Governed Operational Intelligence for Pharma
Transform deviation investigations, CAPA management, and audit readiness with explainable AI that understands regulated pharmaceutical operations.
Key Pain Areas
Relevant Missions
Audit Readiness Intelligence
An FDA inspection is announced. The compliance team has 48 hours to assemble evidence across quality systems, deviation records, CAPA logs, and training documentation.
quality opsCAPA Orchestration Intelligence
A recurring deviation pattern requires corrective action. But the CAPA process is buried in paperwork, disconnected from root cause evidence, and impossible to track across sites.
quality opsDeviation Investigation Intelligence
Novulytix — a medtech & diagnostics manufacturer organized into three divisions (Cardia Rhythm Solutions, Pharma Manufacturing, Scientific Systems) — detects a seal-integrity deviation on Cardia Rhythm Solutions' Waukegan Line 4. The clock starts: initial assessment in 24 hours, full investigation on a committed timeline. The QA Manager must assemble evidence across batch records, environmental data, and equipment logs, identify root cause, and link a CAPA — while recurrence mapping reveals the same failure mode already closed on Line 2 on training-completion alone. Deviation Investigation turns a tribal-knowledge scramble into governed intelligence, with a human approving every step.