This page demonstrates the structure of a ROSIE-compliant product manifest (gxp-product.md). Every repository using ROSIE must contain this file at the root.

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Example Manifest

The gxp-product.md file uses YAML front matter to declare the product’s regulatory context:

---
product_name: "Reference-Implementation-App"
version: "1.0.0"
product_code: "REF"
id_schema: "URS | DS | TC"
sync:
  mode: "repo-first"
  system_of_record: "ROSIE-Compliance-Hub"
---

---

Field Definitions

Field	Type	Description
product_name	string	Human-readable name of the GxP product
version	semver	Current product version
product_code	string	Short code used as prefix for all IDs (e.g., REF-URS-001)
id_schema	string	Defines the hierarchy of traceable artifacts
sync.mode	enum	repo-first or sor-first — determines source of truth
sync.system_of_record	string	Name of the connected SoR system

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Extended Manifest Example

For production systems, the manifest includes additional metadata:

---
product_name: "LabData-Processor-Core"
version: "2.1.0"
product_code: "LDPC"
id_schema: "URS | FRS | DS | TC"
sync:
  mode: "repo-first"
  system_of_record: "Nexus-QMS"
dependencies:
  - repo: "github.com/org/shared-auth"
    id_prefix: "AUTH-"
gxp_metadata:
  gamp_category: 5
  risk_impact: "High"
---

---

Repository Structure

A compliant repository typically follows this structure:

my-gxp-product/
├── gxp-product.md          # Product manifest (required)
├── specs/
│   ├── urs/                # User Requirements
│   │   └── urs-001.md
│   ├── frs/                # Functional Requirements
│   │   └── frs-001.md
│   └── ds/                 # Design Specifications
│       └── ds-001.md
├── src/
│   └── ...                 # Source code with @gxp-id annotations
├── tests/
│   ├── unit/               # OQ tests
│   ├── integration/        # OQ tests
│   └── e2e/                # PQ tests
└── evidence/
    └── gxp-execution.json  # Generated evidence package

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ID Naming Convention

All traceable artifacts follow the pattern:

{PRODUCT_CODE}-{TYPE}-{NUMBER}

Examples:

• REF-URS-001 — User Requirement
• REF-FRS-001 — Functional Requirement
• REF-DS-001 — Design Specification
• REF-OQ-001 — Operational Qualification test
• REF-PQ-001 — Performance Qualification test

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Next Steps

1. Review the Data Standard (RFC-001) for tagging syntax
2. Understand the Engine Spec (RFC-002) for sync behavior
3. Learn about Evidence Packaging (RFC-003) for test outputs