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?

Instant Export. Complete Audit Trails. Total Compliance Confidence.

Export structured compliance records, deviation histories, RCA rationales, and CAPA outcomes—fully audit-traceable, instantly inspection-ready.

BOOK A LIVE DEMO

What Is Export & Audit Mode?

Verixa Copilot’s Export & Audit Mode transforms every interaction—deviation intake, RCA investigation, CAPA closure—into a structured, exportable record ready for regulatory inspection.

Whether preparing for a 21 CFR Part 11 audit, an EMA inspection, or internal quality review, Verixa delivers complete audit bundles, validated logic trails, and inspection artifacts instantly.

AstraX
AstraX

How It Works

  1. Capture everything: each query, deviation, RCA decision, and CAPA action is logged.
  2. Initiate Export Mode to compile compliance datasets by:
    • Module (Deviation, Risk, RCA, CAPA)
    • User or Site
    • Time window
  3. Generate export files in multiple formats:
    • PDF
    • JSON
    • CSV
  4. Exports are sealed with ERES-compliant digital signatures.
  5. Snapshots are instantly ready for audit rooms, regulatory submissions, or sponsor reviews.

Why It Matters

  1. Slash audit preparation time from weeks to minutes.
  2. Instantly produce complete, regulator-ready evidence packages.
  3. Defend every decision with documented logic trails.
  4. Eliminate missing records, incomplete RCA rationales, or CAPA gaps.
  5. Prove operational compliance, not just documentation compliance.
AstraX
AstraX

Core Features

  1. One-Click Compliance Record Export – Export deviation logs, RCA maps, CAPA outcomes, and risk assessments with a click.
  2. Structured Audit Logic Trees – Every RCA and CAPA shows causal mapping, reasoning steps, and escalation logic.
  3. ERES-Compliant Digital Signatures – 21 CFR Part 11 signature validation on all exported artifacts.
  4. Multi-Format Download Options – JSON for integrations, PDF for audit binders, CSV for analysis.
  5. Secure Export & Access Controls – Only authorized QA, RA, and Compliance Officers can export artifacts.

Compliance and Validation

Export & Audit Mode ensures:

  • Compliance with FDA 21 CFR Part 11 electronic record standards.
  • Adherence to EU GMP Annex 11 audit trail and export requirements.
  • Alignment to ICH Q9 (risk logic) and ICH Q10 (CAPA system traceability).
  • Immediate readiness for regulatory inspection demands.

Everything traceable. Everything defensible. Everything instant.

AstraX