aw-spec-cli 0.1.4 → 0.1.6

package/assets/docs/domainspecs/pharma/comandrulemap.md

@@ -1,186 +0,0 @@
-# Pharma Domain — Command → Rule-File Map
-
-Per-AW-Spec-command list of the **pharma domain** rule files in this folder.
-Technology standards already auto-load inside each command; the files below are the
-domain-specific ones to load **in addition** for a medicinal-product-registration project.
-
-- All paths are workspace-relative and live in this folder: `docs/domainspecs/pharma/`.
-- A skill can read this file and load every path under the matching command heading.
-- This file is the **canonical source** for the pharma domain mapping; `/aw-spec-select-domain`
-  selects this folder as active.
-
----
-
-## /aw-spec-constitution
-- docs/domainspecs/pharma/domain-requirements.md
-- docs/domainspecs/pharma/regulatory-compliance.md
-- docs/domainspecs/pharma/ai-rules.domain.md
-
-## /aw-spec-specify
-- docs/domainspecs/pharma/domain-requirements.md
-- docs/domainspecs/pharma/pharma-terms.md
-- docs/domainspecs/pharma/integration-terms.md
-- docs/domainspecs/pharma/domain-driven-design.domain.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/idmp.md
-- docs/domainspecs/pharma/terminology.md
-- docs/domainspecs/pharma/atc.md
-- docs/domainspecs/pharma/fhir.md
-- docs/domainspecs/pharma/hl7.md
-- docs/domainspecs/pharma/regulatory-compliance.md
-- docs/domainspecs/pharma/data-provenance.md
-- docs/domainspecs/pharma/data-classification.domain.md
-- docs/domainspecs/pharma/ai-rules.domain.md
-
-## /aw-spec-clarify
-- docs/domainspecs/pharma/domain-driven-design.domain.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/terminology.md
-- docs/domainspecs/pharma/atc.md
-- docs/domainspecs/pharma/regulatory-compliance.md
-- docs/domainspecs/pharma/pharma-terms.md
-- docs/domainspecs/pharma/integration-terms.md
-
-## /aw-spec-plan
-- docs/domainspecs/pharma/folder-structure.domain.md
-- docs/domainspecs/pharma/cqrs.domain.md
-- docs/domainspecs/pharma/vertical-slices.domain.md
-- docs/domainspecs/pharma/persistence.domain.md
-- docs/domainspecs/pharma/testing.domain.md
-- docs/domainspecs/pharma/eventing.domain.md
-- docs/domainspecs/pharma/domain-driven-design.domain.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/idmp.md
-- docs/domainspecs/pharma/fhir.md
-- docs/domainspecs/pharma/hl7.md
-- docs/domainspecs/pharma/terminology.md
-- docs/domainspecs/pharma/atc.md
-- docs/domainspecs/pharma/regulatory-compliance.md
-- docs/domainspecs/pharma/data-provenance.md
-- docs/domainspecs/pharma/zero-trust.domain.md
-- docs/domainspecs/pharma/authorization.domain.md
-- docs/domainspecs/pharma/auditing.domain.md
-- docs/domainspecs/pharma/data-classification.domain.md
-- docs/domainspecs/pharma/coding-standards.domain.md
-- docs/domainspecs/pharma/dependency-policy.domain.md
-- docs/domainspecs/pharma/api-versioning.domain.md
-- docs/domainspecs/pharma/ai-rules.domain.md
-
-## /aw-spec-tasks
-- docs/domainspecs/pharma/folder-structure.domain.md
-- docs/domainspecs/pharma/vertical-slices.domain.md
-- docs/domainspecs/pharma/cqrs.domain.md
-- docs/domainspecs/pharma/persistence.domain.md
-- docs/domainspecs/pharma/testing.domain.md
-- docs/domainspecs/pharma/eventing.domain.md
-- docs/domainspecs/pharma/domain-driven-design.domain.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/fhir.md
-- docs/domainspecs/pharma/hl7.md
-- docs/domainspecs/pharma/authorization.domain.md
-- docs/domainspecs/pharma/auditing.domain.md
-- docs/domainspecs/pharma/coding-standards.domain.md
-- docs/domainspecs/pharma/ai-rules.domain.md
-
-## /aw-spec-analyze
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/terminology.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/regulatory-compliance.md
-- docs/domainspecs/pharma/auditing.domain.md
-- docs/domainspecs/pharma/coding-standards.domain.md
-- docs/domainspecs/pharma/ai-rules.domain.md
-
-## /aw-spec-implement
-- docs/domainspecs/pharma/folder-structure.domain.md
-- docs/domainspecs/pharma/vertical-slices.domain.md
-- docs/domainspecs/pharma/cqrs.domain.md
-- docs/domainspecs/pharma/persistence.domain.md
-- docs/domainspecs/pharma/testing.domain.md
-- docs/domainspecs/pharma/eventing.domain.md
-- docs/domainspecs/pharma/domain-driven-design.domain.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/idmp.md
-- docs/domainspecs/pharma/fhir.md
-- docs/domainspecs/pharma/hl7.md
-- docs/domainspecs/pharma/terminology.md
-- docs/domainspecs/pharma/atc.md
-- docs/domainspecs/pharma/regulatory-compliance.md
-- docs/domainspecs/pharma/data-provenance.md
-- docs/domainspecs/pharma/authorization.domain.md
-- docs/domainspecs/pharma/auditing.domain.md
-- docs/domainspecs/pharma/data-classification.domain.md
-- docs/domainspecs/pharma/zero-trust.domain.md
-- docs/domainspecs/pharma/coding-standards.domain.md
-- docs/domainspecs/pharma/dependency-policy.domain.md
-- docs/domainspecs/pharma/api-versioning.domain.md
-- docs/domainspecs/pharma/ai-rules.domain.md
-
-## /aw-spec-fast-implement
-
-> Fast path that collapses plan + tasks + analyze + implement into one pass. This list is the
-> **deduplicated union** of those four commands' headings above (here, equal to `/aw-spec-plan`).
-> Load it **once** for the whole pass — do not reload per phase.
-
-- docs/domainspecs/pharma/folder-structure.domain.md
-- docs/domainspecs/pharma/cqrs.domain.md
-- docs/domainspecs/pharma/vertical-slices.domain.md
-- docs/domainspecs/pharma/persistence.domain.md
-- docs/domainspecs/pharma/testing.domain.md
-- docs/domainspecs/pharma/eventing.domain.md
-- docs/domainspecs/pharma/domain-driven-design.domain.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/idmp.md
-- docs/domainspecs/pharma/fhir.md
-- docs/domainspecs/pharma/hl7.md
-- docs/domainspecs/pharma/terminology.md
-- docs/domainspecs/pharma/atc.md
-- docs/domainspecs/pharma/regulatory-compliance.md
-- docs/domainspecs/pharma/data-provenance.md
-- docs/domainspecs/pharma/zero-trust.domain.md
-- docs/domainspecs/pharma/authorization.domain.md
-- docs/domainspecs/pharma/auditing.domain.md
-- docs/domainspecs/pharma/data-classification.domain.md
-- docs/domainspecs/pharma/coding-standards.domain.md
-- docs/domainspecs/pharma/dependency-policy.domain.md
-- docs/domainspecs/pharma/api-versioning.domain.md
-- docs/domainspecs/pharma/ai-rules.domain.md
-
-## /aw-spec-minimal-implementation
-
-> Single-step set for pharma — the **per-domain knob** (edit freely). `/aw-spec-minimal-implementation`
-> loads these to interpret and implement the requirement in one pass; genuinely-external runtime
-> services (terminology server, FHIR endpoint) are stubbed behind ports. For an audited build use
-> `## /aw-spec-fast-implement`.
-
-- docs/domainspecs/pharma/pharma-terms.md
-- docs/domainspecs/pharma/domain-driven-design.domain.md
-- docs/domainspecs/pharma/folder-structure.domain.md
-- docs/domainspecs/pharma/cqrs.domain.md
-- docs/domainspecs/pharma/vertical-slices.domain.md
-- docs/domainspecs/pharma/product-lifecycle.domain.md
-- docs/domainspecs/pharma/ndc.md
-- docs/domainspecs/pharma/idmp.md
-- docs/domainspecs/pharma/atc.md
-
----
-
-## Quick reference (command → file count)
-
-| Command | Domain rule files |
-|---|---|
-| /aw-spec-constitution | 3 |
-| /aw-spec-specify | 15 |
-| /aw-spec-clarify | 8 |
-| /aw-spec-plan | 24 |
-| /aw-spec-tasks | 15 |
-| /aw-spec-analyze | 7 |
-| /aw-spec-implement | 24 |
-| /aw-spec-fast-implement | 24 |
-| /aw-spec-minimal-implementation | 9 |

