AI-powered quality and compliance for manufacturing, clinical, pharmacovigilance, laboratory, and distribution teams. Every AI recommendation passes through a human decision gate. Every action audit-trailed.
| ID | SEVERITY | STATUS |
|---|---|---|
| DEV-2024-001 | Critical | In Review |
| DEV-2024-002 | High | CAPA Active |
| DEV-2024-003 | Medium | Closed |
Manual processes drain your team.
Unpredictable consulting spend.
Findings that don't hold up under inspection.
Universal GxP Core with domain-specific activation.
Severity classification, root cause, and closure workflows
Corrective/preventive action tracking with effectiveness checks
5×5 RPN scoring and risk prioritization
6 methods + AI-assisted hypothesis generation
4-tier library with version control and regulatory traceability
Role-based learning paths and competency tracking
Hash-chain protected, 15+ fields, immutable
SLA enforcement and escalation rules
Real-time KPIs and regulatory-grade export
One click activates domain-specific fields, workflows, roles, and AI context. Switch from GMP to GCP in seconds.
Four core AI capabilities, each with a human decision gate.
Natural language queries with contextual assistance. Ask questions about deviations, CAPAs, and compliance — get instant answers with audit trail.
Automated quality assessment for deviations and investigations. Passes through human QA gate before finalization.
RAG-based retrieval of your regulatory documents, SOPs, and prior FDA responses. Citations always transparent.
Analytics, training gap detection, and trend forecasting. AI identifies patterns; humans decide actions.
HITL governance is non-negotiable for FDA and EMA.
AI Suggests
System generates recommendation
Human Reviews
SME validates and decides
Decision Logged
Action finalized by human
Audit Trail
Both AI and human logged
Deviation Classification
AI classifies deviation severity → QA Manager reviews and confirms
CAPA Recommendation
MIRA recommends corrective action → Quality Lead approves or modifies
Risk Scoring
Risk score calculated by RPN → Human acknowledges and adjusts
Anomaly Detection
Anomaly flagged in data → Investigator confirms or dismisses
Universal platform with domain-specific depth.
When an inspector asks "show me all deviations across your organization" — it's one query across GMP, GCP, GVP, GLP, and GDP. One audit trail. One source of truth.
Electronic records and signatures for FDA compliance
Computer systems validation and data integrity
Pharmaceutical quality systems framework
Guidance for validation of computerized systems
Good Clinical Practice for trials
Good Pharmacovigilance Practice
Deploy on your AWS, Azure, or GCP account. You own the infrastructure.
You provide and pay for your own OpenAI, Anthropic, or Cohere API keys. Zero data sharing.
No Verixa cloud. No data escrow. Your data stays in your infrastructure.
JWT authentication, 2FA, IP whitelisting, hash-chain integrity verification.
Deploy Verixa on your AWS/Azure/GCP account. Configure domain-specific workflows, roles, and integrations. Handoff-ready in 2-3 weeks.
GAMP 5-compliant installation, operational, and performance validation. Full CSV documentation package included.
Role-based, scenario-driven training for QA, operations, regulatory, and compliance teams. Train-the-trainer model available.
Navira QA runs alongside your team during the maturity period. As proficiency grows, we transition to advisory-only support.
Even if you don't use Verixa, these GxP services are available to all organizations.
Independent GxP audit for QA teams that need qualified bandwidth. Any domain. 7-10 business days.
Deliverables:
30-day intensive pre-inspection gap assessment, remediation, and evidence packaging for FDA, EMA, or MHRA.
Deliverables:
Structured CAPA resolution — clears QA's backlog and fixes root cause. Breaks the cycle. 15-20 business days.
Deliverables:
Scope & Tier
Fixed SOW locked Day 1
Evidence Intake
Structured via Verixa platform
Execution
AI-assisted with SME validation
QA Gate
Hash-chain verification
Delivery
7–10 days
Navira QA maintains an on-demand network of qualified GxP professionals. Every audit finding, CAPA recommendation, and readiness assessment is reviewed and signed off by a domain expert.
"Your next inspection is coming. Your current system isn't ready. Verixa gives you visibility, speed, and proof."
"Quality failures cost 10–100x the prevention. A single FDA warning letter: $5M–$50M. Verixa costs a fraction."
"Every sponsor audit is a contract renewal test. Verixa proves you're audit-ready. Every time."
