Iridius offers an execution layer that translates regulatory standards, SOPs, and internal policies into machine‑readable compliance logic and embeds it directly into AI‑driven workflows. The platform orchestrates actions across heterogeneous systems, automatically generating continuous, tamper‑evident audit evidence and supporting human‑in‑the‑loop reviews to keep AI operations within GxP‑regulated constraints.
Funding
Funding not disclosed
Founders
Product
Problem
Regulated industries such as pharmaceuticals, medical devices, and clinical research must adhere to complex safety, GxP, and regulatory standards, yet their AI initiatives often stall because existing tools lack integrated compliance enforcement and generate audit evidence only after deployment.
Solution
Iridius provides an execution layer that converts regulatory standards, SOPs, and internal policies into machine‑readable compliance logic. This logic is embedded directly into AI‑powered workflows, orchestrating actions across disparate systems while automatically capturing traceable, audit‑ready evidence as the processes run. The platform’s patent‑pending agentic architecture coordinates human‑in‑the‑loop reviews, approvals, and governance steps, ensuring every AI operation remains within defined compliance constraints without manual overlays. Continuous evidence generation eliminates point‑in‑time validation, reducing risk and accelerating validation, submission, and production timelines for regulated AI applications.
Target Audience
Primary customers are pharmaceutical, biotech, medical device, and clinical research organizations that need to deploy AI within GxP‑regulated workflows, as well as compliance and risk teams responsible for audit readiness.
Features
- Knowledge Engine that consolidates and transforms regulations and policies into structured, executable compliance logic, exposing overlaps and gaps
- Intelligent Solution Factory with agentic orchestration that embeds compliance controls, approvals, and governance at the point of execution across heterogeneous systems
- Automatic generation of continuous, tamper‑evident audit trails and evidence during workflow execution
- Human‑in‑the‑loop review and approval routing integrated into the automated workflow
- API‑driven integration with safety, pharmacovigilance, regulatory submission, clinical development, and internal AI environments
- Patent‑pending architecture designed for GxP‑regulated settings, enabling scalable compliance‑by‑design for enterprise AI