package/assets/docs/domainspecs/pharma/cqrs.domain.md

@@ -1,16 +0,0 @@
-# CQRS — Pharma Domain Addenda
-
-> Technology base: [[cqrs]]. Commands: `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Pipeline
-- Append a **product-audit behavior** to the mediator pipeline: every create/modify/retire/re-identify/reclassify command on `MedicinalProduct` MUST emit an immutable audit record (User, Timestamp, Action, Previous Value, New Value). See [[auditing.domain]], [[regulatory-compliance]].
-
-## Commands & queries
-- Registration, lifecycle transitions, ingredient/packaging edits, identifier & classification changes = **commands**; each publishes its domain event (see [[eventing.domain]], [[product-lifecycle.domain]]).
-- Product lookup, version history, FHIR projections = **queries** via `IReadRepository<MedicinalProduct>` + a `Specification` (see [[persistence.domain]]).
-
-## Error codes
-`medicinal-product.not_found` · `ndc.duplicate` · `ndc.invalid_format` · `dosage-form.invalid` · `route.invalid` · `atc.invalid_code` · `lifecycle.invalid_transition` · `concurrency.conflict`.
-
-## Related
-- [[cqrs]] · [[auditing.domain]] · [[eventing.domain]] · [[product-lifecycle.domain]] · [[persistence.domain]] · [[domain-driven-design.domain]] · [[regulatory-compliance]]

