Governed AI Platform · For Pharma & Biotech Quality Teams

When the inspector asks about your AI,
this is your evidence pack.

Streetbeat is a governed AI engine built for GxP environments. You configure it around your quality team's workflows. What your QA and regulatory teams run is validated, auditable, and yours. Streetbeat stays under the hood.

Book a 30-min call
Built for environments where MHRA, EMA, and FDA ask hard questions
No model training on patient data
What the inspector sees
Enter your company name.
validation-summary-report.yaml
# Validation Summary Report document_ref: VSR-2026-001 sponsor: "Norwick Pharma Quality Ops" system_type: agentic_ai_platform gamp5_category: 4 # configurable application regulatory_mapping: annex_11: covered gdpr_art_9: health_data_governed mhra_gmp: governed evidence: audit_trail: immutable agent_versions: controlled model_training: false tenant_isolation: strict inspector_ready: true ✓
This is your AI system's evidence pack. Governed, from day one.
The problem

What the inspector finds when your AI runs without governance.

Your quality team is already using AI. Deviation triage in unvalidated tools. PV case summaries in whatever was available. Regulatory dossier prep in whatever was available. None of it has an audit trail. None of it is versioned. None of it can answer an inspector's computerised system checklist. The question is not whether to govern AI in your quality operations. It is whether you govern it before or after the inspection finding.

The scan

What is running in your quality team right now.

✗  Current state
Audit trail
✗ No record of what AI generated, from which input, or why
Health data
✗ Exits your perimeter in plaintext on every query
Validation status
✗ Not managed as a computerised system - no version control on AI outputs
Inspector documentation
✗ Not available - nothing to show an inspector who asks
✓  With Streetbeat ACE
Audit trail
✓ Immutable - every action, agent version, and output logged and traceable
Health data
✓ Reversible PII redaction - health data never reaches an external model in plaintext
Validation status
✓ GAMP 5 Category 4 compatible - agent configs versioned and promoted through defined stages
Inspector documentation
✓ Full GxP validation pack delivered with every PoC - URS, DQ, IQ/OQ documentation included
How it works

Three acts. One platform that's yours.

Act 01: Scope
Deviation Triage Protocol - v2.4
Observation
Risk class
CRIT MAJ MIN
PII redact
AI review
CAPA draft
Audit record
your SOP.
governed. ✓
We start with your quality workflows
A 30-minute call. We map two or three of your actual use cases: deviation triage, PV case intake, regulatory dossier review. We identify where governed AI pays back first and what the GxP validation scope looks like. No slides, no prepared demo.
Act 02: Configure
platform.config.yaml
# your platform, your config platform_name: "Norwick Pharma Quality AI" regulatory_scope: eu-gxp brand_primary: "#1A3A6B" gamp5_category: 4 agents: - deviation_triage - pv_case_intake - regulatory_dossier annex_11: principles_aligned health_data: reversible_pii audit_trail: immutable csv_status: qualified
Your front-end, built to your spec in 4–6 weeks
We deliver a dedicated interface configured around your quality workflows. Your brand, your agent names, your SOPs versioned inside. Test it on your own data before any broader commitment. GxP validation documentation included.
Act 03: Yours
NP
Norwick Pharma
GXP AI PLATFORM
QUALIFIED
Agents
Runs
Audit
Versions
Deviation Triage
● Qualified
PV Case Intake
● Qualified
Regulatory Dossier
● Qualified
Engine: Streetbeat ACE · Validated. Yours.
You own it. Your Quality team extends it.
Production deployment. What your QA and regulatory teams run is your platform, under your name, with your SOPs encoded. Your quality managers extend the agent library as your regulatory obligations evolve, without an engineering cycle.
Governance

The engine beneath is already in production at regulated enterprises.

Versioned agent configurations. Immutable audit trail. Reversible PII redaction that keeps health data out of external models. Per-tenant isolation. The governance layer is part of the architecture. Not bolted on. Every agent action is traceable to the specific version, the input, and the operator who triggered it.

Your DPO asks different questions than your Quality Director does. We have documentation for both. GxP validation pack available under NDA at any stage of evaluation.

ISO 27001
SOC 2
Compatible with Annex 11 / GAMP 5
gxp-audit.log
# GxP Validation Record client_id: np_4c1d8b_norwick platform_name: "Norwick Pharma Quality AI" agent_version: deviation-triage@v2.4.1 qualified_at: 2026-06-19T09:14:22Z validation: gamp5_category: 4 annex_11: principles_aligned health_data: reversible_pii model_training: false audit_trail: immutable tenant_isolation: strict run_count_7d: 412 last_run_status: success inspector_ready: true ✓
Questions

What Quality Directors ask before they commission.

Can deviation records, PV case files, and health data go through this without UK GDPR Art. 9 exposure?
That is the specific constraint the platform was designed around. Reversible PII redaction strips health data before anything reaches an external model. Your DPO can review the data flow architecture under NDA. Per-tenant isolation means each engagement runs in a separate data lane. We never train models on your data. The architecture enforces it, not a policy document.
What does "compatible with Annex 11 / GAMP 5 principles" mean for an inspection?
Agent configurations are version-controlled and promoted through defined stages, which maps to how GxP expects computerised systems to be managed. Every agent action produces an immutable, traceable audit record. We provide a GxP validation pack (URS, DQ, IQ/OQ documentation) as part of the PoC delivery. This is not a wrapper; it is how the system was built. We do not claim certification. That is your Quality team's call after review.
When our team adds a new agent, does it require a full revalidation cycle?
Agent Factory is built on the same versioned, auditable infrastructure as the core platform. New agents inherit the governance architecture. The scope of validation for an incremental agent addition is significantly smaller than a standalone system validation. We document this in the PoC. Your Quality team retains sign-off authority on every agent version that goes to production.
How do you respond to board-level questions about AI risk?
Every inference is logged, every model version is pinned, and every output carries a human sign-off before it leaves the system. That is the audit trail your board and your insurers need.
Get in touch

Tell us your quality team's biggest AI blocker. We will show you what a governed, validated platform built around it looks like.

Book a 30-min call

No slides. We map two or three of your quality workflows and tell you honestly what the PoC scope, cost, and GxP validation effort look like.

GL
Giovanni Luca Caiazzo
Go-to-Market · Streetbeat
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