Navira Quality Systems Implementation
Founder-led deployment and configuration of Verixa in your GMP environment, with 21 CFR Part 11-aligned controls configured from day one. Verixa is verified under our SDLC; the customer validates intended use.
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.
From Discovery to Go-Live
A structured four-phase engagement designed for regulated environments — from first assessment to production deployment.
Discovery & Planning
Assess current systems and regulatory context. Develop an implementation roadmap.
Configuration & Setup
Deploy infrastructure, configure the GMP module, and define workflows with human-in-the-loop review points.
Data Migration & Integration
Migrate data, establish API connections to existing systems, and validate data integrity.
Environment Readiness & Go-Live
UAT, go-live readiness review, and production deployment.
Built on Regulatory References
Every founder-led implementation is structured around the regulatory references that inform your operating environment — applied as internal-control references, not vendor compliance claims.
21 CFR Part 11-Aligned Controls
Part 11-aligned controls configured from day one — audit trail, access controls, and electronic signature workflows. Verification happens in the design-partner phase; the customer validates intended use.
GAMP 5 as a Reference
GAMP 5 is treated as an internal-control reference. We provide validation-enablement artefacts in parallel with configuration; you own intended-use validation.
ICH Q9 & ICH Q10
Quality risk management and pharmaceutical quality system principles inform workflow design and system configuration choices.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.