package/assets/docs/domainspecs/pharma/data-classification.domain.md

@@ -1,24 +0,0 @@
-# Data Classification — Pharma Domain Addenda
-
-> Technology base: [[data-classification]]. Commands: `/aw-spec-specify`, `/aw-spec-plan`, `/aw-spec-implement`.
-
-> No PHI — the model is commercial confidentiality, regulatory integrity, and source trust.
-
-## Categories
-| Class | Extra rules |
-|---|---|
-| **Public / Published** (NDC-directory disclosure level) | Projectable via the public FHIR surface once `MarketingStatus` is active |
-| **Commercially-Sensitive** (pre-market formulations, proprietary strengths, unpublished products) | Access-restricted; **MUST NOT** be on the public FHIR surface until marketing status permits |
-| **Regulatory-Submission** (MA dossier refs, regulator keys) | Restricted; audited access (see [[auditing.domain]]) |
-| **Externally-Sourced** (FDA NDC / RxNorm / WHO ATC / partner feeds) | Carries a `ProvenanceRecord`; still validated (see [[data-provenance]]) |
-
-## Data integrity (GxP / ALCOA+)
-- GxP records satisfy **ALCOA+** (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available), enforced via immutable audit, provenance, version history (see [[auditing.domain]], [[data-provenance]], [[persistence.domain]], [[regulatory-compliance]]).
-
-## Exposure & logging
-- `Draft`/`Under Review` or non-public `MarketingStatus` products MUST NOT be published on the public FHIR/REST surface (see [[product-lifecycle.domain]], [[fhir]]).
-- Externally-sourced values are never published without passing validation (see [[ndc]], [[atc]], [[terminology]]).
-- Commercially-sensitive pre-market details MUST NOT appear in logs/metrics/traces — log the product ID only (see [[coding-standards.domain]]).
-
-## Related
-- [[data-classification]] · [[data-provenance]] · [[auditing.domain]] · [[persistence.domain]] · [[regulatory-compliance]] · [[product-lifecycle.domain]] · [[authorization.domain]] · [[coding-standards.domain]] · [[ndc]] · [[atc]] · [[fhir]]

package/assets/docs/domainspecs/pharma/data-provenance.md

@@ -1,21 +0,0 @@
-# Data Provenance Standards — Pharma
-
-> NON-NEGOTIABLE. Commands: `/aw-spec-specify`, `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## First-class concern
-- Any product attribute imported from an external source (FDA NDC directory, RxNorm, WHO ATC, an MAH submission, a partner feed) SHALL carry a **`ProvenanceRecord`** (Provenance module).
-- Provenance is captured at ingestion through the Interop adapters — never back-filled by guessing (see [[hl7]], [[fhir]], [[ai-rules.domain]]).
-
-## Record (minimum)
-```
-{ source, sourceSystem, sourceVersion, method, agent, timestamp, importedFields[], correlationId }
-```
-- **sourceVersion** = originating authority's release/version (e.g. terminology edition; see [[terminology]], [[atc]]); **method** = automated import / manual entry / API sync; **agent** = responsible principal.
-
-## Integrity
-- Complements audit (who/when/what; see [[auditing.domain]]) and version history (see [[persistence.domain]]).
-- Provenance does **not** exempt an NDC/ATC/UNII value from validation (see [[ndc]], [[atc]], [[terminology]]).
-- MAY project to the FHIR `Provenance` resource (see [[fhir]]).
-
-## Related
-- [[auditing.domain]] · [[persistence.domain]] · [[terminology]] · [[ndc]] · [[atc]] · [[fhir]] · [[regulatory-compliance]] · [[ai-rules.domain]]

package/assets/docs/domainspecs/pharma/dependency-policy.domain.md

@@ -1,11 +0,0 @@
-# Dependency Policy — Pharma Domain Addenda
-
-> Technology base: [[dependency-policy]]. Commands: `/aw-spec-plan`, `/aw-spec-implement`.
-
-## Reviews & libraries
-- Every new dependency gets a **regulatory-suitability** review beyond the generic license/supply-chain check — reject packages that phone home or ship analytics by default (leak risk for commercially-sensitive pre-market data) (see [[data-classification.domain]]).
-- FHIR: the **official FHIR .NET SDK**, version-matched to the endpoint (R4/R5; see [[fhir]]).
-- Terminology integrations (RxNorm/SNOMED/UNII/ATC/NDC) go through the Terminology module; client libraries added **only** on explicit developer request — no AI-introduced terminology/interop dependencies (see [[terminology]], [[hl7]], [[ai-rules.domain]]).
-
-## Related
-- [[dependency-policy]] · [[fhir]] · [[hl7]] · [[terminology]] · [[data-classification.domain]] · [[ai-rules.domain]]

