Trusted Data Framework

Trusted data foundations for AI in regulated industries.

We help enterprises in energy, industrial, life sciences, and financial services make their data audit-ready, traceable, and safe for AI — built on the standards their regulators already expect.

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Business impact delivered
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Enterprise data leadership
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Regulated industries served
SENSORS ERP LIMS RECORDS 3RD-PARTY TDF QUALITY GATE + LINEAGE TRUSTED DATA AGENTIC AI
OSDUIEC 62443GAMP 5ALCOA+21 CFR Part 11BCBS 239ISO/IEC 42001NIST AI RMFEU AI ActHIPAAISO 8000DORA OSDUIEC 62443GAMP 5ALCOA+21 CFR Part 11BCBS 239ISO/IEC 42001NIST AI RMFEU AI ActHIPAAISO 8000DORA
Why this matters now

In regulated industries, AI fails on data — and the regulators are watching.

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of enterprise AI pilots never reach production. The leading cause is ungoverned, untraceable data — not the model itself.

MIT research, 2026
Aug 2026

EU AI Act high-risk obligations take effect — mandating data governance, lineage, logging, and human oversight for regulated AI systems.

Regulation (EU) 2024/1689
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fined to a single global bank for failing to manage risk data under BCBS 239 — the same gap that sits inside most AI programs today.

Regulatory record, public
Industries we serve

Deep expertise in six regulated sectors.

Each industry has its own data standards, regulators, and failure modes. We bring the specific framework your sector is measured against — not generic governance theory.

Oil & Gas

Subsurface, drilling, production, and asset data scattered across proprietary systems and decades of legacy formats — now expected to feed AI for exploration, predictive maintenance, and carbon reporting.

The wall: Your AI models can't reason across siloed subsurface data, and IT/OT convergence has opened a governance and security gap the OSDU 1.0 standard now expects you to close.

Standards & frameworks we apply

OSDU 1.0Open Subsurface Data Universe — the open data platform standard from The Open Group, now at v1.0, that breaks subsurface data silos and enables governed, API-driven access.
PPDMProfessional Petroleum Data Management — industry data model for upstream master data and reference standards.
ISO 15926Lifecycle data integration for process plants and oil & gas facilities — interoperability across engineering data.
IEC 62443OT cybersecurity for the IT/OT boundary — protecting operational data integrity from field sensor to data lake.
ISO 8000Data quality — the master standard for measuring and certifying enterprise data quality.

Industrial Automation

PLCs, drives, robotics, SCADA, and MES generating continuous operational data — where IT and OT systems historically ran in silos with different priorities, tools, and security models.

The wall: Bridging IT and OT for AI-driven predictive maintenance and quality analytics without exposing safety-critical control systems — exactly what IEC 62443 zoning was built to govern.

Standards & frameworks we apply

IEC 62443The leading OT security standard — recognised by IEC as horizontal across all industries using industrial control systems. Defines zones, conduits, and security levels.
ISA-95Enterprise-control integration — the model for connecting plant-floor operations to business systems and data.
ISA-99Industrial control systems security — foundational practices underpinning the 62443 series.
ISO 27001Information security management — securing the IT side of IT/OT convergence and the data flowing between them.
ISO 8000Data quality — ensuring sensor and telemetry data is trustworthy before it reaches AI.

Home Automation & IoT

Connected devices generating vast streams of consumer behavioural and telemetry data — where privacy, consent, and device-level security are the foundation of customer trust and AI personalisation.

The wall: Training AI on consumer IoT data while honouring privacy and consent, and securing a fleet of distributed devices to a certifiable standard buyers and regulators now demand.

Standards & frameworks we apply

IEC 62443 ICSAIoT Component Security Assurance — the ISA certification scheme for securing connected IoT components and devices.
MatterSmart-home interoperability standard — governing secure, consistent data exchange across connected home devices.
ISO/IEC 27701Privacy information management — extending security management to personal and consumer data handling.
GDPR / CCPAConsumer data privacy — consent, data minimisation, and the right to deletion built into the data pipeline.
NIST IoTNIST IoT cybersecurity guidance — baseline device security and data protection for connected products.

Pharmaceuticals

Manufacturing, quality, and clinical data under the strictest data-integrity regime in any industry — where a single audit-trail gap can trigger a warning letter, import alert, or plant shutdown.

The wall: Adopting AI in GxP environments while maintaining ALCOA+ data integrity and 21 CFR Part 11 compliance — and preparing for the 2026 FDA-EMA joint AI principles.

Standards & frameworks we apply

GAMP 5Computerised system validation — the risk-based industry standard for validating GxP systems, including the 2nd edition AI/ML guidance.
ALCOA+Data integrity principles — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available.
21 CFR Part 11Electronic records & signatures — FDA requirements for audit trails, access controls, and validated systems.
EU Annex 11European computerised systems — the EU equivalent of Part 11 for GxP environments.
ICH E6(R3)Clinical trial data governance — finalised January 2025, establishing global data governance requirements for trials.

Healthcare

Patient records, diagnostic imaging, and clinical decision data feeding AI systems — where data provenance and validation directly determine FDA clearance and hospital procurement outcomes.

The wall: Your health-AI product works, but the data lineage and validation documentation needed for FDA submission and hospital enterprise sales is not yet in place.

