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Intended-Use Specification — LQMS as a QMS / Document-Control Tool (TEMPLATE)
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Architecture
Architecture
1. Introduction and Goals
2. Architecture Constraints
3. Context and Scope
4. Solution Strategy
5. Building Block View
6. Runtime View
7. Deployment View
8. Crosscutting Concepts
9. Architecture Decisions
10. Quality Requirements
11. Risks and Technical Debt
12. Glossary
The arrival bundle format
Decisions (ADRs)
Decisions (ADRs)
ADR-0001: Content-Addressed Document Storage with PostgreSQL as Source of Truth
ADR-0002: Single Instance with Scope Hierarchy and Copy-on-Derive
ADR-0003: Fixed Life Cycle States with Configurable Review Processes
ADR-0004: Global Catalogs for Roles and Document Types with Per-Scope Activation
ADR-0005: Modular Monolith
ADR-0006: Three-Layer Search with In-Database Index and Pluggable LLM
ADR-0007: Angular Frontend with Server-Side-Only Enforcement
ADR-0008: Flyway Migrations and jOOQ Codegen from the Migrated Schema
ADR-0009: RLS Enforcement via a Session-Scoped Authorized Scope Set
ADR-0010: Self-Managed QMS via an Internal Mandator
ADR-0011: Authentication via OIDC SSO with Server-Side (BFF) Sessions
ADR-0012: Permission-Based Authorization and System Bootstrap
ADR-0013: User Identity Lifecycle
ADR-0014: Electronic Signatures (Part 11 / Annex 11-Capable)
ADR-0015: Document Effectivity, Periodic Review & Validity
ADR-0016: Data Retention, Disposal & Privacy (FADP / GDPR)
ADR-0017: Multi-Part Version Content
ADR-0018: Non-Functional Targets (Capacity, Availability, Security)
ADR-0019: Notifications & Tasks
ADR-0020: Internationalization (Content Language, Time Zones, Formatting)
ADR-0021: General Typed Document Relationships
ADR-0022: Read-Acknowledgement & Questionnaires
ADR-0023: Migration / Import — Current Released State
ADR-0024: Draft / In-Review Cancellation
ADR-0025: Disposal & Erasure Mechanics (Storage, Index, Backups)
ADR-0026: RLS Runtime Safety — Connection-Pool Scope Isolation
ADR-0027: RLS Boundary — Content-Plane vs Control-Plane
ADR-0028: Stateless Encrypted Token-State Cookie (no server-side session store)
ADR-0029: Document Content Model — Draft-Freeze, Content-Table RLS, Append-Only Audit
ADR-0030: Review & Life-Cycle Realization Model
ADR-0031: Released-base readability enforcement & copy-on-derive mechanics
ADR-0032: Frontend realization — Quinoa, Angular Material, i18n & E2E
ADR-0033: CSRF control for the BFF session — SameSite + JSON content-type
ADR-0034: Notification realization — in-process domain events + system-context fan-out
ADR-0035: Fan-out contract as shipped — gate semantics, count disclosure, audit protocol
ADR-0036: Repository layer — services carry rules, repositories carry jOOQ
ADR-0037: Task scheduler — in-process tick, advisory-lock election, SQL sweep
ADR-0038: Periodic-review realization — derived due date, policy-gated confirmation
ADR-0039: Sweep & periodic-review contract as shipped — grants, guards, addressing
ADR-0040: Disposal-due surfacing — closure-anchored retention, scope-level legal hold
ADR-0041: Email channel & notification i18n — notification-as-outbox, structured messages
ADR-0042: Disposal execution — document tombstoning, single-actor hard-gated destruction
ADR-0043: Disposal blob deletion is post-commit, GC-backstopped
ADR-0044: Search FTS baseline — event-indexed, RLS-scoped search_index
ADR-0045: Image Attachments as Content Parts (Rich-Content Slice R2)
ADR-0046: Four-Eyes — Submitter Excluded from Approval
ADR-0047: Four-Eyes — Submitter-Only Exclusion
ADR-0048: Document Organization — Folder Tree per Scope
ADR-0049: Content Model Round 2 — Type Categories, Template Instantiation, Trace Relations, Completeness Rules
ADR-0050: Live Frontend — SSE State Push, CodeMirror 6, Draft Presence
ADR-0051: In-Text Document Links (doc: Scheme)
ADR-0052: Addressees & Read-Acknowledgement (REQ-TRN Realization)
ADR-0053: Addressees Per Document + Process Owner (amends ADR-0052 K-1)
ADR-0054: Process Owner Is a Role (amends ADR-0053 P-3)
ADR-0055: WYSIWYG Editing Mode over Markdown (editor step R4)
ADR-0056: Visual-Editor Chrome via Milkdown Crepe (gated adoption)
ADR-0057: Content Record Is the ProseMirror Document Tree; Markdown Becomes a Derived Projection
ADR-0058: PM_DOC Is the Only Content Format (pre-production cut; amends ADR-0057 §5)
ADR-0059: Editor Engine Switches to TipTap (spike-gated; supersedes the Milkdown/Crepe choice)
ADR-0060: Backup & Restore — Scripted Ordered Backup with Automated Restore Rehearsal
ADR-0061: CSV — Generated Validation Package per Release
ADR-0062: SBOM — CycloneDX over the Production Layers, Validated Against the Artifact
ADR-0063: User Identity Binds on Subject Only (Issuer Becomes Provenance)