package/assets/docs/domainspecs/pharma/domain-driven-design.domain.md

@@ -1,36 +0,0 @@
-# Domain-Driven Design — Medicinal Product Domain Model
-
-> Technology base: [[domain-driven-design]]. NON-NEGOTIABLE. Commands: `/aw-spec-specify`, `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Modeling
-- Use the pharma/regulatory ubiquitous language (see [[pharma-terms]]), aligned to ISO IDMP concepts (see [[idmp]]).
-- FHIR- and IDMP-aligned, but **FHIR resources are projections, not the system of record** (see [[fhir]]); the aggregate is authoritative.
-- Coded concepts use industry terminologies, never free text (see [[terminology]]); coded VOs follow the FHIR pattern (`Codeable`, `Coding`, `Quantity`, `Ratio`, `Identifier`).
-
-## Aggregate Root
-- **`MedicinalProduct` is the Aggregate Root.** All product data (ingredients, packaging, marketing authorization, identifiers, classification, lifecycle state) is reached/modified **through** it; no external code mutates a contained entity directly. Invariants are enforced atomically; state changes raise domain events (see [[eventing.domain]]).
-
-## Value Objects (immutable, equality by value)
-`NdcCode` · `ProductName` · `GenericName` · `Strength` · `DosageForm` · `RouteOfAdministration` · `AtcCode` · `MarketingStatus` · `PackageIdentifier`
-- `NdcCode`/`PackageIdentifier` — segmented, format-validated, unique (see [[ndc]]).
-- `Strength` — numerator/denominator `Quantity` with UCUM units; `DosageForm`/`RouteOfAdministration`/`AtcCode` — coded against configured value sets (see [[terminology]], [[atc]]).
-
-## Entities (identity within the aggregate)
-- **`ActiveIngredient`** — Name, UNII, Strength, Strength Unit. **>= 1 required.**
-- **`PackagingConfiguration`** — Package NDC, Description, Quantity, Unit of Measure. **>= 1 required.**
-- **`MarketingAuthorization`** — authorization granted to the MAH by a regulator (see [[idmp]]).
-
-## Invariants
-- **MedicinalProduct** — NDC unique + format-valid (invalid blocks persistence); >= 1 ActiveIngredient + >= 1 PackagingConfiguration; all required attributes enforced at registration; dosage form/route must be valid coded values; lifecycle transitions must be valid (see [[product-lifecycle.domain]]); identifier/classification changes are audit-mandatory + emit events (see [[auditing.domain]], [[eventing.domain]]).
-- **PackagingConfiguration** — Package NDC unique within and across products (see [[ndc]]).
-- **ActiveIngredient** — Strength + Strength Unit required; UNII validated where supplied (see [[terminology]]).
-- **AuditRecord** — append-only; no update/delete (see [[auditing.domain]]).
-
-## Validation summary
-NDC format; required attributes; duplicate identifiers; invalid dosage forms; invalid routes; invalid lifecycle transitions (see [[ndc]], [[terminology]], [[product-lifecycle.domain]]).
-
-## AI guidance
-See [[ai-rules.domain]] — confirm signatures, use the official FHIR SDK, never invent NDC/UNII/RxNorm/SNOMED/ATC codes, keep FHIR as projections.
-
-## Related
-- [[domain-driven-design]] · [[product-lifecycle.domain]] · [[ndc]] · [[idmp]] · [[atc]] · [[terminology]] · [[fhir]] · [[eventing.domain]] · [[auditing.domain]] · [[persistence.domain]] · [[pharma-terms]] · [[ai-rules.domain]]

