# Verixa · GMP Design Partner Sprint · One-Pager

**90 days to measure whether Verixa reduces GMP deviation-to-CAPA evidence burden, reviewer rework, and audit-preparation friction.**

One facility.  One bounded GMP workflow.  Configured evidence workflow, validation-support package, and baseline-to-outcome ROI readout.

---

## The problem

GMP quality teams don't lack forms.  They lose time reconstructing defensible evidence across deviation, RCA, CAPA, and audit preparation.  The cost is not just time.  It is rework, delayed closure, weak RCA-to-CAPA linkage, and audit-prep scramble.

---

## The sprint

| Element | What |
|---|---|
| **Scope** | One facility · one bounded GMP deviation-to-CAPA evidence workflow |
| **Duration** | 90 days · Baseline (Days 0–15) → Run (Days 15–60) → Outcome (Days 60–80) → Decision (Days 80–90) |
| **What you receive** | Configured workflow · governed evidence pack · measured ROI readout · validation-support package · open gaps log |
| **Customer commitment** | 1 Head of Quality / VP Quality (~3–5 hrs/wk) · 1 SME (~5–8 hrs/wk Days 15–60) · partner-approved historical / redacted / sample / controlled cases · QA reviewer time Days 60–80 |
| **Day-90 decision** | Convert · extend · pause · stop.  Production go-live is NOT a success criterion. |

---

## Phase 1 scope

**Included:**
- GMP deviation intake · risk assessment support · RCA structuring · CAPA evidence pack · human review gates · audit-preparation evidence · traceable AI rationale.

**Excluded:**
- Full eQMS replacement · autonomous GxP decisions · batch release / disposition · OOS disposition automation · validated system-of-record claim · broad GCP / GLP / GDP / GVP rollout · customer-validated production go-live in Phase 1.

---

## Commercial offer

| Option | Duration | Price | Includes |
|---|---|---|---|
| **Option 1 · Evidence Mapping Sprint** | 10 business days | **₹3 lakh** | Workflow scoping memo · sample evidence pack template · architecture fit assessment · Phase 1 SoW draft.  **100% credited to Phase 1 if you convert within 30 days.**  No forced conversion. |
| **Option 2 · GMP Design Partner Sprint (recommended)** | 90 days | **₹9 lakh** | One facility · one bounded GMP deviation-to-CAPA workflow · configured workflow · governed evidence pack · ROI readout · validation-support pack · gap log · 12-month controlled evaluation access (subject to customer validation before production use) · acceptance criteria written into SoW. |

**Founding Design Partner pricing — first 2 partners only.**  These rates are reserved for the first two design partners who sign by **31 December 2026**.  Subsequent cohorts move to standard pricing.

**This is not a demo fee.**  It funds workflow configuration, baseline measurement, governed evidence-pack production, validation-support documentation, ROI readout, and founder-led adaptation for one GMP workflow.

---

## Responsibility boundary

| Verixa provides | Customer owns |
|---|---|
| Implemented workflow controls | Intended use |
| Validation-support documentation | Validation execution |
| AI governance evidence | QA approval |
| Traceable workflow output | SOP approval |
| Technical support during sprint | Training records |
| Founder-led configuration guidance | Production release decision |

**Verixa does not claim "validated," "compliant," "audit-ready," "inspection-ready," "GxP-ready," or "regulator-safe."**  Customer validation is required before production use.

---

## Measured decision · not guaranteed savings

The sprint measures **time** (deviation triage · RCA drafting · CAPA evidence-pack prep · audit-prep retrieval), **rework** (reviewer cycles · investigation handoff loops), **evidence gaps** (per case · RCA→CAPA linkage · risk-rationale completeness), and **reviewer acceptance** (QA accept rate · inspection-prep readiness · documentation completeness).

Day-90 decision rule: **convert only if measured burden reduction, evidence-quality improvement, and workflow fit justify Year-1 evaluation.**

The sprint pays for a measured decision, not a demo.  Illustrative economics only · partner baseline required · savings are measured during the sprint, not assumed.

---

## Founder

**Vimal Veereshwarayya, PhD, RAC** · Founder · Verixa
20+ years pharma & biotech · 16+ years QA and Regulatory.
Built by someone who has lived GMP deviation, CAPA, inspection, CSV/CSA, and data-integrity pressure.

---

## Next step

**20-minute workflow-fit call.**  One question we answer together:

> "Do you have a GMP deviation, RCA, CAPA, or audit-prep workflow where evidence assembly or QA reviewer rework is consuming measurable time?"

If yes → Phase 0 Evidence Mapping Sprint.  If no → stop.

**Vimal Veereshwarayya, PhD, RAC** · Founder · Verixa
`vimalv@verixa.ai` · Navira Quality Systems Pvt Ltd · 23 June 2026

*Confidential — for prospective Design Partners.  Implemented codebase.  Validation package in progress.  Customer validation required before production use.*
