The Cognitive Brain Powering Your Quality Systems

Add intelligence to your existing QMS. From deviation intake to audit readiness — Verixa supercharges compliance, without disrupting validation.

Cognitive Brain Narrative

Quality systems today are rigid, reactive, and slow.
Regulators demand dynamic risk management, deeper investigations, and traceable actions.
Legacy QMS systems record events — but they can't reason through them.

Verixa changes the game.

Powered by Generative AI, Deep Cognitive Reasoning, and Retrieval-Augmented Generation (RAG),
Verixa transforms your compliance workflows into a living, thinking, audit-ready system.

No rip-and-replace.
No revalidation required.
No IT bottlenecks.

Just pure cognitive intelligence layered atop your current QMS.

How Verixa Works

From semantic intake to predictive CAPA, Verixa transforms quality events into inspection-ready outcomes.

Every step audit-logged.
Every critical decision human-validated.
Every export instantly inspection-ready.

Step 1: Semantic Deviation Intake

Verixa understands free-text issues, classifies severity, enforces metadata

Step 2: Dynamic Risk Scoring

Verixa understands free-text issues, classifies severity, enforces metadata

Step 3: Impact Evaluation

Patient, Product, Data, Regulatory, Operational criticality aggregation triggers escalation.

Step 4: Cognitive RCA

Guided root cause analysis with RAG-grounded evidence retrieval.

Step 5: Predictive CAPA Drafting

Dynamic action suggestions mapped to applicable regulatory clauses.

Step 6: Audit Simulation & Readiness Forecasting

Predict audit gaps, auto-generate pre-inspection action plans.

Step 7: Emergency Continuity Mode

Auto-switch to manual compliance workflows during AI/system downtime.

Core Modules

Cognitive Deviation Intake

Semantic intake & classification

Deviation metadata enforcement

Dynamic FMEA Risk Engine

Context-aware risk scoring

RAG-based recalibration

Multi-Domain Impact Aggregation

Patient, Product, Data, Regulatory, Operational domains

Criticality aggregation & escalation logic

RAG-Grounded RCA Engine

Structured RCA (5 Whys, Fishbone, Fault Tree)

RAG-validated causal evidence

Predictive CAPA Generator

Regulation-mapped CAPA suggestions

Effectiveness tracking & closure monitoring

Audit Simulation & Readiness Module

Predictive audit checklist generation

Audit vulnerability mapping

Readiness scoring

Emergency Compliance Continuity

Manual fallback workflows during outages

Full post-recovery reconciliation

Regulatory Compliance Defense

No rip-and-replace.
No revalidation required.
No IT bottlenecks.

21 CFR Part 11

Electronic Records & Signatures

EU GMP Annex 11

Traceability and Auditability

ICH Q9

Risk-Based Decision Making

ISO 13485

Medical Devices Quality Compliance