package/assets/docs/domainspecs/pharma/domain-requirements.md

@@ -1,99 +0,0 @@
-# DOMAIN REQUIREMENTS (project-specific)
-
-> Project-specific input, **updated independently per project**. The engineering constitution
-> stays domain-agnostic and supreme; this file holds the per-project enumeration and headline
-> profiles for the **Medicinal Product Registration** domain. Detailed domain *rules* are
-> expanded in the sibling files in this folder.
->
-> Replace `<SampleProjectName>` and the bounded-context list below for a new project.
-
-=====================================================================
-[DOMAIN: Bounded Contexts / Modules]
-=====================================================================
-- ProductRegistry — aggregate root: **MedicinalProduct**; owns ActiveIngredient,
-  PackagingConfiguration, MarketingAuthorization entities and the product value objects
-  (NdcCode, ProductName, GenericName, Strength, DosageForm, RouteOfAdministration, AtcCode,
-  MarketingStatus, PackageIdentifier). See [[domain-driven-design.domain]].
-- Substances — aggregates: Substance, ActiveMoiety; UNII-keyed ingredient identity
-  (see [[terminology]]).
-- Organizations — aggregates: Organization, MarketingAuthorizationHolder, Manufacturer,
-  Labeler. Maps to FHIR `Organization` (see [[fhir]]).
-- Classification — aggregates: AtcClassification, ProductClassification; ATC code sets and
-  SNOMED CT classification references (see [[atc]], [[terminology]]).
-- Terminology — aggregates: CodeSystem, ValueSet, ConceptMap (project-managed subsets;
-  expansions cached from external terminology services). Backs NDC/ATC/UNII/SNOMED/RxNorm
-  validation (see [[terminology]]).
-- Lifecycle — the MedicinalProduct state machine (Draft → Under Review → Approved → Active →
-  Discontinued → Withdrawn) and its transition guards (see [[product-lifecycle.domain]]).
-- Interoperability — aggregates: FhirProjection, IntegrationEndpoint; FHIR Medication /
-  MedicationKnowledge / Substance / Organization projections and HL7 readiness
-  (see [[fhir]], [[hl7]]).
-- Provenance — aggregate: ProvenanceRecord for externally sourced product data
-  (see [[data-provenance]]).
-- Auditing — aggregate: AuditRecord (append-only). Captures creation, modification,
-  retirement, identifier and classification changes (see [[auditing.domain]]).
-
-=====================================================================
-[DOMAIN: subsection pointers]
-=====================================================================
-[DOMAIN: Standards — NDC]                      -> docs/domainspecs/pharma/ndc.md
-[DOMAIN: Standards — ISO IDMP]                 -> docs/domainspecs/pharma/idmp.md
-[DOMAIN: Standards — ATC]                      -> docs/domainspecs/pharma/atc.md
-[DOMAIN: Standards — Terminology]              -> docs/domainspecs/pharma/terminology.md
-[DOMAIN: Interop — FHIR]                       -> docs/domainspecs/pharma/fhir.md
-[DOMAIN: Interop — HL7]                        -> docs/domainspecs/pharma/hl7.md
-[DOMAIN: Aggregates and Business Invariants]   -> docs/domainspecs/pharma/domain-driven-design.domain.md
-[DOMAIN: Product Lifecycle]                    -> docs/domainspecs/pharma/product-lifecycle.domain.md
-[DOMAIN: Regulatory / Compliance]              -> docs/domainspecs/pharma/regulatory-compliance.md
-[DOMAIN: Data Provenance]                      -> docs/domainspecs/pharma/data-provenance.md
-[DOMAIN: Audit Profile]                        -> docs/domainspecs/pharma/auditing.domain.md
-[DOMAIN: Persistence / Versioning Profile]     -> docs/domainspecs/pharma/persistence.domain.md
-[DOMAIN: Eventing Profile]                     -> docs/domainspecs/pharma/eventing.domain.md
-[DOMAIN: Testing Profile]                      -> docs/domainspecs/pharma/testing.domain.md
-[DOMAIN: Security Profile]                     -> docs/domainspecs/pharma/authorization.domain.md, docs/domainspecs/pharma/data-classification.domain.md, docs/domainspecs/pharma/zero-trust.domain.md
-[DOMAIN: Coding Standards Profile]             -> docs/domainspecs/pharma/coding-standards.domain.md
-[DOMAIN: CQRS / Vertical Slices Profile]       -> docs/domainspecs/pharma/cqrs.domain.md, docs/domainspecs/pharma/vertical-slices.domain.md
-[DOMAIN: Folder Structure Profile]             -> docs/domainspecs/pharma/folder-structure.domain.md
-[DOMAIN: API Versioning Profile]               -> docs/domainspecs/pharma/api-versioning.domain.md
-[DOMAIN: Dependency Policy Profile]            -> docs/domainspecs/pharma/dependency-policy.domain.md
-[DOMAIN: Integration Terms]                    -> docs/domainspecs/pharma/integration-terms.md
-[DOMAIN: AI Policy Addenda]                    -> docs/domainspecs/pharma/ai-rules.domain.md
-[DOMAIN: Ubiquitous Language]                  -> docs/domainspecs/pharma/pharma-terms.md
-[DOMAIN: Platform Topology]                    -> below
-
-=====================================================================
-[DOMAIN: Platform Topology]
-=====================================================================
-- Target runtime: Kubernetes (AKS, EKS, or on-prem). Single-region by default; multi-region
-  active/passive for DR.
-- External dependencies (Aspire resources): PostgreSQL (primary product registry), Redis
-  (cache for terminology expansions + read models), a message broker (Azure Service Bus,
-  AWS SQS/SNS, or RabbitMQ) for CloudEvents, an OTel collector, the configured IdP, an external
-  Terminology Service (NDC/RxNorm/SNOMED/UNII/ATC value-set expansion, optional), a FHIR
-  validator container, and an object store (S3/Blob) for imported source documents / labels.
-- Scale targets: P95 read latency < 200 ms at 200 RPS per module; FHIR search P95 < 500 ms.
-- Disaster recovery: RPO <= 15 minutes, RTO <= 4 hours; daily encrypted backups with 35-day
-  retention plus monthly archive. Product registry and audit history are retention-protected
-  (see [[persistence.domain]], [[auditing.domain]]).
-
-=====================================================================
-[DOMAIN: Governance Overrides]
-=====================================================================
-- Principal Engineers (approvers): TBD — fill at ratification.
-- Regulatory / Compliance Officer (mandatory approver for any identifier, classification, or
-  lifecycle-rule change): TBD.
-- Domain Owners (per module): TBD — assign one regulatory and one technical owner per bounded
-  context.
-- Quarterly review cadence: first business week of each quarter; an additional review after
-  every relevant regulatory or terminology-release update (e.g. WHO ATC annual update, FDA NDC
-  directory changes).
-- Exception process: a time-boxed waiver via a Waiver Request issue, approved by a Principal
-  Engineer + the Compliance Officer, with a mandatory expiry <= 90 days and a remediation plan
-  recorded in the issue.
-
-## Related
-
-- [[domain-driven-design.domain]] · [[product-lifecycle.domain]] · [[ndc]] · [[idmp]] ·
-  [[atc]] · [[terminology]] · [[fhir]] · [[hl7]] · [[regulatory-compliance]] ·
-  [[data-provenance]] · [[auditing.domain]] · [[persistence.domain]] · [[ai-rules.domain]] ·
-  [[pharma-terms]]

package/assets/docs/domainspecs/pharma/eventing.domain.md

@@ -1,18 +0,0 @@
-# Eventing — Pharma Domain Addenda
-
-> Technology base: [[eventing]]. Commands: `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Domain events
-- `MedicinalProduct` raises domain events on every significant state change — the integration seam to downstream consumers (prescribing, dispensing, manufacturing, pharmacovigilance, clinical).
-- Events publish from the aggregate boundary, never by an external feed writing aggregates directly (see [[hl7]], [[domain-driven-design.domain]]).
-
-## Canonical events
-`MedicinalProductRegistered` (Draft) · `…SubmittedForReview`/`Approved`/`Activated`/`Discontinued`/`Withdrawn` (lifecycle, see [[product-lifecycle.domain]]) · `ProductIdentifierChanged` (NDC, see [[ndc]]) · `ProductClassificationChanged` (ATC, see [[atc]]) · `ActiveIngredientChanged`/`PackagingConfigurationChanged` · `MarketingStatusChanged`. Each = an audit-mandatory operation (see [[auditing.domain]]).
-
-## Delivery
-- Outbox pattern: events persisted transactionally with the aggregate change, published to CloudEvents. Consumers integrate via FHIR / REST / event stream — **direct DB access FORBIDDEN** (see [[fhir]]).
-- Payloads carry coded values via standard terminologies, never free text (see [[terminology]], [[ndc]], [[atc]]).
-- Each event carries a `correlationId` tying command → audit record → version snapshot (see [[auditing.domain]], [[persistence.domain]], [[regulatory-compliance]]).
-
-## Related
-- [[eventing]] · [[domain-driven-design.domain]] · [[product-lifecycle.domain]] · [[auditing.domain]] · [[persistence.domain]] · [[fhir]] · [[hl7]] · [[ndc]] · [[atc]] · [[terminology]]

