Governed AI for GxP-Regulated Manufacturers

Your team is already using AI. Is it MHRA-ready?

MHRA inspections are increasingly flagging ungoverned AI tools as corrective action items. Annex 22 is finalising and the compliance gap is closing for EEA exporters. Streetbeat ACE is the governed AI platform built for MHRA-licensed manufacturers: audit trail included, supplier qualification dossier ready, compatible with EU GMP Annex 11 and Annex 22 principles. Proven in production at highly regulated enterprises. ISO 27001 and SOC 2 certified.

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In production at highly regulated enterprisesISO 27001 and SOC 2 certifiedNo model training on patient dataGxP-compatible audit trail

Shadow AI is already in your QA team. The inspector will find it before you do.

Your teams are already using AI to get through document backlogs and PV intake queues. None of it has an audit trail, none of it is versioned, and none of it will survive an MHRA inspector asking what your AI did on a given date. Under Annex 22, that question is coming. Your DPO blocked general-purpose tools for good reason: no architecture controls for UK GDPR Art. 9 health data. Your teams are still using AI anyway, just the uncontrolled kind. EU GMP Annex 22 reaches final text in 2026, and UK EEA exporters face dual MHRA and Annex 22 obligations. Manufacturers who wait will be validating AI under regulatory scrutiny, not before it.

How It Works

Active

GxP Document Review Agent

SOP and batch record review against approved methodology.

Active

PV Intake Processor

Structures adverse event intake data. Full audit trail.

Active

CAPA Tracking Agent

Monitors corrective action progress, flags overdue items.

Scheduled

Annex 22 Gap Monitor

Weekly gap briefing vs. EU GMP Annex 22 draft.

Active

Supplier Qualification Agent

Structures qualification dossiers for MHRA/EMA review.

In review

Deviation Report Agent

Drafts deviation reports from QA investigation data.

Your methodology, encoded in versioned agents.

Each engagement type (PV intake triage, document QC, regulatory writing, deviation triage) becomes a governed agent built on your team's own process logic. Every agent configuration is versioned and change-controlled. Your QP can point an inspector to the exact agent version active on any given date.

GxP corrective actions and validation activities - tracked, owned, auditable.

Priority	Name	Status	Owner	Deadline
High	IQ/OQ/PQ - ACE Agent Module v2	Active	R. Patel	2026-07-31
High	CAPA-2026-014 Deviation Investigation	Active	J. Moore	2026-07-15
Medium	Supplier Qualification - API-grade	In review	S. Nguyen	2026-08-10
Medium	Annex 22 Gap Remediation Plan	Active	R. Patel	2026-09-01
Low	Change Control - SOP Update v4.2	Pending	J. Moore	2026-10-01
High	PV System Validation - GAMP 5 Cat 4	Active	M. Silva	2026-07-20

Every agent action logged. Every run auditable.

Agents run automatically across your engagements. The run log is immutable and exportable: the same audit trail you would expect to show the MHRA for a client's process, applied to your own delivery. IQ/OQ/PQ-ready by architecture.

QA SOPs

Document Control SOP v4.1

Change Control Procedure v3.0

Deviation Management SOP v2.2

Regulatory Refs

EU GMP Annex 11 - Computer Systems

Annex 22 AI Draft Framework

MHRA Data Integrity Guidance

Supplier Qualification

Qualified Supplier List Q2-2026

Scope

Applies to all GxP-relevant documents across manufacturing, QA, and regulatory affairs.

AI Processing Rules

Agent configs versioned per SOP revision. Outputs require QA sign-off. Audit trail mandatory.

Annex 22 Alignment

Run logs satisfy Annex 22 requirements for AI audit trail and human oversight.

Your company's regulatory knowledge, structured and versioned.

Regulatory frameworks, internal guidance, engagement templates: all accessible to your agents, controlled by you. Knowledge that used to live in a senior QA specialist's head becomes consistent, searchable, and encoded into every output.

How you go live

30 minutes

Qualification call

We map your current AI exposure: shadow tools in use, document QC backlogs, PV intake volume, upcoming inspection timeline. We confirm whether Streetbeat ACE is the right fit. No slides, no pressure.

4–6 weeks

Scoped PoC

Fixed-scope proof of concept on one or two of your highest-priority workflows. You see governed AI operating on your actual processes within weeks, with a supplier qualification dossier ready for your QA team to review.

Your brand

Production

Agent configurations versioned and change-controlled from day one. Your quality team builds and owns their own agents via the no-code Agent Factory. Every action logged in an immutable, write-protected audit trail. PV intake, document QC, and regulatory writing: governed, with human sign-off at every step.

"In production at one of Europe's most regulated enterprise environments: every employee action logged and auditable, checks executed before actions are taken. "

ISO 27001 certifiedSOC 2 certified

Our DPO blocked general AI tools because of UK GDPR Art. 9. Why would Streetbeat ACE be any different?

Because the architecture is different, not just the contract. Health data is stripped before it reaches any external model call: reversibly, at the pipeline level, not by policy filter. Your DPO gets a technical data flow diagram showing what leaves your perimeter, in what form, and with what controls. We provide DPIA input documentation, a full Art. 28 DPA, and a subprocessor list with hosting region and transfer-impact analysis. The answer to your DPO is architectural, not a reassurance.

How does this fit into our GAMP 5 validation process?

Streetbeat ACE is governed as a GAMP 5 Category 4 configured product: not custom-developed software, not a Category 5 requiring full SDLC validation. We supply a pre-prepared supplier qualification dossier: architecture documentation, SDLC description, change-control evidence, and a shared-responsibility matrix mapped to Annex 11 clauses. Your QA team reviews our dossier and validates your intended use (IQ/OQ/PQ). The GAMP 5 assessment becomes a desktop review, not a deep audit of our architecture.

Our QP cannot sign off on AI systems they cannot audit. How does this help?

The immutable audit trail is the answer to that objection specifically. Every agent action, every model call, every human override, every configuration change is logged and write-protected at the time of creation. Your QP can interrogate what the AI did on any given date, with which agent version, and what the human reviewer confirmed. The QP does not delegate responsibility to the AI. They can audit everything it did.

Get in touch

Book a 30-minute qualification call. We will tell you whether we are the right fit, and if not, why.

Prefer to talk first

Book a 30-min call

No slide deck. No product demo before we understand your situation. We map your AI exposure, your inspection timeline, and your regulatory obligations, and we confirm whether a fixed-scope PoC makes sense. Entry is a scoped proof of concept. No multi-year commitment required to validate the value first.

Giovanni Luca Caiazzo

Go-to-Market · Streetbeat

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