"A consent decree costs $5M–$50M+ and destroys shareholder value. Verixa is insurance that works."
| Capability | Verixa | Veeva Vault | TrackWise | Qualio |
|---|---|---|---|---|
| Cloud-Native Architecture | ✓ | ✓ | ✗ | ✓ |
| Modern, Responsive UI | ✓ | ✓ | ✗ | ✓ |
| 21 CFR Part 11 E-Signatures | ✓ | ✓ | ✓ | ✗ |
| Multi-Domain GxP (5+ domains) | ✓ | ✗ | ✓ | ✗ |
| GxP Context Switching | ✓ | ✗ | ✗ | ✗ |
| AI-Assisted Quality (HITL) | ✓ | ✗ | ✗ | ✓ |
| Hash-Chain Audit Trail | ✓ | ✗ | ✗ | ✗ |
| Self-Hosted / Customer Cloud | ✓ | ✗ | ✓ | ✗ |
| Composable Pricing (by domain) | ✓ | ✗ | ✗ | ✗ |
Multi-agent AI deliberation for quality decisions is in our specification roadmap. Until it ships, we won't put it on the website.
Signal detection and trend forecasting are planned capabilities. We'll claim them when they're production-ready.
We don't publish ROI statistics without customer data to support them. When our first customers share results, we'll publish them with permission.
Every claim on this website maps to a shipping capability. If it's not here, it's not built yet.
Verixa is an AI-powered GxP quality and compliance platform for pharmaceutical and life sciences organizations. It covers all major GxP domains (GMP, GCP, GVP, GLP, GDP) through a universal core with domain-specific packs. Every AI recommendation passes through a human-in-the-loop decision gate with 21 CFR Part 11 compliant audit trails.
Verixa enforces Human-in-the-Loop (HITL) governance for every AI output. AI classifies — humans confirm. AI recommends — humans approve. AI scores — humans acknowledge. AI flags — humans confirm or dismiss. Both the AI suggestion and the human decision are captured in an immutable, hash-chain audit trail. This is non-negotiable for FDA and EMA compliance.
Verixa is self-hosted on your organization's own cloud infrastructure (AWS, Azure, or GCP). Your data never leaves your environment. You pay your own LLM API provider directly. Full data sovereignty — designed for regulated environments where data residency is non-negotiable.
Verixa covers seven GxP domains through its universal core plus domain packs: GMP (manufacturing), GCP (clinical operations), GVP (pharmacovigilance), GLP (laboratory), GDP (distribution), Biometrics (data management and biostatistics), and Medical Affairs. A GxP Context Selector activates domain-specific fields, workflows, roles, and AI context.
Navira QA is Verixa's quality services team. They handle platform deployment, GAMP 5 validation (IQ/OQ/PQ), team training, and managed QMS oversight during the maturity period. Navira QA also offers standalone GxP compliance services: audits from $4,500, inspection readiness sprints, and CAPA resolution.
Verixa uses composable pricing: Platform Base + GxP Domain Packs (pay only for the domains you operate in) + MIRA AI Tiers. A GMP-only manufacturer pays less than a multi-domain pharma company. Contact us for a customized quote.
20+ years in clinical quality assurance across GCP, GLP, GMP, pharmacovigilance, and computerized systems validation. PhD in Biochemical Pharmacology. Regulatory Affairs Certified (RAC). Before founding Verixa, Vimal led quality assurance programs at Genentech (7 years), Myokardia/BMS, Arcellx, and Alumis — spanning Phase I through Phase III clinical trials, biologics manufacturing, and cell therapy quality systems. Published researcher with work in the Journal of Biological Chemistry and Circulation.
Co-Founder. Previously Head of Engineering at Diana Health and CTO at Zita. MS from NIT Trichy. Leads all platform architecture and evidence chain design.
Owns the Verixa product roadmap. Deep expertise in GxP workflows and regulatory intelligence. Directly engages with early customers.
Leads platform engineering — evidence chain architecture, hash-chain audit trails, deployment automation. 12+ years in biotech infrastructure.
Regulatory methodology across all GxP domains. 18+ years in pharma quality assurance and FDA/EMA inspections.
Quality gate for every Verixa release. Ensures compliance testing and 21 CFR Part 11 validation at every build.
Delivery operations and engagement management. Ensures every Navira QA service engagement runs on time and exceeds scope.
Kalyanaraman Gopalakrishnan — 29 years enterprise technology. Strategic Business Unit Head at Exavalu. Industry veteran guiding Verixa's go-to-market and platform strategy.
Request a personalized demo or scope your Navira QA service engagement.
Regulatory intelligence for quality and compliance leaders.
See Verixa in action. Our product team will walk you through the platform, answer your GxP questions, and show how HITL governance works in practice.
Work with Navira QA for GxP compliance audits, inspection readiness, or end-to-end CAPA execution. Fixed SOW, transparent pricing.
contact@verixa.ai
Last updated: March 2026
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Last updated: March 2026
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