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Architecture, Standards & Jurisdictions

The deeper technical reference for the engine summarized on the homepage — where it sits in an industrial reference architecture, exactly which standard applies to which claim, and jurisdiction-by-jurisdiction coverage. This page carries the depth so the homepage doesn't have to.

Mapped to RAMI 4.0, not bolted onto it

RAMI 4.0 — Germany's Reference Architecture Model for Industrie 4.0 — defines how industrial systems relate across hierarchy, lifecycle, and function. Kaelox is positioned deliberately within it:

FUNCTIONAL LAYER

P→D Bridge & HITL Gate

Enforcement logic operates here — evaluating and gating AI-influenced decisions before they propagate downward.

INFORMATION LAYER

ALCOA+ Chain & AEMS

The governance record lives here — structured, queryable, and the source of truth for everything above it.

ASSET / FIELD LEVEL

Configure Mothership

Deployment is scoped to the Station and Work Centre hierarchy levels RAMI 4.0 defines — facility by facility.

Which standard applies to which claim

Kaelox is built toward several distinct standards, each covering a different question. Stated separately, on purpose, so a claim about cybersecurity is never mistaken for a claim about functional safety.

StandardQuestion it answersStatus
IEC 61508 SIL3Functional safety of the software safety core (a COTS component reported as TÜV Süd-certified)Vendor-disclosed — licensing and scope being independently verified before this claim is repeated externally
IEC 62443 SL2 (SDLA + CSA)Cybersecurity of the platform itself — the deep-tech/AI threat model, SBOM, secure development lifecycleTargeted, assessment not started
ISO 26262 / ISO-IEC TR 5469Automotive functional safety and AI-specific guidance, relevant to robotics/edge deploymentsReference framework for Phase I robotics work
21 CFR Part 11 / ALCOA+Electronic records and audit-trail integrityEnforced today, built into the chain
FDA QMSR / GAMP 5Quality management system and validation evidence structureStructured output generated today
EU AI Act, Article 15Adversarial robustness and explainability for high-risk AI systemsApplicability date under active reconciliation — see Standards Registry note below

Open item: the EU AI Act Article 15 applicability date has conflicting public guidance (Digital Omnibus carve-out status). Logged as unresolved in our internal Standards Registry; not blocking any shipped requirement, and stated here rather than rounded to whichever date is more convenient.

One chain. Every jurisdiction it touches, governed correctly.

The Multi-Jurisdiction Compliance Engine reads a single configuration flag at CONFIGURE and changes what's enforced — applicable standards, egress policy, and audit format — without changing the underlying chain.

United States
FDA QMSR · ITAR · FCC
European Union
MDR/IVDR · EU AI Act · GDPR
United Kingdom
MHRA · UK GDPR
India
CDSCO · Revised Schedule M · DPDP Act
Saudi Arabia
PDPL · SASO
Australia
TGA · AUKUS
Japan
PMDA · METI
South Korea
MFDS
China
NMPA · GB Standards