Navira Quality Systems: The Operating Entity &
Services Arm
Verixa is the platform. Navira Quality Systems is the operating entity, in the US and India, that delivers founder-led quality and advisory services during design-partner validation; product ownership and intellectual-property rights are governed by the applicable agreements. Sense7ai is our implementation partner.
Navira Quality Systems grew out of the founder’s independent GxP consulting practice, established 2016.
One Entity. Platform and Founder-Led Services.
Navira Quality Systems delivers the platform and the services around it; product ownership and intellectual-property rights are governed by the applicable agreements. During the 2026 design-partner validation 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 support for 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 risk-based validation-support templates, RTM and intended-use mapping appropriate to your intended use. Navira supports 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-Preparation Simulation
A founder-led preparation exercise and posture review against your GMP environment, with evidence-pack and response preparation.
Managed Oversight
Evidence-pack refresh, change-notification on model/prompt/retrieval updates, Evidence & Validation Pack re-issue and escalation support — each optional and scoped per engagement. Not a substitute for your QA Authority.
Principles of the Engagement
How we deliver during design-partner validation — founder-led, verify-not-validate, with advisory human-in-the-loop AI.
Founder-led delivery
During design-partner validation, engagements are led by our founder, Vimal Veereshwarayya, PhD, 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 support — 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.
Workflow license
LicenseRecurring license for the selected Verixa workflow or connected workflow pack. 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 design-partner validation.
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 design-partner validation.