Control and evidence layer for AI agents in regulated life sciences

Omphyr sits between an AI agent and the systems that hold GxP records, such as a LIMS, QMS or ELN. Each action the agent tries to take is checked against your written policy before it runs. Anything that needs a person’s decision is held for sign-off. Every decision goes into a signed, tamper-evident record that names both the agent and the person it acted for.

It runs in your own environment; nothing leaves it. Built to the requirements of EU GMP Annex 11 and the draft Annex 22, with a validation support pack. Omphyr Ltd is SOC 2 attested.

For organisations putting AI to work in GxP operations, and for AI developers whose agents need to pass a QA review. Pilots start in observe mode, so nothing changes in your operation while the record is built.