Sovereign AI for regulated markets

AI you can defend.

AiVACO builds sovereign AI and data systems for pharmaceutical and life sciences, education, government and other highly regulated markets. Every AI output is grounded, validated, risk tiered and recorded before anyone relies on it, inside an environment you control.

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Designed in alignment withEU AI ActEU GMP Annex 11 and draft Annex 22ICH Q9(R1)GAMP 521 CFR Part 11UK GDPR
The problem

AI is already inside your organisation. The evidence is not.

Generative assistants, AI switched on inside enterprise software and models used by suppliers have arrived faster than the governance around them. Regulators have noticed. The question is no longer whether AI is useful. It is whether you can show an inspector, an auditor or a minister what your AI did, what it relied on and who was accountable.

Shadow AI

Staff use general purpose assistants, often on personal accounts, with information that should never leave your organisation.

Embedded AI

AI features arrive by default inside the quality, document, learning and enterprise systems you already own, frequently without an intended use or an owner.

Unexplainable outputs

Probabilistic models can give different answers to the same question, and few leave a record you could defend.

Our approach

Separate the AI that generates from the control that verifies.

AiVACO places a deterministic assurance layer between any AI model and the regulated process it serves. The layer itself contains no AI. It grounds every output in your approved sources, applies encoded rules, assigns a risk tier, records the result before release and keeps a qualified person accountable for every decision that matters. Your data, your models and your evidence stay inside your environment.

How AAP works →
Any AI model → AiVACO Assurance Layer → your processcontains no AI
01

Ground

approved, current sources

02

Validate

encoded rules, pass or fail

03

Risk tier

A1 to D4

04

Record

before release

05

Release

or refuse, or escalate

A1
AUDITrecord committed before release
What we do

One platform, one practice, one purpose: AI with evidence you can defend.

Proof by design

Design facts about the platform, not performance claims.

5
deterministic stages applied to every AI output
0
AI components inside the control layer
16
risk tiers, from A1 to D4
100%
of outputs recorded before release, including refusals
90
days to inspectable evidence in shadow mode
Markets we serve

Built to the hardest standard, applied wherever the consequence is real.

Interactive demonstrator

Watch assurance happen.

Explore our interactive demonstrator. Follow eight scored scenarios, from a simple factual lookup released at tier A1 to a blocked data integrity attempt stopped at D4, and see how every decision is recorded and escalated.

Illustrative concept using fictional data. Not a validated system.

Demo capture (replace with screenshot of the demonstrator)
EXAMPLE
Brand film

Ninety seconds on why the control must contain no AI.

CC Captions01:30
WHITEPAPER · OCTOBER 2026

Building an AI Strategy You Can Defend

Free whitepaper

Building an AI Strategy You Can Defend

A practical guide for Quality, Validation, IT and governance leaders who are being asked to approve, pilot or scale AI, and need a defensible basis for doing so.

  • The regulatory landscape across the EU AI Act, EU GMP, FDA and EMA, and where they converge
  • The critical boundary set by draft Annex 22, and where generative AI legitimately fits
  • Pharmaceutical manufacturing as the reference case for every regulated sector
  • A consequence based model for scoping AI pilots
  • A six phase framework for building an AI strategy
  • A technical assurance checklist Quality and IT can use today

We will email you the PDF and occasional insights on AI assurance. You can unsubscribe at any time. Privacy policy

Also available: The AI Assurance Checklist, a one page summary of the eight assurance domains. Download the checklist

Start with the question an inspector will ask.

Where are you using AI, and could you defend it tomorrow? Book a 30 minute briefing and we will help you find out.