# Verixa · Messaging & Claim-Discipline Guardrails (for Marketing)

**Version:** 2026-06-24 · **Owner:** Vimal Veereshwarayya, Founder · **Status:** Locked — governs ALL Verixa content

> Verixa sells into pharma/biotech GxP quality — a regulated market. Claims are scrutinised. A single over-claim ("validated," "compliant," "audit-ready") can destroy buyer trust and create regulatory exposure. This document is not a style preference; it is a compliance control. Follow it exactly.

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## 1. Positioning

**One-liner:** Governed, AI-native, tamper-evident — and honest about validation.

**What Verixa is:** an AI-native GxP quality management system (eQMS) for pharma & biotech, built governance-first to the AI rules the industry is moving toward (EU Annex 22 draft, EU AI Act).

**The wedge (what we lead with):** a governed, human-reviewed **AI evidence workflow** for the GMP **deviation → risk → RCA → CAPA → audit-preparation** chain — proven on one bounded workflow, one facility, in 90 days.

**Who it's for:** emerging / clinical-stage biotech, ATMP / cell-and-gene, and small specialty CDMOs with real GxP burden and **no mature eQMS** in place (India, Lane A).

**Why it's different:** incumbents bolted AI onto pre-AI systems. Verixa is AI-native, with a tamper-evident (hash-chained) audit trail and human-in-the-loop control — and we are precise about what is and isn't done, rather than over-claiming.

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## 2. APPROVED language (use these)

- validation-ready · in customer-validation phase
- implemented · internally tested · technically verified against defined test cases
- validation documentation in progress · formal customer validation pending · independent QA review pending
- governed AI · AI-native · human-in-the-loop · human-reviewed
- tamper-evident, hash-chained audit trail
- Part 11-oriented e-signature controls · inspection-preparation evidence · bounded Phase-1 evidence workflow
- **design partner** (this is how we refer to early customers)
- "subject to customer validation before production use" (use as the standard caveat)

## 3. BANNED language (never use — especially in public/buyer-facing assets)

| ❌ Never write | ✅ Use instead |
|---|---|
| validated · validated AI eQMS | validation-ready · in customer-validation phase |
| compliant · Part 11 / Annex 11 compliant | Part 11-oriented controls · built toward Part 11 / Annex 11 expectations |
| audit-ready · audit-readiness | audit-preparation evidence |
| inspection-ready · inspection-readiness | inspection-preparation evidence |
| GxP-ready · regulator-safe | governed for GxP use · architected to GxP expectations |
| independently verified · QA-verified | internally tested · independent QA review pending |
| full-suite QMS replacement | governed AI evidence workflow (expandable across the QMS) |
| pilot customer · founding customer · launch partner · beta partner · early adopter · validated/compliance/audit-ready partner | **design partner** |
| "we saw your 483" / referencing a specific company's findings | speak to the general GMP evidence burden, never a named finding |
| platform · copilot (avoid in buyer-facing copy per locked lexicon) | Verixa · the system · AI assistant / AI evidence workflow |

**Rule of thumb:** if a word implies a regulatory state we have not achieved (validated, compliant, ready for an inspection), it is banned. We describe what is *built and internally tested*, and we always note the customer owns validation.

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## 4. Ready-to-use boilerplate (pre-approved — copy these)

**Short (1 line):**
> Verixa is an AI-native GxP quality system that turns GMP deviation, RCA, and CAPA work into governed, audit-preparation-grade evidence — with human-in-the-loop control and a tamper-evident audit trail.

**Standard (50 words):**
> Verixa is an AI-native quality management system for pharma and biotech GMP teams. It runs the deviation → risk → RCA → CAPA → audit-preparation workflow as a governed, human-reviewed AI evidence chain, with a tamper-evident audit trail and Part 11-oriented e-signature controls. Built validation-ready; customers own validation before production use.

**Boilerplate (about / footer):**
> Verixa is an AI-native GxP quality management system built governance-first for pharma and biotech. Verixa is a product of Navira Quality Systems Pvt Ltd. Verixa is validation-ready and in its customer-validation phase; customer validation is required before production use.

**Mandatory caveat — append to any external asset that describes capability:**
> *Verixa is validation-ready and in customer-validation phase. Customer validation is required before production use. Verixa does not claim to be validated, compliant, audit-ready, inspection-ready, or GxP-ready.*

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## 5. Audience & tone

- **Audience:** GMP QA leaders, QMS / validation directors, quality heads at emerging biotech / ATMP / CGT / specialty CDMOs (India, Lane A). Technically sophisticated, sceptical of vendor over-claim, inspection-aware.
- **Tone:** precise, credible, operator-to-operator. Built by a 20+ year pharma QA/RAC founder. Confident but never hyped. Honesty is a feature, not a weakness — it is our differentiator.
- See `03_Audience_ICP/` for the detailed ICP segments.

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## 6. Content do's & don'ts

**Do**
- Lead with the GMP evidence-burden pain and the governed AI workflow that addresses it.
- Use the approved boilerplate and the design-partner framing.
- Keep the founder's operator credibility central (20+ yrs pharma & biotech; 16+ yrs QA & Regulatory).
- Run every external claim against the banned list before publishing.

**Don't**
- Don't publish pricing. The Phase 0 / Phase 1 numbers exist for sales conversations after a fit call — never in ads, website, or social. (Pricing is intentionally not in this package's public-use scope.)
- Don't publish competitor comparisons or name competitors externally. The competitive material here is internal context for sharpening *our* differentiation only.
- Don't name or imply specific prospects, customers, or their inspection findings.
- Don't describe Verixa as a "platform," "copilot," "pilot," or "validated/compliant" anything.
- Don't invent metrics or outcomes. We measure results during a design-partner sprint; we don't promise guaranteed savings.

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## 7. Approval

All external-facing Verixa copy and creative is **approved by the founder before publication**. This is a regulated-market claim-control requirement, not a bottleneck preference.

**Approver:** Vimal Veereshwarayya, PhD, RAC · `vimalv@verixa.ai`
