ISO 13485IEEE 830

Normantic is in closed beta.

Accounts are created by hand, one team at a time, so we can sit with you while the first chain goes in. Tell us what you are tracing and we will get back to you.

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