Navira Quality Systems Implementation
Founder-led deployment and configuration of Verixa in your GMP environment, during design-partner validation. Verixa verifies under its SDLC; the customer validates intended use.
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.
From Discovery to Evaluation
A structured four-phase engagement designed for regulated environments — from first assessment to customer acceptance.
Discovery & Planning
Assess current systems and regulatory context. Develop an implementation roadmap.
Infrastructure & Environment Setup
Deploy infrastructure, configure the GMP module, and define workflows with human-in-the-loop review points.
Configuration & Data Setup
Configure workflows and, where in scope, map data and integrations for evaluation.
Customer Acceptance & Validation Support
UAT support and evaluation acceptance; production planning only where separately approved.
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.
Controls intended to support Part 11
Controls intended to support applicable Part 11 requirements — audit trail, access controls, e-signature workflows; verification happens in design-partner validation; 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.
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.