The quality risk management layer for the validation lifecycle.
Risk·AI runs as a first-class system on the Qualitum platform. Outputs feed Validate·AI (revalidation triggers), Operate·AI (deviation context), and Investigate·AI (root-cause linkage) when each ships.
GAMP 5 categorisation (Cat. 1–5)
Agent-proposed category with reasoning; reviewer-assistive override.
FMEA / FMECA with S, O, D scoring
Severity, occurrence, detectability per process step; RPN auto-computed.
HACCP / HAZOP
Hazard analysis and critical control points for sterile, ATMP, and biomanufacturing.
Fault Tree Analysis (FTA)
Top-down cause analysis with citable failure pathways.
Risk-based change impact
Feeds Validate·AI revalidation triggers; updates trace graph automatically.
Quality risk register as live data
Not a controlled document. A queryable, version-aware data object.
ICH Q9(R1) critical thinking docs
Reasoning trail per risk decision - auditor-defensible.
Audit-defensible reasoning trail
Every risk decision traces back to inputs, evidence, and approver.
Shape Risk·AI before Q3.
We are accepting six design-partner customers for Risk·AI. Co-design pricing, priority feature voice, named reference status. Cohort closes June 30, 2026. Limited to QA, Validation, and Risk Management leadership at top-50 global life sciences manufacturers.
Six seats. Twelve weeks. Pre-launch pricing locked.
Design partners co-author the FMEA scoring model, the ICH Q9(R1) critical-thinking templates, and the ValGenesis iRisk migration playbook. You ship the first audited Risk·AI agent in your tenant. Named in the Q3 launch announcement.
Apply to the cohortSix questions cohort applicants ask.
iRisk is a digital form for capturing risk decisions. Risk·AI reasons risk decisions and proposes them, with the SME signing or overriding. The audit trail captures both the agent reasoning and the human decision.
For ValGenesis customers we ship a migration path: existing iRisk decisions import as data objects, the trace graph reconstructs, and you keep your historical record intact.
Same tenant. Same private deployment. Same signature. Risk·AI outputs are first-class inputs to Validate·AI revalidation scoping.
Co-designed during the cohort window. Locked at pre-launch rates through 2028. Named-reference customers receive deeper concessions in exchange for joint case-study rights.
Bi-directional connector. Existing iRisk decisions import as data objects with full provenance. New decisions can write back to iRisk for legacy-system-of-record continuity, or live entirely in Risk·AI from go-forward.
Same governance regime as Validate·AI - EU AI Act Articles 12 and 13, NIST AI RMF, ICH Q9(R1) risk-based AI lifecycle, ISPE GAMP Good Practice Guide on AI/ML. Model card per agent, signed releases, drift detection, production-data performance monitoring.
Q3 2026 GA. Pricing rebases to standard enterprise. Cohort customers remain at locked pre-launch rates with grandfathered terms. New customers join through the standard sales motion.