AI Lab Services

Architecture

Built to be provable.
Not just trustworthy.

Every architectural decision in AILS was made to be verifiable — by your auditor, your security team, and your regulator. Not just described in a whitepaper. Proven in 1232 automated tests and live in production.

112
AI Agents
1232
Automated Tests
102
Test Suites

Five-layer architecture

Each layer has one job. Each layer is testable in isolation. Each layer is documented in the test suite.

01

AI Orchestration Layer

112 purpose-built agents — each scoped to one specific job, operating on live tenant data. No generic assistants. Every agent is purpose-built for its task with model selection optimized per workflow.

Quality checkingRegulatory investigationRisk assessmentCompliance reviewDocument generationValidation co-pilotSelf-auditQC review
02

Governance & Compliance Layer

Every workflow enforced at the code layer — not configured, not hoped. Re-authentication gates, training gates on signing and issuing, tamper-evident records, and approval chains built into every mutation.

Re-authentication on COA issue, SOP sign-off, COC acceptanceExpired training blocks the five signing and issuing actions at the API (not warns)SHA-256 lock on every issued certificateManager override workflow with re-auth requirementSeparation of duties on SOP creation vs. approval
03

Data & Operations Layer

LIMS, QMS, ELN, inventory and billing in one codebase. Every feature built as a regulated workflow, not a CRUD form.

COC / COA pipeline with traceability chainEquipment calibration + metrological traceabilityCAPA + deviation + complaint + internal audit workflowsInvoicing with item linkage to COC/COA recordsCustom fields, departments, saved filters, notification prefs
04

Security & Isolation Layer

Every query scoped to the tenant ID. Secrets encrypted at the application layer. Multi-factor authentication. A tenant isolation suite run every release.

Every query scoped to the tenant ID — dedicated database for bring-your-own-database and EU tenantsApplication-level encryption of connection strings, tokens, API keys, and 2FA secretsMulti-factor authentication with recovery codesShort-lived access tokens with refresh rotationTenant isolation suite run every release
05

Infrastructure Layer

Separate hosting for API, frontend and marketing site. EU data residency available. Purpose-built agents, model-optimized per workflow.

Separate API and frontend deploymentsEU data residency optionTenant-scoped data isolation at the database layerPurpose-built AI agents, model-optimized per workflow
Always-On Health Monitoring

Monitors itself 24/7.
Humans approve every fix.

AILS watches itself 24/7. When something needs attention, it tells you what it found, what it recommends, and waits for your approval. When any of the 112 AI agents detects a failure — malformed output, timeout, low confidence score — it files an internal diagnostic ticket automatically.

The platform diagnoses the root cause and proposes a fix. Human approval is required before any code is committed. Safety boundaries — authentication paths, middleware, audit trail — are hardcoded exclusions that no automated pipeline can touch.

1

Agent detects failure

Malformed output, timeout, or quality below threshold triggers an internal diagnostic report

2

Ticket auto-filed

Diagnostic ticket created with agent context, route, input, error, and severity

3

Root cause diagnosed

The platform reads the source, identifies the issue, and proposes a fix

4

Human reviews & approves

Platform admin sees the proposed fix, reviews, and approves before deployment

5

Fix deployed & verified

Change deployed, agent health suite re-runs to confirm the failure is resolved

Design decisions — and why

Every non-obvious architectural choice has a documented reason. These are the ones we get asked about most.

Tenant ID scoped into every query, verified by an isolation test suite

Row-level filtering can fail under load, be bypassed by ORM bugs, or be misconfigured in migrations. Every query carries the tenant ID from the authenticated session, and an isolation suite attempts cross-tenant reads on every release to catch the case where it was left out. A tenant that needs its data held separately gets a dedicated database through bring-your-own database or EU hosting.

Re-authentication at every critical signing event

A logged-in session is not signature authority under 21 CFR Part 11 §11.200. An attacker with a stolen session token cannot issue COAs, sign SOPs, or accept COCs.

Block signing and issuing on expired training, not a warning

Warning-and-proceed is not compliant with 21 CFR and CLIA training requirements. A hard block on the five signing and issuing actions forces the issue — management must act, not dismiss a banner.

AI agents built into workflows, not bolted on

A generic AI assistant has no context about your specific lab, tenant data, or regulatory state. Each of 112 agents reads your live records and operates within your governance controls.

Health monitoring: the platform watches itself

Users often don't report intermittent failures. When an agent detects a malformed output, it files an internal ticket with full diagnostic context. A human reviews and approves every fix before deployment.

SHA-256 on COA issuance, not just role-based edit lock

Role-based locks can be bypassed by admin credential compromise or DB direct access. A SHA-256 hash computed at issuance and stored in the record is verifiable by your auditor independently.

See the architecture running.

Every decision above is live in production. The test suite proves it.

See it work →View the test results →