Navira Quality Systems Validation Support
IQ/OQ/PQ protocol templates, RTM, intended-use mapping, and a known-limitations register (G-7 leverage). The customer validates intended use; Navira provides templates, evidence, and consulting that accelerate but do not replace your validation responsibility.
During the design-partner phase, engagements are founder-led by Vimal Veereshwarayya, PhD, RAC, working with a CSV/CSA contractor. During 2026 H2 we run two active design partners at a time.
Protocol Templates in Three Phases
We provide IQ/OQ/PQ protocol templates across three phases for you to execute and own — from installation confirmation through to production-scenario performance evidence.
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 (G-7 leverage) to inform your risk assessment and intended-use validation.
Verification Evidence
SDLC verification evidence and supporting test artefacts, structured for regulator 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.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.