Instant, Audit-Ready GxP Answers — Powered by Verixa Copilot
Ask any compliance question—get validated, regulation-backed answers instantly. Traceable, audit-ready, and aligned with FDA, EMA, and ICH expectations.
BOOK A LIVE DEMOWhat Is Verixa Q&A Assistant
Verixa’s Q&A Assistant transforms how GxP teams interact with compliance information. Unlike generic AI chatbots, it structures every query against regulatory frameworks, detects deviation risks, and maintains a full audit trail—ensuring you stay inspection-ready at every step.
How It Works
- User submits a free-text compliance-related query.
- AI classifies intent, tags GxP domain, detects deviation signals.
- If standard: Instant, citation-backed regulatory answer delivered.
- If deviation or unclear: Escalates to QA or SME review.
- All queries, actions, and answers are audit-logged automatically.
Why It Matters
- Saves hours lost manually searching SOPs, regulations, and QMS libraries.
- Proactively detects deviations from user queries — closing hidden risk gaps.
- Provides inspection-ready records with full audit traceability.
- Escalates unclear or high-risk queries before a mistake becomes an audit finding.
Core Features
- Intelligent Metadata Structuring – Captures GxP domain, deviation signals, language, and escalation path automatically.
- Regulation-Backed Instant Answers – Maps each response back to validated regulatory standards (FDA, EMA, ICH) and your SOPs.
- Deviation Detection and Escalation – Automatically identifies deviation-related queries and triggers the correct internal workflows.
- Audit-Grade Traceability – Logs every interaction, including query details, AI confidence score, and routing decisions.
- Human-in-the-Loop Assurance – If confidence is below 85%, the system flags and escalates the task to human QA reviewers.
Compliance and Validation
Verixa Copilot’s Q&A Assistant ensures:
- Full audit trail capture compliant with 21 CFR Part 11 and EU GMP Annex 11.
- Deviation signals flagged proactively based on operational risk analysis.
- Transparent escalation paths and user-actionable records.
- Zero undocumented decision-making at any user interaction point.