package/assets/docs/domainspecs/pharma/fhir.md

@@ -1,31 +0,0 @@
-# FHIR Standards — Pharma
-
-> NON-NEGOTIABLE. Commands: `/aw-spec-specify`, `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Architecture & projectors
-- **R4 default**; R5 **additive** under `/fhir/R5/...`. FHIR is the canonical interop contract; it + any internal REST serve from the **same authoritative aggregates** — no duplicate write paths.
-- **FHIR resources are PROJECTIONS, NOT the system of record** — `MedicinalProduct` is authoritative (see [[domain-driven-design.domain]]).
-- Mapping in `{Module}/Interop/Fhir/<Resource>Projector.cs`, hand-written + round-trip tested (see [[testing.domain]]). A second FHIR write path bypassing the aggregate is FORBIDDEN; FHIR representations MUST NOT replace internal DTOs.
-
-## Resource mappings
-| Domain concept | FHIR resource |
-|---|---|
-| `MedicinalProduct` (dispensable identity) | **Medication** |
-| `MedicinalProduct` (classification/packaging/regulatory) | **MedicationKnowledge** |
-| `Substance` / `ActiveIngredient` | **Substance** |
-| `MarketingAuthorizationHolder` / `Manufacturer` / `Labeler` | **Organization** |
-
-- Identifiers → FHIR `Identifier` (`NdcCode` with NDC system URI; IDMP MPID/PhPID where adopted; see [[ndc]], [[idmp]]).
-- Names → `Medication.code` + name elements; coded fields → `CodeableConcept`/`Coding` (see [[terminology]]); ATC codings carry the ATC system URI (see [[atc]]).
-- `Strength` → `Medication.ingredient.strength` (`Ratio` of `Quantity`); `DosageForm` → `Medication.form`; route + packaging → `MedicationKnowledge`.
-
-## Conformance
-- FHIR types from the **official FHIR .NET SDK**, version-matched (R4/R5) (see [[ai-rules.domain]]).
-- Declare profiles/extensions/value-sets in `StructureDefinition` resources; FHIR validator passes for every modified resource/profile/example (CI gate).
-- Publish `CapabilityStatement` at `/fhir/metadata` (diff reviewed); `/metadata` + `/.well-known` may be `AllowAnonymous()`.
-
-## Bundle / search / concurrency
-- Bundle/searchset semantics (`_count`, `_offset`/`_page`, `_total`); errors via `OperationOutcome` (HTTP 422); `If-Match` → FHIR **weak** ETag at the projection boundary (see [[persistence.domain]]).
-
-## Related
-- [[domain-driven-design.domain]] · [[terminology]] · [[ndc]] · [[idmp]] · [[atc]] · [[hl7]] · [[integration-terms]] · [[persistence.domain]] · [[testing.domain]] · [[ai-rules.domain]]

package/assets/docs/domainspecs/pharma/folder-structure.domain.md

@@ -1,24 +0,0 @@
-# Folder Structure — Pharma Domain Addenda
-
-> Technology base: [[folder-structure]]. Commands: `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`. Replace `<SampleProjectName>`.
-
-## Additions to the base layout
-```
-src/<SampleProjectName>.Service/
-  Infrastructure/Security/      auth handlers, scope evaluators, change-authority checks
-  Infrastructure/Auditing/      immutable product-audit emitter (FHIR AuditEvent shape)
-  ProductRegistry/Domain/<ValueObject>.cs   NdcCode, AtcCode, Strength, DosageForm, ...
-  ProductRegistry/Domain/MedicinalProduct.cs   aggregate root  (see [[domain-driven-design.domain]])
-  ProductRegistry/Interop/Fhir/   Medication/MedicationKnowledge/Substance/Organization projectors  (see [[fhir]])
-  ProductRegistry/Interop/Hl7v2/  inbound parsers + outbound emitters (when needed)   (see [[hl7]])
-  Terminology/                  CodeSystem/ValueSet/ConceptMap + seed (NDC/RxNorm/SNOMED/UNII/ATC)  (see [[terminology]])
-  Provenance/                   ProvenanceRecord store for external data   (see [[data-provenance]])
-tests/<SampleProjectName>.InteropTests/   FHIR-validator conformance              (see [[testing.domain]])
-tests/<SampleProjectName>.TestFixtures/   synthetic/test NDC + terminology sentinels  (see [[testing.domain]])
-docs/interop/fhir-implementation-guide/ · docs/regulatory/compliance-controls.md
-```
-- `Interop/` adapters translate to/from internal commands + projections (see [[vertical-slices.domain]]).
-- Coded VOs follow the FHIR pattern (see [[terminology]], [[coding-standards.domain]]); version history + audit store are retention-protected (see [[persistence.domain]], [[auditing.domain]]).
-
-## Related
-- [[folder-structure]] · [[fhir]] · [[hl7]] · [[terminology]] · [[data-provenance]] · [[testing.domain]] · [[vertical-slices.domain]] · [[domain-driven-design.domain]]

