A single system of record for AI in regulated environments — every use case inventoried, risk-assessed, approved, and backed by an audit-ready trail. ISO/IEC 42001-style management-system thinking keeps assurance alive beyond a one-time assessment.
Inventory the AI
A central register of use cases, attributes, and status — plus Agent / Skill Cards to author, version, attest, and link trust contracts.
Score the risk
A Risk Engine for attribute-based scoring and tiering, a version-controlled Risk Taxonomy, regulatory mapping per use case, and vendor & model evaluation.
Control the lifecycle
Configurable intake and approval with ownership and recorded decisions, plus a versioned policy library with applicability.
Prove it
21 CFR Part 11 audit trail, e-signatures, attribution, and retention — evidence as a byproduct, not a scramble.
As teams adopt AI, they must show an inventory of AI systems, the rationale behind each risk classification, and control evidence — testing, monitoring, and incident logs. GenariOne makes that evidence a byproduct of how AI is governed.
Agents assist, suggest, and adapt so your teams stay in control with explainable AI.
GxP by design. Aligned with ALCOA principles, GAMP 5, and FDA CSA Guidance.
Full traceability, signature verifaction, audit trailed and 21 CFR Part 11 compliant.
