Navira Quality Systems: The Operating Entity &
Services Arm
Verixa is the platform. Navira Quality Systems (Pvt Ltd) is the operating entity, in the US and India, that owns the Verixa platform IP and delivers founder-led quality and compliance services during the design-partner phase. Sense7ai is our implementation partner.
One Entity. Platform and Founder-Led Services.
Navira Quality Systems owns the Verixa platform IP and delivers the services around it. During the 2026 design-partner phase we work with two active design partners at a time.
You want founder-led implementation, validation enablement, and a Phase 1 GMP gap assessment.
You want to accelerate your own validation under a verify-not-validate engagement.
You want quarterly managed oversight, inspection escalation support, and advisory human-in-the-loop review.
Platform + Founder-Led Assurance
Every service is designed to integrate with Verixa — so founder-led work and platform data stay connected.
Implementation & Validation Enablement
Founder-led deployment and configuration, plus IQ/OQ/PQ protocol templates, RTM, and intended-use mapping. Navira accelerates your validation; you own intended-use validation.
Phase 1 GMP Gap Assessment
GMP audit-trail gaps, MIRA human-in-the-loop gap analysis, Annex 22 (Draft 2025) internal-control readiness, and CSV/CSA-aligned remediation plans.
Inspection-Readiness Simulation
A founder-led readiness exercise and posture review against your GMP environment, with evidence-pack and response preparation.
Managed Oversight
Quarterly evidence-pack refresh, change-notification on model/prompt/retrieval updates, annual G-7 re-issue, and inspection escalation support. Not a substitute for your QA Authority.
Principles of the Engagement
How we deliver during the design-partner phase — founder-led, verify-not-validate, with advisory human-in-the-loop AI.
Founder-led delivery
During the design-partner phase, engagements are led by our founder, Vimal Veereshwarayya, PhD, RAC, working with a CSV/CSA contractor.
Verify, not validate
Verixa is verified under our SDLC; the customer validates intended use. Navira provides templates, evidence, and consulting that accelerate — but do not replace — your validation responsibility.
Advisory AI, human-in-the-loop
MIRA is advisory and human-in-the-loop. It supports reviewers and never makes GxP-critical decisions autonomously.
How Engagements Are Structured
A modular structure — start with Phase 1 GMP and the founder-led engagement, then expand along the roadmap.
Platform license
PlatformRecurring license for the Verixa platform. Phase 1 begins with GMP; Supplier Quality (Phase 2) and GCP/GVP/GDP (Phase 3, 2028+) follow the roadmap.
Founder-led services
EngagementDeployment, configuration, and validation-enablement consulting delivered founder-led during the design-partner phase.
Managed Oversight
Optional RetainerOptional quarterly oversight: evidence-pack refresh, change-notification, and inspection escalation support.
Founder-Led Quality, Built Around Verixa
Talk to the Navira Quality Systems team about founder-led implementation, validation enablement, gap assessment, or managed oversight during the design-partner phase.