v1.4 — Design Specifications (third tier)

Extends the corpus from URS + FS pairs to URS / FS / DS triples. Closes the GAMP 5 V-model authoring chain end-to-end for every system in the corpus.

What's new

• 50 Design Specifications (DS/*_DS_v1.1.md) paired one-to-one with the existing URS + FS by system name. Shape is GAMP-category-driven:
  • Cat 5 (custom-build) → full Software Design Specification (module decomposition, data models, interface contracts, deployment topology)
  • Cat 4 (config-on-COTS) → Configuration Specification (config-vs-code split, vendor-feature inventory, environment-scoped configuration)
  • Cat 3 (instrument) → vendor-design-reliance statement + configuration locks
  • Cat 1 (infrastructure) → Infrastructure Design Specification
• DS-specific methodology + rubric inside the DS/ folder (DS/METHODOLOGY.md, DS/EVAL_RUBRIC.md, DS/CHANGELOG.md) — distinct enough from the URS / FS rules that they warranted a dedicated document rather than a new section in the top-level METHODOLOGY.
• FS → DS traceability matrix in every DS, so the URS → FS → DS chain is end-to-end auditable for Cat 4 / Cat 5 systems.
• README + CITATION.cff updated to reflect three-tier scope. Badges files 100 → 150, lines 42,997 → 79,804.

What's not in v1.4

• URS and FS content unchanged (both stay at file-version v1.3).
• Top-level METHODOLOGY.md (URS / FS rules) and EVAL_RUBRIC.md unchanged.

Download

The attached gxp-corpus-v1.4.zip (2.0 MB) is the same archive served at https://neuralarchitects.ae/gxp-corpus.

License

Creative Commons Attribution-ShareAlike 4.0 International (CC-BY-SA 4.0).

v1.3 — URS structural review

v1.3 — 2026-05-13 (URS structural review — Project Mode + risks-leave-URS)

Released: 2026-05-13 — applies the LLM Council verdict (2026-05-13) on three URS structural concerns raised by Nabil Attia. Targeted v1.3 polish, not a rewrite.

Decisions ratified by LLM Council 2026-05-13

#	Concern	Council verdict	v1.3 action
Q1	Vendor naming in Cat 4 URS § 5 (e.g., Medidata Rave)	(C) Hybrid — vendor naming in scope / vendor-assurance / integrations is legitimate IF the URS is a configuration-on-pre-selected-COTS project; make project mode explicit	New METHODOLOGY § 2A.15 (Project Mode declaration rule) + Project Mode line in every URS Document Control block
Q2	Vendor-named integration sub-sections (Argus, Medidata Coder, Okta, etc.)	(C) Hybrid — URS keeps the business-level integration need + named enterprise systems; protocol/endpoint detail moves to FS	Deferred to a future v1.4 polish (no corpus-wide URS rewrites required in v1.3)
Q3	URS § 9 Top-level Risks	User Option A: remove from URS, move to FS	New METHODOLOGY § 2A.16 (FS Implementation Risk Register rule). URS § 9 removed corpus-wide; content transferred to FS as a new last-numbered-section Implementation Risk Register. URS § 10 References renumbered to § 9.

User-driven rationale for Q3 (recorded for future readers)

"A requirement is a wish. A wish cannot have risks — only an implementation can fail. The risks in URS § 9 (mid-study amendment defects, integration drift, configuration errors, credential compromise, SAE reconciliation drift) are all implementation / configuration / runtime / operational risks. They belong in FS (where the implementation lives) or in the formal Risk Assessment artefact (FMEA / HAZOP). The per-requirement GxP-criticality column (R1/R2/R3) stays on every URS requirement — that's a property of the wish, not of the implementation."

Mechanical migration applied (single Python script — /tmp/v1.3_migrate.py)

• All 50 URS — **Project Mode:** line inserted in Document Control block immediately under the **System Class (GAMP 5, 2nd ed.):** line. Wording derived deterministically from declared GAMP category (Cat 5 → custom-build; Cat 4 → configuration on commercial software; Cat 3 → configuration on non-configurable instrument; Cat 1 → infrastructure qualification).
• All 50 URS — § 9 Top-level Risks section removed entirely. § 10 References renumbered to § 9.
• All 50 FS — new last-numbered-section ## N. Implementation Risk Register appended after the existing URS → FS Traceability Matrix section. Content transferred verbatim from URS § 9 (Risks table) with a new intro paragraph clarifying the implementation-not-wish framing.
• All 50 FS — Revision History (top-of-file) table extended with a v1.3 entry documenting the new section.

METHODOLOGY updates

• § 2A.12 Document-structure invariants — URS now declared to end at § 9 References (was § 10). FS now declared to include an Implementation Risk Register as the final numbered section. Rationale paragraph added explaining the wish-vs-implementation framing.
• § 2A.15 NEW Project Mode declaration rule — canonical wordings per GAMP category. Mandatory in every URS Document Control block.
• § 2A.16 NEW FS § 9 Implementation Risk Register rule — placement, structure (ID | Risk | Likelihood | Impact | Mitigation reference | Implementation surface), separation from the formal RA artefact.

Verification — all gates pass (2026-05-13)

• 50/50 URS have Project Mode line directly under System Class
• 50/50 URS no longer carry § 9 Top-level Risks
• 50/50 URS end at § 9 References → END marker
• 50/50 FS now carry an Implementation Risk Register section as last numbered section
• 50/50 FS preserve END marker
• 100/100 files have valid YAML + do_not_use_as ⊇ {regulated_record} + labelling.source_risk = ai_authored_disclosed
• 0 URS contain Appendix A (preserved from v1.2 decoupling)
• 0 stale-citation hits in actual document content (matches found only in CHANGELOG / METHODOLOGY / README / KNOWN_LIMITATIONS where forbidden patterns are explicitly negated)

Deferred to v1.4 (post-public-release polish)

• Q2 integration-section refactor — strip protocol/endpoint detail from URS § 5.x integration sub-sections; push to paired FS interface specs
• METHODOLOGY § 2A.1 citation-table consolidator pass — merge ~140 new authoritative citations flagged across Waves 1+2+3
• Final independent regression Codex review

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