Governed AI for Regulated Manufacturing
LLMOps.Pro builds AI tools that a GxP auditor can trust: grounded in your own documents, governed by explicit rules, and audit-logged end to end. Founded by Mauro Moro, a pharma automation & CSV engineer with 25+ years on the plant floor.
Products
One product ready for regulated teams today, and the open standard and engineering practice behind it.
ComplianceGxP
The AI co-pilot for GxP compliance authoring. Drafts CSV protocols, deviation investigations, and CAPAs from your own SOPs, with source citations on every answer, a tamper-evident audit trail, and a ready-to-execute IQ/OQ/PQ package for your qualified environment.
AgentContract
Behavioral contracts for AI agents: what an agent must, must not, and can do, checked on every run. Python, TypeScript, and Rust implementations. It is the governance layer inside ComplianceGxP.
Simumation.pro
Remote 3D layout simulation, cycle-time audits, and virtual commissioning with RoboDK and RobotStudio, for automation projects before they reach the plant floor.
Three Properties Every Product Must Have
In regulated life sciences, an ungrounded or unverifiable model isn't a feature — it's an audit finding.
Grounded
Answers come from the customer's own approved documents, and every answer shows its source. When the documents don't contain the answer, the product says so instead of guessing.
Governed
Written rules define what the AI must, must not and can do, and they are checked on every run with the open AgentContract standard. The AI drafts; a qualified person reviews and signs.
Auditable
Every question, source and answer is written to a tamper-evident log, so a reviewer can check afterwards exactly what happened. How ComplianceGxP does it →
You Work With the Engineer Who Built It
I'm Mauro Moro. I spent 25+ years in pharma automation, MES/SCADA, and computerized system validation, on real plant floors and through real FDA and EMA inspections. LLMOps.Pro is my company: there is no sales team between us. When you talk to LLMOps.Pro, you talk to me.
Projects for life sciences and medical technology manufacturers, including:
Past project experience from my engineering career. These companies are not ComplianceGxP customers.
Let's Talk
Evaluating AI for your validation or quality team? Tell me what you're working on and I'll reply personally, usually within two business days.