Office Address

123/A, Miranda City Likaoli
Prikano, Dope

Phone Number

+0989 7876 9865 9

+(090) 8765 86543 85

Email Address

info@example.com

example.mail@hum.com

What are you looking for?

Automate Deviation Intake and Risk Scoring — Stay Audit-Ready

Detect deviations early, classify risks accurately, escalate intelligently. Built for FDA, EMA, and ICH inspection survival.

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What Is Deviation & Risk Triage?

Verixa’s Deviation & Risk Triage module ensures that no deviation goes undetected, no risk goes unmeasured, and no audit readiness gap is left open.

Automated intake, FMEA-driven risk scoring, and real-time escalation—all audit-traceable and GxP-aligned.

AstraX
AstraX

How It Works

  1. User submits a deviation or the system detects deviation intent.
  2. Verixa auto-collects critical metadata: product, GxP domain, phase, impact.
  3. AI classifies severity: Critical / Major / Minor.
  4. Runs FMEA-based Risk Scoring (Severity × Probability × Detection).
  5. Applies intelligent escalation routing:
    • High Risk: Escalate to QA Head
    • Medium Risk: Notify QA Manager
    • Low Risk: Log for trending only.
  6. All events logged for full audit trail.

Why It Matters

  1. Slash deviation intake time by 60–80%.
  2. Ensure no minor deviation snowballs into a regulatory finding.
  3. Prioritize responses by risk—not by guesswork.
  4. Deliver a traceable, defensible inspection record.
AstraX
AstraX

Core Features

  1. Intelligent Deviation Intake Structuring – Collects full deviation metadata with mandatory field enforcement.
  2. Automated Severity Classification – Critical → Major → Minor routes set by deviation characteristics.
  3. FMEA-Based Risk Assessment – Calculates RPN (Risk Priority Number) dynamically.
  4. Intelligent Escalation Logic:
    • High RPN (>121): QA Head escalation
    • Medium RPN (81–120): QA Manager notification
    • Low RPN (≤80): Trend logging.
  5. Full Audit Trail + Validation Logs – Every intake, triage, escalation decision is timestamped, rationale-recorded, and ERES-compliant.

Compliance and Validation

Verixa’s Deviation & Risk Triage is validated against:

  • 21 CFR Part 11 (Electronic Records & Signatures).
  • EU GMP Annex 11 electronic traceability standards.
  • ICH Q9 Risk Management frameworks.
  • Structured intake and risk-scoring aligned to regulatory inspection expectations.

Zero gaps. Zero undocumented risks. 100% audit-ready.

Automated intake, FMEA-driven risk scoring, and real-time escalation—all audit-traceable and GxP-aligned.

AstraX