Navira Quality Systems Validation Support
IQ/OQ/PQ protocol templates, RTM, intended-use mapping, and a known-limitations register (Evidence & Validation Pack leverage). The customer validates intended use; Navira provides templates, evidence, and consulting that accelerate but do not replace your validation responsibility.
During design-partner validation, engagements are founder-led by Vimal Veereshwarayya, PhD, working with a CSV/CSA contractor. During 2026 H2 we run two active design partners at a time.
Risk-based validation-support templates
We provide risk-based protocol templates — which may include IQ/OQ/PQ where appropriate to your intended use — for you to execute and own. The approach follows your quality system and risk assessment, not a fixed template set.
Installation Qualification
Verify components correctly installed and configured.
- Component install & environment configuration verified
- Configuration baseline captured
- Access controls & user roles confirmed
Operational Qualification
Demonstrate consistent operation across normal and edge-case scenarios.
- Functional test cases across normal & edge scenarios
- MIRA advisory + HITL gate behaviour exercised
- Audit-trail & e-signature capture verified
Performance Qualification
Demonstrate accurate execution of critical quality workflows.
- Critical GMP workflows under production-like conditions
- End-to-end evidence generation confirmed
- Intended-use mapping — the customer validates intended use
Your Validation-Enablement Package
Six artefacts that accelerate your validation — templates, traceability, and evidence you execute and own. Navira does not replace your validation responsibility.
IQ/OQ/PQ Protocol Templates
Authored IQ, OQ, and PQ protocol templates with defined test cases, acceptance criteria, and sign-off workflow for you to execute and own.
Requirements Traceability Matrix (RTM)
End-to-end traceability from user requirements through design specifications to test evidence.
Intended-Use Mapping
A structured mapping of your intended use to system functions — the basis on which the customer validates intended use.
Known-Limitations Register
A documented register of known limitations to inform your risk assessment and intended-use validation.
Verification Evidence
SDLC verification evidence and supporting test artefacts, structured for customer QA review.
Validation Enablement Summary
A summary of the enablement artefacts provided and open items. Navira accelerates your validation; you own the intended-use validation conclusion.
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.