# GAMP 5 Synthetic URS+FS Corpus — v1.3

50 User Requirements Specifications (URS) + 50 paired Functional Specifications (FS),
covering the regulated pharma / biotech / medical-device system landscape — small
Cat-3 instruments, configured Cat-4 lab platforms, Cat-5 custom AI/ML platforms,
enterprise quality systems (LIMS, EDMS, eQMS), clinical-trial systems (EDC, CTMS,
eTMF, RIM, ePRO, LMS, Submissions), post-market systems (PV, EU MDR PMS, AE DB,
cold chain), and shared IT infrastructure (Active Directory, Backup).

- **Authored by:** Nabil Attia (Neural Architects / NA IT Consulting, Sandhausen, Germany)
- **License:** CC-BY-SA 4.0 (see `URS/CITATION.cff` for citation metadata)
- **Total:** 100 documents, ~42,997 lines of Markdown
- **Methodology, evaluation rubric, changelog, and known limitations:** included alongside
  the URS and FS folders.

## ⚠ Not a regulated record

Every file in this corpus carries `do_not_use_as: regulated_record` and
`labelling.source_risk: ai_authored_disclosed` in its YAML frontmatter. Companies,
dates, and identifiers are marked `*(synthetic)*`. No FDA, EMA, BfArM, Swissmedic,
or other competent authority has reviewed or signed off on this material.

If you derive an operational artefact from it, your Quality Unit MUST review, edit,
sign, and approve it under your own change-control before it has any regulated
status.

## What's inside

```
gxp-corpus-v1.2/
├── README.md                            (this file)
├── URS/
│   ├── METHODOLOGY.md                   canonical rule-set
│   ├── EVAL_RUBRIC.md                   grading rubric for derived URS
│   ├── CHANGELOG.md                     v1.0 → v1.1 → v1.1.1 → v1.2 → v1.3
│   ├── KNOWN_LIMITATIONS.md             honest limits
│   ├── CITATION.cff                     CC-BY-SA 4.0 citation metadata
│   └── 50× *_URS_v1.3.md
└── FS_FDS/
    ├── METHODOLOGY.md                   mirrored
    ├── EVAL_RUBRIC.md                   mirrored
    ├── CHANGELOG.md                     mirrored
    ├── KNOWN_LIMITATIONS.md             mirrored
    └── 50× *_FS_v1.3.md
```

## How to cite

See `URS/CITATION.cff`. Short form:

> Attia, N. *GAMP 5 Synthetic URS+FS Corpus*, v1.3 (2026). NA IT Consulting
> (Neural Architects), Sandhausen, Germany. Licensed CC-BY-SA 4.0.

## Hub page

<https://neuralarchitects.ae/gxp-corpus>
