How Verixa keeps AI-assisted work reviewable.
Whether a customer starts with Document Control, Deviation, CAPA or another workflow, the same governance principles apply: defined intended use, bounded AI assistance, qualified human review, controlled change and traceable system interactions.
Advisory + human-in-the-loop. Verified under our SDLC; the customer validates intended use.
The controls behind MIRA
Six control areas govern how MIRA is used, classified, changed and overseen. Implementation and verification status is maintained separately for each control area.
Verification status per control area is documented in the Evidence & Validation Pack, shared with founding partners.
AI Intended Use
MIRA assists — natural-language query over your quality workflows, review-assist, and drafting, with source references provided for reviewer assessment. MIRA does NOT approve, close, sign, dispose, or release GxP records. MIRA does NOT make critical GMP decisions. A qualified human is always in the loop.
EU AI Act Positioning
Verixa MIRA is advisory with human-in-the-loop. Verixa makes no claim of EU AI Act compliance. Obligations are role-specific (provider / deployer) and obligation-specific (transparency, GPAI dependency, human oversight), phasing in 2026–2027.
Annex 22 (Draft 2025) Internal Control
Verixa treats EU GMP Annex 22 (Draft 2025) as an internal-control reference. Generative / probabilistic AI is prohibited from making — or being the sole path for — critical GMP decisions in Verixa.
Model + Prompt + Evidence Change Control
Verixa logs model name and version, system-prompt version, retrieval-corpus version, and guardrail version on every inference. Material changes go through change control.
Human Oversight
Human-in-the-loop is a workflow object, not a checkbox: decision gates, escalation paths, review events, e-signature workflow linkage, and decision evidence are captured in the audit trail.
Data + Provider Governance
AI providers — Anthropic and Azure OpenAI — are listed as subprocessors in the DPA. Customer data is not used to train shared models. Per-tenant data isolation applies.
Human review is designed to be recorded as part of the workflow rather than treated as an external checkbox. Applicable decision gates, review events and approval or electronic-signature linkages are maintained according to the workflow’s verified control scope.
Last updated: June 2026 · Reviewed by Vimal Veereshwarayya, PhD (Founder), with a CSV/CSA contractor.
Which workflow should Verixa map first?
Select one current quality process. We will show how Verixa could support it, where AI assists, where human decisions remain mandatory, and what validation responsibilities stay with your organization.