Enclavia AI Governance Solution

The Security Manager for Your AI Agents

An end-to-end AI governance and assurance platform that operationalizes ISO 42001 and AIUC-1 — giving agentic workers the background checks, supervision, and performance reviews that human employees already have. AI agents now do employee-grade work, but without employeegrade oversight. They consume data, draw conclusions, and take actions — often with no manager, no review, and no accountability.

Enclavia.ai supplies the missing management layer: a control plane that sits between your agents and the systems they touch, enforcing policy (ISO 42001) and continuously verifying behavior (AIUC-1).

ISO 42001 POLICY ENGINE AIUC-1 CONTINUOUS TESTING

CFR PART 11 / ANNEX 11 SOC 2 · HIPAA · FEDRAMP-ALIGNED

MULTI-AGENT ORCHESTRATION The Employee Analogy, Made Technical

Human worker control Agentic equivalent Enclavia.ai component Background check before hire Model & tool vetting before deployment

Agent Registry + Pre- Deployment Eval Gate

Onboarding & training Policy binding, guardrail config, grounding

ISO 42001 Policy Engine

Manager reviewing work Real-time action inspection & authorization

Runtime Supervisor (PEP/PDP)

Quarterly performance review Recurring adversarial & reliability testing

AIUC-1 Assurance Engine

HR file / accountability record Immutable audit trail of every decision

Compliance Ledger (Part

End-to-End Architecture

Every agent action flows through five planes. Requests are admitted only after policy evaluation; actions are logged immutably; and the same agents are continuously retested out-of-band against AIUC-1 controls.

CONSUMERS

AI Agents / Copilots Internal Apps & APIs Human-in-loop UI External Partners (SaMD clients)

RUNTIME CONTROL PLANE (Security Manager)

Policy Enforcement Pt

Intercepts every prompt, tool call & action Allow · Block · Redact · Escalate

Guardrails Layer

PII/PHI redaction Prompt-injection filter Hallucination / grounding check

Policy Decision Pt

ISO 42001 rules + RBAC scope / authorization least-privilege checks

Orchestration / MCP Broker

Multi-agent routing Scoped tool & data tokens POWER methodology

GOVERNANCE PLANE — ISO 42001 (the job description)

AI Policy Engine Agent Registry

Risk Register / Impact Model & Tool Vetting

ASSURANCE PLANE — AIUC-1 (the review)

Adversarial Test Harness Red-Team / Jailbreak

Reliability Scorecards Drift & Eval Monitor

EVIDENCE & DATA PLANE Compliance Ledger

Immutable · 21 CFR Part 11

Audit & e-Signature Annex 11 · WORM logs

Grounded Knowledge

RAG · provenance · lineage

Evidence Exporter

Auditor & buyer packets binds policy continuous tests logs every decision Solid = request/enforcement path · Gold dashed = out-of-band assurance & evidence path

Component Detail Runtime Supervisor

(PEP/PDP)

An inline gateway proxying all agent traffic. Every prompt, tool call, and action is intercepted and evaluated against bound policy before execution — the literal "manager reviewing the work." Decisions: allow , block , redact , escalate-to-human .

Sub-50ms p95 target so it stays transparent to the agent.

Guardrails Layer

Stacked detectors: PII/PHI redaction, prompt-injection and jailbreak classifiers, output grounding/citation checks against the knowledge store, and toxicity/policy filters. Catches the failure modes SOC 2 and ISO 27001 were never built to evaluate.

ISO 42001 Policy Engine

The job description. Declarative policies (YAML/OPA-style) define what each agent class may do, which data it may touch, and required human checkpoints.

Maps to ISO 42001 Annex A

controls and exports the AI

Management System (AIMS)

documentation set.

AIUC-1 Assurance

Engine The quarterly performance review. Runs scheduled and eventtriggered adversarial test suites — hallucination, prompt injection, data exfiltration, authorization escape — producing pass/fail scorecards mapped to AIUC-1 controls, which themselves extend ISO 42001.

Agent Registry & Vetting

Gate Background check before hire: no agent reaches production until its model, tools, and data scopes are registered, risk-rated, and cleared through a pre-deployment eval gate.

Compliance Ledger

Immutable, append-only record of every decision, input hash, output, and approver — satisfying 21 CFR Part 11 / Annex 11 audit-trail and e-signature requirements. The agent's permanent HR file. Oneclick evidence packets for auditors and enterprise buyers.

How a Single Action Flows

# Step Plane

Agent attempts a tool call (e.g., "issue refund to

Supervisor intercepts; Guardrails scan input for injection

& PHI

PDP checks ISO 42001 policy + RBAC scope; refund

exceeds limit → escalate Runtime / Governance

Human approver confirms; e-signature captured Human-inloop

Action executes via scoped MCP token; output grounding

Full decision chain written to Compliance Ledger Evidence

7 Same scenario re-run nightly by AIUC-1 harness; scorecard updated Assurance Phased Rollout — Matches the "Stepping-

Stone" Path Phase 1 · Policy

Stand up the internal AI usage policy in the Policy

Engine. Deploy

Supervisor in observe-only mode

Phase 2 · ISO

42001 Formalize the AIMS, risk register, and Annex A controls. Switch Supervisor to

Phase 3 · AIUC-

Activate continuous adversarial testing and reliability scorecards. Export buyer-trust to map current agent behavior. Weeks 1–4. enforce. Generate certification-ready documentation. Months 2–4. evidence packets. Months 4–6.

Why this matters now. EY found that 64% of companies above $1B in revenue have already lost more than $1M to AI-related failures. The gap between deployment speed and security maturity is widening. Enclavia.ai closes it by making governance a runtime property — not a quarterly afterthought.

Deployment & Integration Form factors: SaaS, single-tenant VPC, or FedRAMP-aligned GovCloud isolation. Integration: drop-in proxy for LLM/agent traffic; native MCP broker; SDKs and OpenAI/Anthropic-compatible endpoints — no agent rewrite required.

Identity: SSO/SAML, OIDC, SCIM; per-agent service identities with leastprivilege scoping. SaMD posture: architected as Software as a Medical Device, supporting the FDA 510(k) pathway for clinical-grade deployments. Enclavia.ai — The compliance-native AI operating system for regulated industries.

Fairfax, Virginia · US & India · Technical Solution Brief