The AI-governed quality platform for regulated life sciences.
One shared governance foundation behind every workflow — keeping workflow records, AI-assisted outputs, relevant source context, human review and applicable approval events connected under one customer-defined scope. Start with one workflow. Add related workflows without rebuilding the governance foundation each time.
Built for quality teams under real regulatory scrutiny
For teams facing FDA and EU inspection exposure that need inspection-grade evidence from day one — without an enterprise implementation program to get there.
Mid-market pharma manufacturers
GMP manufacturers running one or a few sites — real inspection exposure, without an enterprise QMS budget or program.
CDMOs
Contract manufacturers under both client audits and regulatory inspections — one evidence trail that answers to both.
CROs
Contract research organisations accountable to sponsor quality oversight across studies and sites.
What governed AI means inside a Verixa workflow
The differentiator is the evidence the architecture captures — not a longer feature list.
Schema-level audit trail
The architecture is designed to preserve the relevant model or deployment identifier, system configuration, source context, generated output and reviewer disposition as structured records — not free-text notes — according to each workflow's implemented and verified control scope.
MIRA — advisory + HITL
MIRA may surface gaps and draft workflow content for qualified human review; a qualified human accepts before any GxP impact. Never autonomous in GxP-critical decisions.
Evidence & Validation Pack
A structured supplier-assurance pack organised as work progresses, so evidence for QA review and inspection preparation is not assembled retroactively.
The differentiation is not a longer module list. It is keeping AI assistance, human accountability and workflow evidence connected in the same process.
GMP Core — Manufacturing · five workflows
In Design-Partner Validation. Each scoped workflow uses the applicable Verixa governance controls — audit trail, MIRA advisory + HITL — according to its implemented and verified control status.
Document Control
Versioned SOPs with controlled approvals (e-signature controls under verification).
Deviation Management
Capture, triage, and investigate every excursion.
Root Cause Analysis
Structured RCA linked to the deviation record.
CAPA Management
Corrective + preventive actions, tracked to closure.
Inspection Readiness
A sealed, tamper-evident inspection evidence pack assembled from live records — scorecard, exceptions summary, and one-click audited export.
Start with one workflow. Expand when the operating value is clear.
We build on customer pull, not founder push. GCP, GVP, GDP, and GLP are roadmap items, not modules in the current scope.
GMP Core
In Design-Partner Validation
- Document Control
- Deviation Management
- Root Cause Analysis
- CAPA Management
- Inspection Readiness
GMP Depth
2027 Q2–Q4
- Findings
- Change Control
- OOS / OOT
- Complaints
- Audit & Inspection Management
- Supplier Quality
- APQR
- Batch Records
- Stability
- Environmental Monitoring
- Training
- Risk Management
- Equipment & Calibration
Full GxP Lifecycle
2028+
- GDP / Cold Chain
- GCP / Clinical Quality
- GVP / Pharmacovigilance
- GLP / Nonclinical Laboratory Quality
Go deeper on the architecture
Deep dives into how a Verixa workflow keeps its evidence organised for QA review and inspection preparation.
MIRA — Quality Copilot
The product behaviour.
Advisory + human-in-the-loop. What MIRA does — and the hard lines around GxP-critical decisions.
Evidence & Validation
The proof artifacts.
The structured supplier-assurance evidence pack shared with every founding partner.
AI Governance
The framework.
Intended use, EU AI Act positioning, Annex 22 internal control, and human-oversight design.
Your records, defensibly held
Access & authority
Role-based authority gates and segregation-of-duties controls are enforced at the platform layer, not by convention.
Evidence integrity
Exported evidence packs are sealed with a verification hash bound to the pack identity and disposition timestamp — tamper-evident by construction.
Compliance posture
Built against 21 CFR Part 11 / EU Annex 11 expectations for e-records and e-signatures (e-signature controls under verification; validation posture documented in the Evidence & Validation Pack).
Hosting & data residency
Per-tenant isolation on AWS — US-East for US tenants, Mumbai for India tenants — DPDP-aware, with data residency kept to your region.
Design-partner validation
Phase 1 is in design-partner validation; founding partners shape what we harden first.
We don’t publish outcomes we can’t substantiate.
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.