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

**Status:** synthetic, AI-authored, disclosed.
**License:** CC-BY-SA 4.0.
**Companion folder:** [`URS/_generated/final/`](../../URS/_generated/final/) — 50 paired User Requirements Specifications.

---

## What this is

50 Functional Specifications (FS) for regulated computer systems, each addressing the URS-line-by-line in the matching URS document. The FS is the next document down the V-model from the URS — it describes *how* the system implements each user requirement, where the URS describes *what* the user requires.

Every FS in this batch carries:

- **Cross-reference to the URS** in document control
- **Section structure** mirroring the URS: §1 Purpose, §2 Scope, §3 System Description, §4 User Roles, §5 Functional Specifications (broken out by domain), §6 Acceptance, §7 References, §8 Traceability
- **Per-line traceability** — every FS line carries an `FS-ID` mapped to its source `URS-ID`
- **Implementation detail** — vendor product, version, configuration parameter, code path, integration endpoint — where the URS abstracted, the FS concretizes
- **Test reference** — each FS line cites the planned IQ / OQ / PQ test that verifies it

## How URS and FS pair

```
URS (this is what the user requires)         FS (this is how we implement it)
─────────────────────────────────────        ─────────────────────────────────────
URS-PART11-04: The system shall enforce      FS-PART11-04 (URS-PART11-04):
  separation of duties: a user with the        MassLynx user profile "Analyst" has
  Analyst role shall not be able to apply      `CanApproveResults = False` in the
  a Reviewer or Approver signature on the      User Profile table; the Approve
  same record.                                 button is hidden via the profile
                                               role-binding rule. Verified by
                                               OQ-PART11-04.
```

The pairing is the seed for a downstream Requirements Traceability Matrix (RTM).

## Folder layout

```
FS_FDS/_generated/final/
├── README.md                   ← this file
├── KNOWN_LIMITATIONS.md        ← limitations of the corpus
├── CITATION.cff                ← citation metadata
└── <Company>_<System>_FS_v1.0.md  × 50
```

## Disclaimer (same as URS corpus)

- **Not a regulated record.** These documents must never be used as the basis for a real validation decision, audit response, or submission.
- **Not anonymized customer data.** Generated from regulatory primary sources only.
- **Not vetted by any regulator.**

See the URS folder's [`README.md`](../../URS/_generated/final/README.md) for the full disclosure block, coverage summary, and known limitations. The disclosure applies identically to this FS corpus.

## How to cite

```
Attia, N. (2026). GAMP 5 Synthetic URS+FS 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.

---

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