The AI-governed pharma QMS, by architecture.
Verixa logs the WHO, the WHAT, and the AI’s WHY — model version, prompt hash, retrieved evidence, and the human decision — as first-class GxP objects. Phase 1 ships GMP Core; GCP, GVP, and GDP are on the roadmap.
Architecture-complete · in design-partner validation. Verified under our SDLC; the customer validates intended use.
What “AI-governed” actually means
The differentiator is the evidence the architecture captures — not a longer feature list.
Schema-level audit trail
Model version, prompt hash, retrieved evidence, the HITL decision, and the e-signature are captured as first-class GxP objects — not free-text notes.
MIRA — advisory + HITL
The quality copilot surfaces gaps and drafts evidence, but a qualified human accepts before any GxP impact. Never autonomous in GxP-critical decisions.
G-7 evidence pack
A 13-section supplier-assurance pack generated continuously, so inspection readiness is a state — not a retroactive scramble.
GMP Core — six workflows
In design-partner validation. Each workflow runs on the schema-level audit trail with MIRA advisory + HITL.
Versioned SOPs with e-signed, controlled approvals.
Capture, triage, and investigate every excursion.
Structured RCA linked to the deviation record.
Corrective + preventive actions, tracked to closure.
Audit & inspection findings, managed in one place.
Always-on evidence, ready for any inspection.
GMP Core now. The full GxP lifecycle next.
We build on customer pull, not founder push. GCP, GVP, and GDP are roadmap items, not live modules.
GMP Core
In design-partner validation
- Document Control
- Deviation
- RCA
- CAPA
- Findings
- Inspection Readiness
GMP Depth
2027 Q2–Q4
- Change Control
- OOS / OOT
- Audit Management
- Supplier Quality
- APQR
- Batch Records
- Training
- Mock Inspection
Full GxP Lifecycle
2028+
- GDP / Cold Chain
- GCP / Clinical Quality
- GVP / Pharmacovigilance
- Stability
- Environmental Monitoring
Go deeper on the architecture
Deep dives into what makes a Verixa workflow inspection-defensible.
MIRA Copilot
Advisory + human-in-the-loop. What MIRA does — and the hard lines around GxP-critical decisions.
ExploreG-7 Evidence Pack
The 13-section, inspection-defensible evidence pack shared with every founding partner.
ExploreAI Governance
Intended use, EU AI Act positioning, Annex 22 internal control, and human-oversight design.
ExploreDesign-partner validation
Verixa is in design-partner validation. The architecture is complete and in pre-validation; founding partners shape what we harden first. We don’t publish outcomes we can’t substantiate.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.