Smart ERP for Regulated Operations
Connect every instrument and process, monitor your whole operation in real time, and run the business on autopilot — with 21 CFR Part 11 and GxP compliance built in, and a qualified human approving every consequential step. Generated for your company by an AI, not implemented over years.
Running a regulated operation shouldn't mean watching it by hand.
In diagnostics, pharma and medical-device manufacturing, every batch, instrument reading and process step can be audited — yet most teams stitch oversight together from spreadsheets, disconnected systems, and people watching screens. It is slow, fragile, and a single gap can become a finding.
Blind spots
Instrument and equipment data sits in silos; problems are seen late.
Manual oversight
People babysit dashboards and chase results across systems.
Audit anxiety
Proving who did what, when — and that data wasn't altered — is painful.
Rigid software
Generic ERP takes years to fit, and validation is left to you.
Slow escalation
An out-of-spec result or a down line climbs the chain too slowly.
Moving rules
Regulations change; static systems fall behind between upgrades.
One AI-run system, generated for your company.
The Smart ERP is delivered as three working parts: a governed knowledge core (the Brain) that holds your single source of truth; an AI (Cyrus) that generates and runs the system and assists, checks and audits the work; and the ERP itself — process-centric, compliance-ready, and shaped to how your company actually operates. Cyrus proposes; a qualified human approves; everything is recorded.
The AI
With access to a governed knowledge core, Cyrus generates, runs, assists and audits the system — under human control.
Your operation
Process-centric and compliance-ready, generated to fit how your company actually operates.
From the instrument to the boardroom — everything in view, in real time.
Connect every instrument and system
Lab analyzers, equipment and PLCs, files and APIs — any device, by any connection method. A modern instrument connects by API; a legacy analyzer streams over serial or TCP. Every customer's setup is supported, configured to that company.- Direct result capture from analyzers (ASTM / LIS) and beyond
- Append-only, attributed to the instrument, de-duplicated on re-send
Connect · any device, any method
Watch it all, continuously — and catch problems live
A historian records every signal over time; live monitoring compares each reading to your limits and a staleness window, and flags the moment something is out of range, off, or has gone silent — then escalates up the reporting line to the responsible manager, automatically, by your org chart.
- Range, latest and min / max / average queries over your telemetry
- Per-signal high / low limits, expected states, and alarm severity
- Business KPIs & OKRs with target, owner and red / amber / green status
The AI does the work. Your people confirm and approve.
No two-year implementation, no constant module-hopping, no babysitting. The system is generated to fit your company, then runs your processes automatically — with the human firmly in the loop.
Built from your docs
The AI reads your quality system and generates the ERP — not a multi-year project.
Event cascades
An order, a result, an alarm — each triggers its whole process automatically.
Human-approved
Cyrus proposes; a qualified person approves every consequential change.
Audit-ready by design — with the evidence to back it.
Access follows your org chart and job descriptions; every consequential action is e-signed and approved by the right role; every record is attributable, contemporaneous, and tamper-evident (ALCOA+). The validation evidence regulators ask for is generated as you go — and every outbound communication passes a consent and disclosure gate before it leaves the building.
- 21 CFR Part 11
- GxP / GAMP 5
- ISO 13485
- ALCOA+ Audit Trail
- IVDR / UDI 2026
- ISO 27001-Aligned
- Batch / Lot Traceability
From your documents to a running ERP.
The AI does the work at every step — your team's job is to confirm and approve.
Share & connect
Your team shares documents and system access; instruments are connected.
Structure it
The Brain turns it into governed, verified knowledge.
Build the ERP
Cyrus generates the configuration and process models for your company.
Sign off
A qualified human approves the change package before anything goes live.
Move & verify
Legacy data is migrated, verified and reconciled.
Run it
A deterministic engine builds your system; it then monitors and runs the work.
A complete, regulated operation — in one governed system.
Data & documents
Tables, forms, views, documents and labels (UDI) — governed records with a full history.
Processes & e-signature
Workflows, rules, approvals with e-signatures, notifications and scheduling.
Instrument & equipment data
Acquisition (all formats), a process historian, and live equipment monitoring with alarms.
Quality & traceability
Serialization and track-and-trace, batch / lot genealogy, recall readiness.
Finance & costing
A fixed-core ledger, AR / AP, costing, tax and financial statements.
Access & people
Org-chart-based roles & permissions; the AI inherits the serving user's role.
Built for the most demanding, regulated operations.
A product for many customers — each gets its own AI-generated, isolated instance, shaped to how that company actually works.
- 21 CFR Part 11
- GxP / GAMP 5
- ISO 13485
- ALCOA+ Audit Trail
- IVDR / UDI 2026
- ISO 27001-Aligned
- Batch / Lot Traceability
See your operation monitored end-to-end — and running itself.
We'll show you the AI-run, audit-ready ERP we'd generate for a company like yours.