Operational Intelligence Missions
Explore how governed AI transforms regulated operations — one mission at a time.
CRI Ops™ — Compliance Recovery Intelligence
Novulytix — a medtech & diagnostics manufacturer organized into three divisions (Cardia Rhythm Solutions, Pharma Manufacturing, Scientific Systems) — is under an FDA Warning Letter. A repeated complaint trend was judged inadequately addressed, CAPA effectiveness is asserted but unproven, and the FDA response milestone is 15 business days out. A newly appointed Chief Quality Officer needs a fast, evidence-backed read on what is actually happening across sites — and a short, prioritized list of the actions that matter most — in days, not the six weeks a full consulting bench would take.
Inspect Navigator™ — Inspection Readiness & Response Intelligence
Novulytix — a synthetic medtech & diagnostics manufacturer organized into three divisions (Cardia Rhythm Solutions, Pharma Manufacturing, Scientific Systems) — is on Day 2 of a live FDA GMP inspection (FDA-2025-0214). An investigator asks for CAPA-effectiveness evidence on the seal-integrity CAPA. The VP Quality has minutes, not hours, to assemble a cited, consistent response across systems — and the same failure mode is quietly recurring on Line 4, where the investigator is heading next. Inspect Navigator turns the inspection from a reactive coordination scramble into intelligence-driven operational confidence, with a human approving every release.
Deviation 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.
Equipment Recovery Operations
A NovaSight LX-9000 shows progressive thermal instability during analytical runs at a research institute with an active FDA-regulated study. The service team scrambles across ServiceMax, SAP, service manuals, bulletins, Teams threads, and tribal knowledge to diagnose, escalate, and recover — while the clock runs on a 24-hour SLA and 48-hour sample viability window.
Clinical Supply Chain Resilience
An optimization engine flags a projected shortage at a European depot. 42 patients across 8 sites are at risk. Compounding factors — comparator delays, temperature excursions, labeling constraints — explode across IRT, CTMS, ERP, depot systems, email, and SMS. The supply chain team needs governed recovery intelligence, not more spreadsheets.
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.
CAPA 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.
Multi-Site Coordination Intelligence
An operational event impacts three manufacturing sites simultaneously. Each site has different systems, different teams, and different processes. Coordination is manual, slow, and error-prone.
PLM DFx Risk Intelligence
The NovaPulse P-300 Infusion Pump is 47 days from design lock. 10 risk signals have surfaced across 7 subsystems — a critical CTQ traceability gap blocking IEC 62304 verification, an unvalidated CAPA transfer from the P-200 platform, and a roller pin material change with production-scale validation incomplete. 9 suppliers are in qualification, 5 are single-source. The DFX readiness scorecard shows 72% — not ready for design lock. Every design decision must be governed, traced, and audit-ready across 6 DFX pillars.