Workflow-first quality platform · Phase 1 · In Design-Partner Validation
Governed AI for regulated quality workflows.
Quality work still gets fragmented across documents, email, spreadsheets and disconnected systems. AI adds another challenge when its source context and reviewer decisions sit outside the controlled workflow. Verixa lets you start with one scoped GMP workflow — Document Control, Deviation, RCA, CAPA or Inspection Readiness — bring bounded AI assistance inside defined human-review gates, and keep the work, source context and reviewer disposition connected.
Where regulated quality work starts to break
Three problems show up in almost every regulated quality team.
Fragmented workflow evidence
The event, investigation, supporting documents and final decision often live in different places. QA spends time reconstructing context instead of reviewing it.
AI outside the quality process
Teams are beginning to use general-purpose AI tools, but the source context, generated output and reviewer disposition may not remain connected to the regulated workflow. The record cannot show how AI participated.
Too much change for one broken workflow
Improving one quality process should not require starting with a full-suite system replacement. Verixa lets teams begin with a bounded workflow and expand from there.
AI assists. Humans decide.
The record shows both.
Verixa is designed so the workflow record carries its AI provenance — what assisted, the relevant source context, and what the qualified human decided — inside the workflow that produced it. A conventional records system tells you who did what; Verixa is designed so the record also shows how AI participated.
Request a Workflow WalkthroughAssist
MIRA can surface missing context, organise cited source material and draft workflow content for qualified human review.
Review
Qualified reviewers remain responsible for accepting, modifying or rejecting AI-assisted content and for regulated decisions and approvals.
Preserve
Verixa is designed to keep relevant source context, system output and reviewer disposition connected to the workflow record.
Prepare
Supplier and workflow evidence is designed to be organised into the Evidence & Validation Pack to support customer QA review, validation planning and inspection preparation.
Start with one workflow. Expand when the operating value is clear.
Phase 1 focuses on GMP Core. GCP, GVP, GDP and GLP are roadmap items, introduced only after intended use is defined, implementation and verification are complete, and commercial release is approved.
GMP Core
- Document Control
- Deviation
- Root Cause Analysis (RCA)
- CAPA
- Inspection Readiness
Evidence & Validation Pack accompanies every workflow.
GMP Depth
- 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
- GDP / Cold Chain
- GCP / Clinical Quality
- GVP / Pharmacovigilance
- GLP / Nonclinical Laboratory Quality
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.
In active validation
Phase 1 is in design-partner validation. Current workflow and control status is disclosed for each proposed engagement.
First case studies
We will publish customer outcomes and named references only after results exist and the customer provides written approval.
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.
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 to Verixa with clear pilot success criteria.
Validation-Support Materials
Evidence & Validation Pack support — you own intended-use validation.
Inspection-Preparation 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.
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.