cff-version: 1.2.0
title: "GAMP 5 Synthetic URS Corpus — Curated First Batch"
message: >-
  If you use this corpus, please cite it as below. The corpus is synthetic,
  AI-authored, and not a regulated record. See README.md and KNOWN_LIMITATIONS.md.
type: dataset
authors:
  - family-names: Attia
    given-names: Nabil
    affiliation: Neural Architects / na IT Consulting GmbH
    email: nat@naitc.de
    orcid: ""
repository-code: "https://github.com/neuralarchitects/gamp5-corpus"
url: "https://neuralarchitects.ae/gamp5-corpus"
abstract: >-
  Fifty synthetic User Requirements Specifications (URS) for GxP-regulated
  computer systems, generated from public regulatory primary sources
  (FDA guidance, ISPE GAMP 5, ICH text, EU GMP Annex 11, EU AI Act 2024/1689)
  and paired with fifty matching Functional Specifications. The corpus covers
  GAMP Categories 1, 3, 4, and 5 across laboratory instruments, production
  control systems, enterprise quality applications, infrastructure, and
  custom-developed AI/ML platforms. Intended as a seed corpus for fine-tuning,
  RAG grounding, and reference templating in regulated industries. Not a
  regulated record; not derived from any client data; not vetted by any
  regulator.
keywords:
  - GAMP 5
  - URS
  - Computer System Validation
  - GxP
  - 21 CFR Part 11
  - EU Annex 11
  - EU AI Act
  - ALCOA+
  - Pharmaceutical Quality
  - Synthetic Dataset
  - LLM Fine-Tuning Corpus
  - Regulated AI
license: CC-BY-SA-4.0
version: "1.0"
date-released: "2026-05-12"