package/assets/docs/domainspecs/pharma/hl7.md

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-# HL7 Integration Readiness — Pharma
-
-> Commands: `/aw-spec-specify`, `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Principle
-- The solution SHALL support **future integration with HL7-based systems**. The registry is the authoritative product source; HL7 surfaces are **adapters, not a parallel model**. FHIR is the primary contract (see [[fhir]]); HL7 v2 adapters are added where a downstream system (prescribing/dispensing/manufacturing/pharmacovigilance) needs them.
-
-## Adapter patterns
-- Inbound/outbound adapters live in `{Module}/Interop/Hl7v2/`; translate via `IMediator` — **MUST NOT** write aggregates directly (see [[eventing.domain]], [[domain-driven-design.domain]]). Bypassing them from an external feed is an AI refusal condition (see [[ai-rules.domain]]).
-- The egress adapter converts domain events (e.g. `MedicinalProductActivated`, `ClassificationChanged`) to outbound messages; conformance tested against an internal corpus (see [[testing.domain]]).
-- Codes in HL7 messages use standard terminologies (NDC, RxNorm, UNII, ATC) — never free text (see [[terminology]], [[ndc]], [[atc]]).
-
-## Future surfaces
-- Pharmacovigilance (ICH E2B/ICSR), manufacturing, dispensing integrations are **additive** — consume via FHIR / REST / CloudEvents; **direct DB access FORBIDDEN** (see [[eventing.domain]]).
-
-## Related
-- [[fhir]] · [[eventing.domain]] · [[terminology]] · [[ndc]] · [[atc]] · [[integration-terms]] · [[domain-driven-design.domain]] · [[testing.domain]] · [[ai-rules.domain]]

package/assets/docs/domainspecs/pharma/idmp.md

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-# ISO IDMP — Identification of Medicinal Products
-
-> NON-NEGOTIABLE. Commands: `/aw-spec-specify`, `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Alignment principle
-- The model SHALL align with the ISO IDMP suite (**ISO 11615/11616/11238/11239/11240**) **where applicable** — IDMP shapes the ubiquitous language + aggregate boundaries; it is **not** a wire format and does not replace the internal model (see [[domain-driven-design.domain]]).
-- Even where IDMP messages aren't yet exchanged, preserve the IDMP concept boundaries so future exchange is additive, not a rewrite.
-
-## Required concepts → model home
-| IDMP concept | Model home |
-|---|---|
-| **Medicinal Product** | `MedicinalProduct` aggregate root |
-| **Manufactured Item** | manufactured dose-form item (within the aggregate or a related entity) |
-| **Pharmaceutical Product** | administrable product = `DosageForm` + `Strength` + `RouteOfAdministration` |
-| **Substance** | `Substance` aggregate, UNII-identified (see [[terminology]]); referenced by `ActiveIngredient` |
-| **Marketing Authorization Holder** | `MarketingAuthorizationHolder` → FHIR `Organization` (see [[fhir]]) |
-| **Packaging** | `PackagingConfiguration` (Package NDC, description, quantity, UoM) (see [[ndc]]) |
-| **Strength** | `Strength` VO (numerator/denominator `Quantity`, UCUM) |
-| **Route of Administration** | `RouteOfAdministration` VO (coded) |
-
-## Identifiers & terminology
-- IDMP identifiers (**MPID**, **PhPID**) SHALL be representable as FHIR `Identifier`-shaped VOs when adopted; they coexist with NDC, not replace it (see [[ndc]]).
-- IDMP controlled vocabularies (dose form, route, units, packaging) bind to the Terminology module's code systems, never free text (see [[terminology]], [[atc]]).
-
-## Related
-- [[domain-driven-design.domain]] · [[ndc]] · [[terminology]] · [[atc]] · [[fhir]] · [[pharma-terms]]

package/assets/docs/domainspecs/pharma/integration-terms.md

@@ -1,21 +0,0 @@
-# Glossary — Integration Terms (Pharma)
-
-> Ubiquitous language for pharma interoperability standards + identifiers. Commands: `/aw-spec-specify`, `/aw-spec-clarify`, `/aw-spec-plan`. See [[pharma-terms]] (aggregates) + [[terminology]] (coding).
-
-| Term | Definition |
-|---|---|
-| **NDC** | US FDA product/package identifier (Labeler + Product + Package); the `NdcCode` VO; format-validated, unique (see [[ndc]]). |
-| **ISO IDMP** | Identification of Medicinal Products (ISO 11615/11616/11238/11239/11240); conceptual alignment; may carry MPID/PhPID (see [[idmp]]). |
-| **UNII** | FDA substance identity for ingredients/moieties; maps to FHIR `Substance.code` (see [[terminology]]). |
-| **RxNorm** | Normalized clinical-drug naming (US); optional product identifier (see [[terminology]]). |
-| **WHO ATC** | Therapeutic class codes; multiple per product, validated against configured sets (see [[atc]]). |
-| **SNOMED CT** | Terminology for dosage forms, routes, product classification (see [[terminology]]). |
-| **UCUM** | Units for strength + package quantity (see [[terminology]]). |
-| **FHIR** | Canonical external contract (R4 default, R5 additive); projects to `Medication`/`MedicationKnowledge`/`Substance`/`Organization` over aggregates (see [[fhir]]). |
-| **HL7** | **HL7 v2.x** legacy messaging via adapters where a consumer needs it; **HL7 FHIR** is the primary contract (see [[hl7]], [[fhir]]). |
-| **Provenance** | Source metadata for externally sourced data; may project to FHIR `Provenance` (see [[data-provenance]]). |
-| **CloudEvents** | CNCF durable async event-stream spec; carries product domain events (see [[eventing.domain]]). |
-| **OpenAPI / CapabilityStatement** | Versioned machine-readable contracts for REST / FHIR (see [[api-versioning.domain]]). |
-
-## Related
-- [[pharma-terms]] · [[terminology]] · [[ndc]] · [[idmp]] · [[atc]] · [[fhir]] · [[hl7]] · [[data-provenance]] · [[eventing.domain]] · [[api-versioning.domain]]