ADR-0064: Per-Document Workflow Role Bindings (Author / Reviewer / Releaser), Enforced
ADR-0065: Diagrams — Excalidraw as the Manual Layer, Mermaid Stays for Text-First/UML
ADR-0066: WITHDRAW — the Author Side May Reclaim a Version from Review
ADR-0067: Review Comments — Anchored, Immutable, Resolvable
ADR-0068: Confluence/Jira QMS Import — Staged, Read-Only, Repeatable
ADR-0069: Arbitrary File Attachments — Download-Only Confinement
ADR-0070: Training Questionnaires — Versioned, Auto-Scored, Release-Gated
ADR-0071: Training Plans — Document Obligations + External Trainings & Certifications
ADR-0072: Diagrams — Self-Hosted draw.io Replaces Excalidraw
ADR-0073: Per-Scope QMS Configuration Surface
ADR-0074: PDF Export of Released Documents — Server-Side via Apache FOP over the Canonical Projection
ADR-0075: Source History Import — Continuity Without Forged Audit
ADR-0076: Periodic-review status visibility (completing MVP gap #2)
ADR-0077: Requirement Items — Keyed Blocks Inside Controlled Documents
ADR-0078: Generalized Trace Items (Traceability Model — Stage A)
ADR-0079: Risk & Risk-Control Items (Traceability Model — Stage B)
ADR-0080: Traceability Workspace — Hub, Sub-Pages, and Role-Gated Views
ADR-0081: Draft-Only Trace-Structure Changes, Server-Enforced
ADR-0082: Table-Shaped Risk Authoring over Risk Blocks
ADR-0083: The TD Dossier — a Versioned, Cross-Scope, Regulatory-Structured Deliverable
ADR-0084: Validation & Regulatory Axes (Traceability Model — Stage C)
ADR-0085: Relation-Layer Consolidation — One Trace Vocabulary, One Surface
ADR-0086: Requirement Traceability Chains — End-to-End Path View + Flat Path Export
ADR-0087: The Scope Traceability Report — One Derived Overview Artifact, Never a Controlled Document
ADR-0088: Verification Evidence Classes — Planned vs. Verified, Derived at the Read Layer
ADR-0089: Recurring Obligations — Periodic Tasks With Record Evidence, Not Calendar Series
ADR-0090: Release & Versioning Policy — Deliberate Releases, One Auditor-Facing Number
ADR-0091: Release Modes — Single-Person Record Release With a Structural Four-Eyes Floor
ADR-0092: Orphan-Blob Garbage Collection With a Quarantine Bin
ADR-0093: One Scope Context — the Toolbar Switcher Is the Only Scope Selector
ADR-0094: Calendar-Anchored Obligation Schedules (Clamped, Never Too Late)
ADR-0095: Key-Rule Governance — Free Until First Use, Then Frozen
ADR-0096: Transition Permissions — Always Visible, Deny Unless Granted
ADR-0097: A Governed Provisioning Surface — MANAGE_SCOPES
ADR-0098: Org Chart × Role System — Marriage at the Evidence Level, Never in Authorization
ADR-0099: The User Manual is an In-App Topic Reference, Not a Document
ADR-0100: LQMS Is the Living Quality Management System
ADR-0101: The Executable Validation Journey (PQ Evidence That Cannot Drift)
ADR-0102: Typed Template Variables (text | date | number — and Deliberately No Enum)
ADR-0103: npm audit Joins the Verification Gate as a Second Standing Input
ADR-0104: The Issued Dossier Is a Persisted Artifact of Record — and Clones to a New Draft
ADR-0105: Navigation Information Architecture — Group by Moment-of-Use
ADR-0106: The Client Reflection Follows Assignments, Not Only Content Reach
ADR-0107: The Audit Append Gate Follows Assignment Reach, Not Content Reach
ADR-0108: Mandator Membership — Invite-Accept, with Pre-Assigned Responsibilities
ADR-0109: Organization Founding Is Its Own Process
ADR-0110: The Audit Trail Is Not a Read Model
ADR-0111: The Imported-Person Model, and Project Portability's First Doctrines
ADR-0112: The Element-Kind Catalog — Semantics in the Model, Not Only in the Code
ADR-0113: Project Arrival Import — Records Arrive as They Are, People Arrive as They Were
ADR-0114: The Operating Model Arrives — Roles as Functions, Names as Words, People as This Instance's Decision
ADR-0115: Collaborative Draft Editing — Two Carets, One Truth, Honest Credit
ADR-0116: The System Maintenance Surface — the App Backs Itself Up, the Host Keeps One Dumb Job
ADR-0117: Role Documentation — a Link, a Finding, Per-Source Recognizers; Substitution Rejected
ADR-0118: The Offline QMS Copy — the Repo Carries the Audit Pack, Not a Second Renderer
ADR-0119: Module-Internal Package Structure — Capabilities First, Layers Second, the Root Is the Surface
ADR-0120: The Shared Kernel — the Domain-Exception Vocabulary Leaves the Authorization Module
ADR-0121: The Project Administrator Role — Per-Scope Administration With Read Access, Seeded in the Base Catalog
ADR-0122: Organization-Level Administration — the Cascade Stays, Becomes Visible, and Founds Projects
ADR-0123: Draft Save-Points — Every Save Restorable, Kept for the Life of the Version
ADR-0124: The Birth Path Completes Without Borrowing Content Clothes
ADR-0125: The Export Twin — Export Emits an Arrival Bundle
ADR-0126: Project Dissolution — the Un-Birth of an Unused Scope
