# GAMP 5 Synthetic URS Corpus — Curated First Batch (50 docs)

**Status:** synthetic, AI-authored, disclosed.
**License:** CC-BY-SA 4.0.
**Companion folder:** [`FS_FDS/_generated/final/`](../../FS_FDS/_generated/final/) — 50 matching Functional Specifications paired to these URS by system.

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## What this is

50 User Requirements Specifications for regulated computer systems used in pharmaceutical, biotech, and medical-device manufacturing, QC laboratories, and clinical operations. The corpus is generated from regulatory primary sources (FDA guidance, ISPE GAMP 5, ICH text, ISO 13485, EU GMP Annex 11, EU AI Act) and is structured for use as:

- **A reference template** for teams writing new URS in GxP-regulated environments
- **A seed corpus** for fine-tuning or RAG-grounding AI tooling against regulated-industry validation patterns
- **A teaching artefact** for validation engineers, QA managers, and computer system validation (CSV) practitioners learning the GAMP 5 conventions

## What this is NOT

- **Not a regulated record.** These documents must never be used as the basis for a real validation decision, audit response, or submission. They are synthetic.
- **Not anonymized customer data.** No URS in this corpus is derived from any client engagement at Roche, Lonza, Merck KGaA, Bayer, Boehringer Ingelheim, or any other party. The corpus was generated from regulatory primary sources only.
- **Not vetted by a regulator.** No FDA, EMA, BfArM, Swissmedic, or other competent authority has reviewed these documents.
- **Not a substitute for real validation work.** Producing a real URS requires a process owner, a system owner, signed change control, and a Quality Unit's review and approval.

## Coverage (50 systems)

GAMP categories represented:

- **Category 1 (Infrastructure):** Active Directory, Backup, NTP, Patch Management, ZTNA Gateway, Credential Vault (Cat 1 in this corpus subset)
- **Category 3 (Non-Configurable COTS):** Lab instruments, simple data loggers
- **Category 4 (Configured Products):** LC-MS, HPLC, ICP-MS, GC-MS, UV-Vis, NIR, Karl Fischer, dissolution apparatus, TOC analyzer, autoclave, lyophilizer, tablet coater, bioreactor SCADA, DCS, MES, LIMS, ELN, EDMS, eQMS, CTMS, eTMF, RIM, LMS, CMMS, EDC, ePRO, SPC, Continuous Manufacturing, Pharmacovigilance, RTRT, Stability, EU MDR PMS, Veeva Vault Submissions, Cold Chain Logger, Process Historian
- **Category 5 (Custom / Site-Developed):** AI/ML Inference Platform (FastAPI + K8s + MLflow + Seldon Core), Validated GenAI LLM-as-a-Service, Custom Audit-Trail Review Workbench, Custom Computer Vision Inspection, Custom-coded compendial calculator

Regulatory frameworks anchored:

- **US:** 21 CFR Part 11 (Electronic Records / Signatures), 21 CFR Part 211 (CGMP), FDA Computer Software Assurance (CSA, February 2026 final; supersedes September 2025), FDA AI/ML-Based SaMD Action Plan (2021), FDA Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025)
- **EU:** EU GMP Annex 11 (Computerised Systems), draft Annex 22 (Artificial Intelligence), EU MDR 2017/745, EU IVDR 2017/746, EU AI Act 2024/1689 (high-risk AI deadline 2026-08-02), EudraLex Vol 4, EudraVigilance
- **DACH-specific:** BfArM (DE), Swissmedic (CH), AGES (AT), Anlage 7 GMP-Inspektion
- **ICH:** Q2(R2), Q3A, Q3B, Q9, Q10, Q14
- **ISPE:** GAMP 5 (2nd Edition, 2022), GAMP GPG *AI/ML in GxP*, GAMP RDI
- **Data Integrity:** ALCOA+, PIC/S PI 041, MHRA Data Integrity Guidance

## How each URS is structured

Every URS in this batch follows the GAMP-aligned canonical skeleton:

1. **Document Control** — author / reviewer / approver placeholders, revision history
2. **Definitions and Acronyms**
3. **§1 Purpose**
4. **§2 Scope** — in-scope, out-of-scope, system-boundary diagram
5. **§3 System Description and Intended Use** — with GAMP category labeled
6. **§4 User Roles** — table with permissions and separation-of-duties enforcement
7. **§5 User Requirements** — broken into 8–12 subsections (Hardware/Software/Functional/Audit Trail/21 CFR Part 11/ALCOA+/Backup/Performance/Security/Training/Periodic Review). Every requirement carries a unique ID, a priority (H/M/L), a GAMP-5 risk class (R1/R2/R3), and a verifiable `shall`-clause.
8. **§6 Acceptance Criteria** — gates the system into validated routine GMP use
9. **§7 Constraints** + **§8 Assumptions** + **§9 Top-level Risks**
10. **§10 References** — regulatory primary sources
11. **Appendix A — Traceability Seed** — URS-ID → planned FS-ID → planned IQ/OQ/PQ test ID

## Each URS pairs to an FS

For every URS in this folder, a Functional Specification exists in [`FS_FDS/_generated/final/`](../../FS_FDS/_generated/final/) addressing each URS-line with a corresponding FS-line. The pairing is the seed for a downstream Requirements Traceability Matrix (RTM).

## Known limitations

See [`KNOWN_LIMITATIONS.md`](KNOWN_LIMITATIONS.md) for a documented list of what this corpus does well, what it does less well, and what we'd improve in the next batch.

## How to cite

If you use this corpus in a paper, blog post, fine-tune, or open dataset, please cite:

```
Attia, N. (2026). GAMP 5 Synthetic URS Corpus — Curated First Batch (50 docs).
Neural Architects. Released under CC-BY-SA 4.0.
https://neuralarchitects.ae/gamp5-corpus
```

A machine-readable `CITATION.cff` is included in this folder.

## Provenance and disclosure

Each document carries inline YAML frontmatter with:

- `artifact_class: synthetic_csv_corpus_seed`
- `artifact_status: GENERATED`
- `generator: Claude (Anthropic) — variant-synthesis test, 2026-04-26`
- `seed_corpus_basis:` — the public-domain regulatory references the generator drew on
- `do_not_use_as: [regulated_record, basis_for_real_validation_decisions]`
- `intended_use: [LLM fine-tuning corpus seed, prompt-tuning evaluation]`
- `labelling.evidence_level: synthetic_seeded`
- `labelling.signature_status: placeholders`
- `labelling.production_status: simulated_or_example`
- `labelling.source_risk: ai_authored_disclosed`

Dates, site names, document numbers, and personnel placeholders are marked `*(synthetic)*` inline.

---

**Contact:** Nabil Attia · Neural Architects · [neuralarchitects.ae](https://neuralarchitects.ae/) · nat@naitc.de

*This release is part of a 30-day campaign to publish the missing primary resource for regulated AI tooling. Day 0 ships URS + FS. Subsequent waves expand to Risk Assessment, Validation Plan, Test Plan, and a Qwen 3 7B model fine-tuned on the corpus.*