package/assets/docs/domainspecs/pharma/ndc.md

@@ -1,28 +0,0 @@
-# NDC — National Drug Code Standards
-
-> NON-NEGOTIABLE. Commands: `/aw-spec-specify`, `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Value Object
-- **NDC SHALL be a Value Object** (`NdcCode`) — immutable, equality by value (see [[domain-driven-design.domain]]).
-- Product-level NDC lives on `MedicinalProduct`; package-level (`PackageIdentifier` / Package NDC) on each `PackagingConfiguration`.
-- Free-text storage of an NDC is a Forbidden Pattern.
-
-## Segments & format
-- Three segments: **Labeler Code**, **Product Code**, **Package Code** — retain each segment discretely **plus** the canonical formatted string (boundaries MUST NOT be lost to a concatenated string).
-- Common configurations (5-4-2, 5-3-2, 4-4-2 10-digit + the 11-digit normalized form) SHALL be representable as **data, not compiled constants**.
-- The Labeler Code is FDA-assigned to the **Labeler** organization; the registry does not mint Labeler Codes (see [[domain-requirements]]).
-
-## Uniqueness
-- **NDC uniqueness SHALL be enforced** — a product NDC maps to <=1 active `MedicinalProduct`; a Package NDC to <=1 `PackagingConfiguration`.
-- Duplicate detection runs at registration + any identifier change; enforced at the aggregate boundary **and** a persistence-level unique constraint (see [[persistence.domain]], [[auditing.domain]]).
-
-## Validation
-- **NDC validation rules SHALL be configurable** (segment lengths, allowed configurations, check rules = value-set data).
-- Runs on registration, identifier change, and external import (see [[data-provenance]]); an invalid NDC raises a domain error — the Domain MUST NOT persist it.
-- Never invent NDC values or Labeler Codes — validate external codes against the configured rules + FDA NDC directory via the Terminology module (see [[terminology]], [[ai-rules.domain]]).
-
-## FHIR mapping
-- `NdcCode` → FHIR `Identifier` (NDC system URI); also participates in `Medication.code` as a `CodeableConcept` coding (see [[fhir]]).
-
-## Related
-- [[domain-driven-design.domain]] · [[idmp]] · [[terminology]] · [[fhir]] · [[data-provenance]] · [[persistence.domain]] · [[auditing.domain]] · [[ai-rules.domain]]

package/assets/docs/domainspecs/pharma/persistence.domain.md

@@ -1,23 +0,0 @@
-# Persistence — Pharma Domain Addenda
-
-> Technology base: [[persistence]]. NON-NEGOTIABLE. Commands: `/aw-spec-plan`, `/aw-spec-tasks`, `/aw-spec-implement`.
-
-## Version history
-- Maintain a **version history** of product information: each approved change produces a new, immutable **`ProductVersion`** snapshot.
-- **Historical versions remain queryable** — a read model exposes prior versions by product + effective time; superseded versions are never overwritten or purged. Snapshots complement audit (who/what/when; see [[auditing.domain]]) and provenance (source; see [[data-provenance]]).
-
-## Retention-protected data
-- Hard delete FORBIDDEN for `MedicinalProduct` and all product history — delete logically via `MarkAsDeleted(...)` / lifecycle retirement.
-- **Product retirement** (Discontinued/Withdrawn) is a state change, not a delete (see [[product-lifecycle.domain]]).
-- `AuditRecord` is **append-only** — no delete (see [[auditing.domain]]).
-- Retention: registry + version history per regulatory policy (registration lifetime + statutory tail); `AuditRecord` per [[auditing.domain]]; daily encrypted backups.
-
-## Constraints & concurrency
-- Persistence-level **unique constraints** on NDC and Package NDC, beyond the aggregate check (see [[ndc]], [[domain-driven-design.domain]]).
-- Optimistic concurrency token → FHIR **weak** ETag at the projection boundary (see [[fhir]]).
-
-## Dev data
-- Fixtures use synthetic data + **synthetic/clearly-marked test NDCs** — never real identifiers that could collide with the FDA NDC directory (see [[ndc]], [[testing.domain]]).
-
-## Related
-- [[persistence]] · [[auditing.domain]] · [[data-provenance]] · [[product-lifecycle.domain]] · [[ndc]] · [[fhir]] · [[domain-driven-design.domain]] · [[testing.domain]]