ADR-0127: The Base-QMS Layers — One Library, Derived Adaptations, Local Records
ADR-0128: The GLOBAL Cascade Carries Administration, Never Content
ADR-0129: Role Identity from a GLOBAL Assignment Acts in GLOBAL Alone
ADR-0130: Break-Glass — the Project Administrator's Escalation Is a First-Class, Witnessed, Self-Expiring Act
ADR-0131: Role Substitution as Declared Adoption Edges — Emergency Cover Is Governed, Own-Name, Timed Staffing
ADR-0132: Dual-Hat Reviewer Satisfaction Is a Declared Policy Choice — the Strict Floor Stays the Default
ADR-NNNN:
</span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_5" > <div class="md-nav__link md-nav__container"> <a href="../../../requirements/" class="md-nav__link "> <span class="md-ellipsis"> Requirements </span> </a> <label class="md-nav__link " for="__nav_5" id="__nav_5_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_5_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_5"> <span class="md-nav__icon md-icon"></span> Requirements </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../../requirements/stakeholder_requirements/" class="md-nav__link"> <span class="md-ellipsis"> Stakeholder Requirements </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/gap-analysis/" class="md-nav__link"> <span class="md-ellipsis"> Requirements Gap Analysis </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_admin/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Administration, Permissions & Onboarding </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_api_ui/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: API & User Interface </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_audit_reporting/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Audit Trail & Regulatory Reporting </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_auth/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Authentication & Session </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_backup/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Backup & Restore </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_catalogs/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Catalogs, Roles & Users </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_data_protection/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Data Protection, Retention & Disposal </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_documents/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Documents, Versions & Storage </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_dossiers/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Technical Documentation Dossiers </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_effectivity/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Effectivity, Periodic Review & Validity </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_gspr/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Regulatory Conformity (GSPR / Essential Principles) </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_i18n/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Internationalization </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Life Cycle & Reviews </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_memberships/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Mandator Membership & Invitations </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_migration/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Migration & Import </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_nfr/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Non-Functional </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_notifications/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Notifications & Tasks </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_obligations/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_relationships/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Document Relationships </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_risk/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Risk Management (ISO 14971 Hazards & Controls) </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_sbom/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Software Bill of Materials & Supply-Chain Assurance </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_search/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Search </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_separation/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Scopes, Mandators & Separation </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_signatures/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Electronic Signatures </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_training/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Read-Acknowledgement & Questionnaires </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_users/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: User Identity & Lifecycle </span> </a> </li> <li class="md-nav__item"> <a href="../../../requirements/req_validation/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Design Validation & the Validation Traceability Axis </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_6" > <div class="md-nav__link md-nav__container"> <a href="../../../process/" class="md-nav__link "> <span class="md-ellipsis"> Process (IEC 62304) </span> </a> <label class="md-nav__link " for="__nav_6" id="__nav_6_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_6_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_6"> <span class="md-nav__icon md-icon"></span> Process (IEC 62304) </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../../process/configuration_management_plan/" class="md-nav__link"> <span class="md-ellipsis"> Configuration Management Plan </span> </a> </li> <li class="md-nav__item"> <a href="../../../process/problem_resolution/" class="md-nav__link"> <span class="md-ellipsis"> Problem Resolution Process </span> </a> </li> <li class="md-nav__item"> <a href="../../../process/risk_management/" class="md-nav__link"> <span class="md-ellipsis"> Risk Management </span> </a> </li> <li class="md-nav__item"> <a href="../../../process/software_development_plan/" class="md-nav__link"> <span class="md-ellipsis"> Software Development Plan </span> </a> </li> <li class="md-nav__item"> <a href="../../../process/verification_plan/" class="md-nav__link"> <span class="md-ellipsis"> Verification Plan </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_7" > <label class="md-nav__link" for="__nav_7" id="__nav_7_label" tabindex="0"> <span class="md-ellipsis"> Operations </span> <span class="md-nav__icon md-icon"></span> </label> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_7_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_7"> <span class="md-nav__icon md-icon"></span> Operations </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../../operations/genesis-installation/" class="md-nav__link"> <span class="md-ellipsis"> Genesis: Birthing an LQMS Installation with a Base Library </span> </a> </li> <li class="md-nav__item"> <a href="../../../operations/deployment/" class="md-nav__link"> <span class="md-ellipsis"> LQMS Deployment Guide </span> </a> </li> <li class="md-nav__item"> <a href="../../../operations/server-deployment/" class="md-nav__link"> <span class="md-ellipsis"> LQMS Server Deployment (single Linux host, public HTTPS) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_8" > <div class="md-nav__link md-nav__container"> <a href="../../../traceability/" class="md-nav__link "> <span class="md-ellipsis"> Traceability </span> </a> <label class="md-nav__link " for="__nav_8" id="__nav_8_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_8_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_8"> <span class="md-nav__icon md-icon"></span> Traceability </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../../traceability/matrix/" class="md-nav__link"> <span class="md-ellipsis"> Requirements Traceability Matrix </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--active md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_9" checked> <div class="md-nav__link md-nav__container"> <a href="../../" class="md-nav__link "> <span class="md-ellipsis"> Validation (tool lane) </span> </a> <label class="md-nav__link " for="__nav_9" id="__nav_9_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_9_label" aria-expanded="true"> <label class="md-nav__title" for="__nav_9"> <span class="md-nav__icon md-icon"></span> Validation (tool lane) </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../ai-authorship-posture/" class="md-nav__link"> <span class="md-ellipsis"> AI-Authorship Posture — How LQMS Is Built, and Why the Validation Evidence Does Not Rest on It (TEMPLATE) </span> </a> </li> <li class="md-nav__item md-nav__item--active"> <input class="md-nav__toggle md-toggle" type="checkbox" id="__toc"> <label class="md-nav__link md-nav__link--active" for="__toc"> <span class="md-ellipsis"> Intended-Use Specification — LQMS as a QMS / Document-Control Tool (TEMPLATE) </span> <span class="md-nav__icon md-icon"></span> </label> <a href="./" class="md-nav__link md-nav__link--active"> <span class="md-ellipsis"> Intended-Use Specification — LQMS as a QMS / Document-Control Tool (TEMPLATE) </span> </a> <nav class="md-nav md-nav--secondary" aria-label="Table of contents"> <label class="md-nav__title" for="__toc"> <span class="md-nav__icon md-icon"></span> Table of contents </label> <ul class="md-nav__list" data-md-component="toc" data-md-scrollfix> <li class="md-nav__item"> <a