aw-spec-cli 0.1.8 → 0.1.9

package/assets/docs/pharma-constitution.my-ref.md

@@ -1,86 +0,0 @@
-# Pharma Constitution — Domain Addenda
-
-> **Domain addenda to the technology constitution.** Not ratified on its own — compose it with
-> the technology base.
-
-## How to use (compose-at-ratification)
-
-The technology base (`docs/technology-constitution.md`) **auto-loads** for `/aw-spec-constitution`,
-so you pass only this domain addenda:
-
-```
-/aw-spec-constitution @docs/pharma-constitution.md
-```
-
-This file supplies **only** the pharma deltas: project identity, regulatory posture, the pharma
-domain principles (which **continue** the technology numbering at **XVI**), folder additions,
-governance overrides, and the active-domain pointer. The reusable principles I–XV live in the
-technology base and are not repeated here.
-
-Active domain folder: `docs/domainspecs/pharma/` (set via `/aw-spec-select-domain pharma`).
-
-## Project Identity (fills the technology base)
-
-- **Project name:** `<SampleProjectName>` — Medicinal Product Registry (Headless API).
-- **Mission:** maintain a centralized, authoritative registry of medicinal products in compliance with pharmaceutical industry standards, regulatory requirements, and healthcare interoperability specifications; exposed as a headless HTTP + FHIR API ready for integration with prescribing, dispensing, manufacturing, pharmacovigilance, and clinical systems.
-- **Bounded contexts (modules):** enumerated in `docs/domainspecs/pharma/domain-requirements.md` (project-specific).
-- **Architecture posture:** Modular Monolith with Clean Architecture + DDD; `MedicinalProduct` is the Aggregate Root; each module designed for clean extraction into an independent microservice. **HEADLESS.**
-
-## Regulatory Posture
-
-Built for regulatory compliance **readiness** — auditability, traceability, data integrity, and
-provenance are designed in. Data-integrity expectations follow **ALCOA+** for GxP-relevant
-product records. Identifier standards (NDC), substance identity (UNII), classification (WHO
-ATC), and ISO IDMP concept alignment are first-class. Data residency configurable per deployment.
-
-## Domain Principles
-
-> Extend the technology Core Principles; numbering **continues from XV**.
-
-### XVI — Pharmaceutical Product Identification (NON-NEGOTIABLE)
-NDC modeled as a Value Object with discrete Labeler/Product/Package segments; NDC uniqueness enforced (aggregate + persistence constraint); NDC validation rules configurable; no invented NDC/Labeler codes. The domain model aligns with ISO IDMP concepts (Medicinal Product, Manufactured Item, Pharmaceutical Product, Substance, MAH, Packaging, Strength, Route of Administration).
-→ `docs/domainspecs/pharma/ndc.md`, `idmp.md`
-
-### XVII — Pharma Terminology & Classification (NON-NEGOTIABLE)
-Coded data uses standard terminologies — UNII (substances), RxNorm (clinical drug), SNOMED CT (dose form / route / classification), UCUM (units), and WHO ATC (therapeutic classification). Every coded field is a Codeable value object; lookup/validation via the Terminology module; ATC codes validated against configured code sets (multiple ATC per product allowed); no invented or free-text codes.
-→ `docs/domainspecs/pharma/terminology.md`, `atc.md`
-
-### XVIII — Regulatory Compliance: Audit, Provenance & Versioning (NON-NEGOTIABLE)
-Immutable audit records (User, Timestamp, Action, Previous Value, New Value) for product creation, modification, retirement, identifier changes, and classification changes; `AuditRecord` is append-only. Provenance captured for externally sourced product data (source, method, agent, timestamp). Full version history of product information; historical versions remain queryable. Extends technology **X** and **XIV** with pharma compliance controls.
-→ `docs/domainspecs/pharma/regulatory-compliance.md`, `data-provenance.md`, `auditing.domain.md`, `persistence.domain.md`
-
-### XIX — Medicinal Product Lifecycle Integrity (NON-NEGOTIABLE)
-MedicinalProduct lifecycle (Draft → Under Review → Approved → Active → Discontinued/Withdrawn) is a guarded state machine; only valid transitions are permitted; registration completeness (required attributes, ≥ 1 active ingredient, ≥ 1 packaging, valid NDC/dosage-form/route/ATC) is enforced before leaving Draft; retirement is a logical state change, never a hard delete. Each transition emits a domain event and is audit-mandatory.
-→ `docs/domainspecs/pharma/product-lifecycle.domain.md`, `domain-driven-design.domain.md`, `eventing.domain.md`
-
-### XX — Healthcare Interoperability Readiness
-The model maps to FHIR Medication / MedicationKnowledge / Substance / Organization (projections, not the system of record); product identifiers map to FHIR Identifier; coded fields map to CodeableConcept/Coding; the solution supports future HL7-based integration via Interop adapters. Extends technology **XII** and **XIV** with the FHIR contract.
-→ `docs/domainspecs/pharma/fhir.md`, `hl7.md`
-
-## Folder Structure Additions
-
-- Pharma additions (Interop/Fhir + Hl7v2 adapters, InteropTests, terminology seed fixtures, provenance/version-history stores): `docs/domainspecs/pharma/folder-structure.domain.md`
-
-## Security & Governance Addenda
-
-- **Change authority** (who may register / approve / retire products, and change identifiers or classification): `docs/domainspecs/pharma/authorization.domain.md`
-- **Data classification** (public vs commercially-sensitive / pre-market / externally-sourced; GxP/ALCOA+ integrity): `docs/domainspecs/pharma/data-classification.domain.md`
-- **Zero-trust posture** (transport, scope/trace propagation, change-authority enforcement): `docs/domainspecs/pharma/zero-trust.domain.md`
-- **Coding standards** (forbidden patterns, quality gates): `docs/domainspecs/pharma/coding-standards.domain.md`
-- **API/contract versioning** (FHIR + NDC identifier stability): `docs/domainspecs/pharma/api-versioning.domain.md`
-- **Dependency policy** (FHIR SDK, terminology libraries, regulatory suitability): `docs/domainspecs/pharma/dependency-policy.domain.md`
-
-## AI Rules Addenda
-
-- Identifier/code safety (no invented NDC/UNII/RxNorm/SNOMED/ATC), projection discipline, lifecycle/audit edit limits, pharma refusal conditions: `docs/domainspecs/pharma/ai-rules.domain.md` (extends `docs/glossary/ai-rules.md`)
-
-## Governance Overrides
-
-- Mandatory approver for any identifier (NDC), classification (ATC), or lifecycle-rule change: Regulatory/Compliance Officer (in addition to a Principal Engineer and a Domain Owner). Change-authority roles are defined in `docs/domainspecs/pharma/authorization.domain.md`.
-- Additional review required after every relevant regulatory or terminology-release update (e.g. WHO ATC annual update, FDA NDC directory changes).
-- **Versioning note:** any change to NDC identity rules, the lifecycle state machine, the audit-record shape, or the canonical FHIR interoperability surface is a MAJOR bump.
-
-## Domain Requirements Pointer
-
-→ `docs/domainspecs/pharma/domain-requirements.md`
-(`[DOMAIN: Bounded Contexts / Modules]`, per-subsection pointers, `[DOMAIN: Platform Topology]`, `[DOMAIN: Governance Overrides]`).