Standards & frameworks we apply

FDA AI/MLFDA AI/ML Action Plan — data quality, provenance, and lifecycle requirements for AI-based medical devices and clinical decision support.
HIPAAProtected health information — privacy and security rules governing patient data used in AI.
21 CFR Part 11Electronic records — audit trails and validation for regulated health data systems.
Real-World DataRWD validation — vetting EHR, wearable, and digital-health data for integrity before regulatory use.
ISO/IEC 42001AI management system — increasingly a procurement requirement for health-system vendors.

Financial Services

Risk, transaction, and customer data under intense regulatory scrutiny — where AI in credit scoring, fraud detection, and trading is now classified as high-risk and subject to mandatory governance.

The wall: Demonstrating data lineage and quality for BCBS 239 and the EU AI Act's high-risk obligations — when frameworks exist on paper but the controls aren't actually running in production.

Standards & frameworks we apply

BCBS 239Risk data aggregation — the Basel Committee principles for risk data and reporting, now an ECB on-site inspection priority through 2027.
EU AI ActHigh-risk AI obligations — credit scoring, fraud detection, and algo trading are classified high-risk, with data governance mandated from August 2026.
SEC AISEC AI guidance — emerging US requirements for AI use, data governance, and disclosure in financial services.
DORADigital Operational Resilience Act — EU regime for operational resilience of financial firms using AI in critical functions.
MAS FEATFairness, Ethics, Accountability, Transparency — Singapore's principles for AI in finance, widely referenced globally.
What we do

Three ways to work with us — start small, scale as trust builds.

Fixed fees. Clear deliverables. Mapped to your industry's specific standards.

01
TDF Audit
Start here
A 4-week diagnostic benchmarking your data against your sector's standards before it touches AI.
  • Stakeholder interviews across data, IT/OT, and compliance
  • Architecture & lineage review against your industry framework
  • TDF Maturity Score (0–100) across 5 pillars
  • Prioritised 90-day roadmap mapped to your regulators
$15,000
fixed fee · 4 weeks
02
TDF Build
We design and implement the framework — governance, stewardship, and the quality gates your AI needs.
  • Full governance model + stewardship operating model
  • Quality gate implementation on priority data domains
  • Change management and staff training
  • Regulatory alignment to your industry standards
Scoped on engagement
project · 3–6 months
03
TDF Operate
Ongoing fractional governance leadership for teams that need a steady hand without a full-time hire.
  • Monthly governance reviews
  • Continuous data quality monitoring
  • AI deployment oversight
  • Regulatory readiness updates
$5K–$8K
per month · 6 mo min
The methodology

Five pillars. One readiness score.

A common framework that maps to every industry standard — so a single assessment speaks to OSDU, GAMP 5, BCBS 239, or IEC 62443 alike.

01 / LINEAGE

Data Lineage & Provenance

Every data asset traceable from source to AI consumption. Answer "where did this come from?" in seconds — the heart of every audit.

02 / QUALITY

Quality Gates

Automated checks that catch bad data before it reaches a model — aligned to ISO 8000 and ALCOA+.

03 / OWNERSHIP

Governance Ownership

Clear stewardship roles and escalation paths. People know who owns what data and what to do when something breaks.

04 / SCORE

AI Readiness Score

A 40-question assessment producing one number leadership and regulators can act on.

05 / AUDIT

Compliance Trail

Full documentation for your industry — BCBS 239, 21 CFR Part 11, EU AI Act, IEC 62443.

Responsible & governed AI

The frameworks every serious AI program now answers to.

Whatever your industry, your AI governance is measured against this convergent set of global standards. We build to all of them with a single set of controls.

ISO/IEC 42001

The first international AI Management System standard. Increasingly a procurement requirement in financial services, healthcare, and public sector — the certifiable shape of AI governance.

NIST AI RMF

The US risk-management framework structured around Govern, Map, Measure, Manage. Referenced by the SEC, FDA, CFPB, and DoD as the benchmark for vendor AI maturity.

EU AI Act

The first binding AI law. High-risk obligations — data governance, logging, human oversight — apply from August 2026, with financial penalties for non-compliance.

Responsible AI

Fairness, transparency, accountability, and human oversight built into the data foundation — because trustworthy AI starts with trustworthy data, not a policy deck.

Why us

Built by practitioners who've done this at scale — not consultants who've only written about it.

Our methodology comes from 25 years of hands-on delivery inside three of the world's largest energy, industrial, and technology enterprises.

Global energy major
$70M+

in data value preserved by modernising 9 global data hubs onto a governed cloud architecture, enabling AI analytics across 20+ markets.

Global industrial automation leader
15–20%

energy savings delivered through a cloud-native industrial data platform with real-time ingestion and governed reporting.

Global technology & healthcare platforms
15+

enterprise platforms delivered across public sector, transportation, and regulated healthcare on three continents.

How it works

From first call to readiness score in four weeks.

Week 0

20-minute call

We listen. No pitch — just understanding your current data, AI, and regulatory setup.

Week 1

Stakeholder interviews

5–8 conversations across data, IT/OT, compliance, and business teams.

Week 2

Architecture & lineage review

We map your data flows and controls against your industry's specific framework.

Week 3

TDF Maturity Assessment

Your data is scored across all five pillars — a concrete 0–100 readiness number.

Week 4

Report & roadmap

You receive the full report and a prioritised 90-day action plan, presented to your team.

Get in touch

Tell us where your AI is hitting a data wall.

One reply, usually within a business day. No automated sequences.

Your AI roadmap is only as strong as the data underneath it.

Start with a 4-week TDF Audit, benchmarked to your industry's standards. Fixed fee. Clear answers in a month.