href="#1-purpose-and-regulatory-frame" class="md-nav__link"> <span class="md-ellipsis"> 1. Purpose and regulatory frame </span> </a> </li> <li class="md-nav__item"> <a href="#2-instantiation-fields" class="md-nav__link"> <span class="md-ellipsis"> 2. Instantiation fields </span> </a> </li> <li class="md-nav__item"> <a href="#3-intended-use" class="md-nav__link"> <span class="md-ellipsis"> 3. Intended use </span> </a> </li> <li class="md-nav__item"> <a href="#4-intended-users" class="md-nav__link"> <span class="md-ellipsis"> 4. Intended users </span> </a> </li> <li class="md-nav__item"> <a href="#5-deployment-context" class="md-nav__link"> <span class="md-ellipsis"> 5. Deployment context </span> </a> </li> <li class="md-nav__item"> <a href="#6-explicitly-non-intended-uses" class="md-nav__link"> <span class="md-ellipsis"> 6. Explicitly NON-intended uses </span> </a> </li> <li class="md-nav__item"> <a href="#7-honest-status-notes-for-the-validation-record" class="md-nav__link"> <span class="md-ellipsis"> 7. Honest status notes (for the validation record) </span> </a> </li> <li class="md-nav__item"> <a href="#8-open-points-for-the-red-pen-round-template-level" class="md-nav__link"> <span class="md-ellipsis"> 8. Open points for the red-pen round (template-level) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item"> <a href="../tool-risk-assessment/" class="md-nav__link"> <span class="md-ellipsis"> Tool-Risk Assessment — LQMS as a QMS Tool (TEMPLATE) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_10" > <label class="md-nav__link" for="__nav_10" id="__nav_10_label" tabindex="0"> <span class="md-ellipsis"> Regulatory </span> <span class="md-nav__icon md-icon"></span> </label> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_10_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_10"> <span class="md-nav__icon md-icon"></span> Regulatory </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../../regulatory/mdr-annex-i-skeleton/" class="md-nav__link"> <span class="md-ellipsis"> MDR Annex I — GSPR authoring skeleton (paraphrased) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_11" > <div class="md-nav__link md-nav__container"> <a href="../../../user-guide/" class="md-nav__link "> <span class="md-ellipsis"> User guide </span> </a> <label class="md-nav__link " for="__nav_11" id="__nav_11_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_11_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_11"> <span class="md-nav__icon md-icon"></span> User guide </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../../user-guide/tutorial/" class="md-nav__link"> <span class="md-ellipsis"> Tutorial — from zero to a released document </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/administration/" class="md-nav__link"> <span class="md-ellipsis"> Administering an LQMS Installation </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/diagrams/" class="md-nav__link"> <span class="md-ellipsis"> Diagrams </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/documents-lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Documents & the Lifecycle </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/exports/" class="md-nav__link"> <span class="md-ellipsis"> PDF Exports & the Audit Pack </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/obligations/" class="md-nav__link"> <span class="md-ellipsis"> Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/project-context/" class="md-nav__link"> <span class="md-ellipsis"> The Project Context & App Version </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/review-comments/" class="md-nav__link"> <span class="md-ellipsis"> Review Comments </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/activity-trail/" class="md-nav__link"> <span class="md-ellipsis"> Who did what, when — reading a project's activity </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/admin-scopes/" class="md-nav__link"> <span class="md-ellipsis"> Renaming a project, and what can never change </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/authority-view/" class="md-nav__link"> <span class="md-ellipsis"> Who holds each function here, and what may it do </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/break-glass/" class="md-nav__link"> <span class="md-ellipsis"> The permission I need is held by a role I do not hold — what now? </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/coverage-and-chains/" class="md-nav__link"> <span class="md-ellipsis"> Coverage or chains? — which requirement view answers your question </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/credentials/" class="md-nav__link"> <span class="md-ellipsis"> Your password: changing it, resetting it — and why LQMS never sees it </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/emergency-cover/" class="md-nav__link"> <span