The AI-governed pharma QMS — verified under our SDLC. Customer validates intended use.
Verixa is the AI-governed quality platform for pharma and biotech — built for the regulatory world taking shape now (FDA CSA Final Guidance Feb 2026 · EU AI Act phasing in 2026–2027 · EU GMP Annex 22 Draft 2025 considered in design). MIRA, our quality copilot, is advisory only with human-in-the-loop on every GxP-critical decision. Phase 1 ships GMP Core — Document Control, Deviation, RCA, CAPA, Findings, Inspection Readiness — verified under our SDLC. The customer validates intended use.
AI Closed the Evidence Loop.
Your QMS Should Too.
GMP compliance touches manufacturing floors, distribution, and laboratories. Verixa Phase 1 focuses on GMP Core. Future phases extend across the GxP lifecycle (GCP, GVP, GDP — see Roadmap).
The New AI Evidence Gap
Five regulatory events in 12 months — Annex 22 (Draft), EU AI Act GPAI, FDA + EMA AI principles, updated FDA CSA, and the first FDA AI warning letter (Purolea Cosmetics Lab, ref. 722591, Apr 2026). Legacy eQMS audit trails don’t capture model version, prompt hash, retrieved evidence, or HITL decision.
Two Parallel Systems — Neither Closes the Loop
Your eQMS logs WHO did WHAT. Your AI tools (ChatGPT, internal LLMs) do the WHY — and don’t log it, leaving the reasoning behind each decision invisible to QA. Verixa logs the WHO + WHAT + AI’s WHY — model version, prompt hash, retrieved evidence — and refuses to act when governance evidence is insufficient.
Evidence, Generated Continuously
The G-7 evidence pack is generated continuously as work happens, not assembled retroactively before an inspection — every action captured as a first-class, inspection-defensible GxP object. Architecture-complete · in design-partner validation. (Audit-readiness depends on the customer’s intended-use validation.)
AI-Governed Quality,
End to End
MIRA surfaces gaps, captures evidence as first-class GxP objects, and keeps every action inspection-defensible — advisory only, with human-in-the-loop.
Request a DemoAI Gap Detection, with HITL
MIRA surfaces gaps in your GMP records and refuses to act when evidence is insufficient — advisory only, human accepts before any GxP impact.
Evidence as First-Class Objects
Model version, prompt hash, retrieved evidence, HITL decision, and e-signature — captured as first-class GxP objects in the audit trail.
Inspection-Defensible Architecture
The G-7 evidence pack: 13 sections aligned to GAMP 5, FDA CSA and EU GMP Annex 11/22 (Draft). Built to hold up under inspection.
GMP Core Now. The Full GxP Lifecycle Next.
Verixa ships Phase 1 — GMP Core — today. GCP, GVP, and GDP are roadmap items, not live modules. We build on customer pull, not founder push.
GMP Core
- Document Control
- Deviation
- Root Cause Analysis (RCA)
- CAPA
- Findings
- Inspection Readiness
GMP Depth
- Change Control
- OOS / OOT
- Audit Management
- Supplier Quality
- APQR
- Batch Records
- Training
- Mock Inspection
Full GxP Lifecycle
- GDP / Cold Chain
- GCP / Clinical Quality
- GVP / Pharmacovigilance
- Stability
- Environmental Monitoring (EM)
Honest About Where We Are
Verixa is pre-customer and in active design-partner validation. We don’t publish outcomes we can’t substantiate — the first named case studies follow our Phase 1 verified go-live (target Q3 2026).
In active validation
Verixa is in design-partner validation. Architecture-complete; pre-validation.
First case studies · Q3 2026
Named case studies are expected after our Phase 1 verified go-live, with written partner consent.
Founding Partner Program
A limited founding cohort shaping the AI-governance discipline for pharma.
Verixa Quality Network
Join the Verixa Quality Network — a founding cohort of QA leaders shaping the AI-governance discipline for pharma. Limited to 100 members for the founding year. Application required.
Apply to JoinFounder-Led Quality & Regulatory Services
Delivered by Navira Quality Systems — the founder-led services arm. Operated by Vimal Veereshwarayya, PhD, RAC.
Services to accelerate Verixa adoption. Founder-led consulting during design partnership: workflow scoping, validation enablement, and inspection-readiness support.
Sprint Discovery (Phase 0)
Founder-led sprint to scope workflows and surface high-risk GMP gaps.
Pilot Scoping & Mapping
Map GMP Core workflows to Verixa with clear pilot success criteria.
Validation Enablement Kit
G-7 evidence leverage — you own intended-use validation.
Inspection-Readiness Simulation
Mock inspection modeled on FDA / EMA inspection patterns.
Director-Level QA Consulting
Senior, founder-led QA — not an outsourced help desk.
Vendor-Qualification Support
Qualify Verixa and adjacent vendors inside your supplier-quality framework.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.