Every requirement, risk, and test —
one living map.
Provenous turns your regulated engineering process into a living system of record that stays accurate automatically. Ask what your Design History File looked like on the day of your last submission, and get a real answer — not a spreadsheet reconstruction.
Your traceability matrix is only ever as true as the last person who remembered to update it.
Engineering teams in regulated industries (medical devices, automotive, aerospace) spend 30–40% of their time manually proving traceability between requirements, design, code, tests, and risk controls. When a requirement changes, they manually trace downstream impacts — often missing critical links, leading to failed audits, delayed product launches, and millions in revenue loss.
Ask a regulated engineering team what their Design History File looked like on the day of their last submission. Most can't actually answer that — it's already been overwritten, and nobody kept the receipts.
What's actually built in, not roadmapped.
Eight mechanisms that turn "we have a traceability tool" into "we can prove it, on any date, to anyone."
No AI ever decides who's who
Every requirement, hazard, and test resolves by its real source-system ID, deterministically. AI drafts relationships and language — never identity.
Hash-chained, tamper-evident
Every change is an immutable, cryptographically chained event. An operator with database access still can't rewrite history without breaking the chain.
Ask what was true, on any date
Tag a moment — "510(k) Preliminary Submission" — and revisit it forever. Computed live from real history, never a frozen export.
See the blast radius before you ship
Change one requirement and every downstream hazard, test, and commit is walked automatically — flagged before anyone has to ask.
AI proposes, a human signs
Suggested links, risk drafts, and change judgments sit visibly pending until confirmed — with a 21 CFR Part 11 electronic signature on the terminal decision.
Draft-quality FMEA, not a blank page
Requirements with no risk analysis yet get candidate ISO 14971 failure modes drafted for your risk engineer to review — never auto-filed.
CAPA, non-conformance, complaints — connected
Quality records connect directly to your engineering data, aligned to 21 CFR 820 and ISO 13485 — not a separate system you reconcile by hand.
SRS, SDD, DHF — generated, not assembled
Technical files render on demand, straight from current data, as PDF, Word, or Excel, from any as-of date or tagged milestone.
One trace, start to finish.
Every link in that chain is a fact your existing tools already produce — Jira, Jama, GitHub, Jenkins, Confluence. Provenous Core's connectors normalize each one automatically, so the chain updates itself instead of waiting for someone to notice it's out of date.
Speaks the standards your auditor already speaks.
Live today: Life Sciences & MedTech design controls, risk management, and electronic records. The same Provenous Core is architected to extend to other regulated verticals — see all solutions — without re-platforming.
Not a nicer report. A different source of truth.
See your own traceability matrix, as of any date.
A working walkthrough on your own process — not a slide deck.
Request a walkthrough