class="md-ellipsis"> Who may cover for whom here — declaring emergency cover, and reading where the glass was broken </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/key-rules/" class="md-nav__link"> <span class="md-ellipsis"> Special elements: what a project declares, and when its names freeze </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/memberships/" class="md-nav__link"> <span class="md-ellipsis"> Belonging to an organization: invitations, acceptance, and what they change </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/provisioning-birth-path/" class="md-nav__link"> <span class="md-ellipsis"> How a new organization and project are born </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/review-policies/" class="md-nav__link"> <span class="md-ellipsis"> What a review policy controls, and what an empty grant means </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/setup-wizard-lanes/" class="md-nav__link"> <span class="md-ellipsis"> The setup wizard: the lanes, and what it writes </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/staffing-and-assignments/" class="md-nav__link"> <span class="md-ellipsis"> Staffing people into roles, and the accountable holder </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/topics/technical-dossier/" class="md-nav__link"> <span class="md-ellipsis"> How do I assemble a technical dossier? </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/trace-items/" class="md-nav__link"> <span class="md-ellipsis"> Trace Items — Requirements, Risks & Risk Controls </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/trace-links/" class="md-nav__link"> <span class="md-ellipsis"> Trace Links & the Suspect Cycle </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/traceability-workspace/" class="md-nav__link"> <span class="md-ellipsis"> The Traceability Workspace </span> </a> </li> <li class="md-nav__item"> <a href="../../../user-guide/training/" class="md-nav__link"> <span class="md-ellipsis"> Training & Acknowledgements </span> </a> </li> </ul> </nav> </li> </ul> </nav> </div> </div> </div> <div class="md-sidebar md-sidebar--secondary" data-md-component="sidebar" data-md-type="toc" > <div class="md-sidebar__scrollwrap"> <div class="md-sidebar__inner"> <nav class="md-nav md-nav--secondary" aria-label="Table of contents"> <label class="md-nav__title" for="__toc"> <span class="md-nav__icon md-icon"></span> Table of contents </label> <ul class="md-nav__list" data-md-component="toc" data-md-scrollfix> <li class="md-nav__item"> <a href="#1-purpose-and-regulatory-frame" class="md-nav__link"> <span class="md-ellipsis"> 1. Purpose and regulatory frame </span> </a> </li> <li class="md-nav__item"> <a href="#2-instantiation-fields" class="md-nav__link"> <span class="md-ellipsis"> 2. Instantiation fields </span> </a> </li> <li class="md-nav__item"> <a href="#3-intended-use" class="md-nav__link"> <span class="md-ellipsis"> 3. Intended use </span> </a> </li> <li class="md-nav__item"> <a href="#4-intended-users" class="md-nav__link"> <span class="md-ellipsis"> 4. Intended users </span> </a> </li> <li class="md-nav__item"> <a href="#5-deployment-context" class="md-nav__link"> <span class="md-ellipsis"> 5. Deployment context </span> </a> </li> <li class="md-nav__item"> <a href="#6-explicitly-non-intended-uses" class="md-nav__link"> <span class="md-ellipsis"> 6. Explicitly NON-intended uses </span> </a> </li> <li class="md-nav__item"> <a href="#7-honest-status-notes-for-the-validation-record" class="md-nav__link"> <span class="md-ellipsis"> 7. Honest status notes (for the validation record) </span> </a> </li> <li class="md-nav__item"> <a href="#8-open-points-for-the-red-pen-round-template-level" class="md-nav__link"> <span class="md-ellipsis"> 8. Open points for the red-pen round (template-level) </span> </a> </li> </ul> </nav> </div> </div> </div> <div class="md-content" data-md-component="content"> <article class="md-content__inner md-typeset"> <a href="https://github.com/nburri/lqms/edit/main/docs/validation/templates/intended-use.md" title="Edit this page" class="md-content__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M10 20H6V4h7v5h5v3.1l2-2V8l-6-6H6c-1.1 0-2 .9-2 2v16c0 1.1.9 2 2 2h4zm10.2-7c.1 0 .3.1.4.2l1.3 1.3c.2.2.2.6 0 .8l-1 1-2.1-2.1 1-1c.1-.1.2-.2.4-.2m0 3.9L14.1 23H12v-2.1l6.1-6.1z"/></svg> </a> <!-- REVIEWED — red-pen round CLOSED 2026-07-26. --> <blockquote> <p><strong>Review (2026-07-26):</strong> approved as the tool-lane template by <strong>Nicolas Burri</strong> (C-V2 red-pen round; QMS/engineering domain-expert review, no legal-counsel claim — legal review deferred to before any commercial distribution).</p> </blockquote> <h1 id="intended-use-specification--lqms-as-a-qms--document-control-tool-template">Intended-Use Specification — LQMS as a QMS / Document-Control Tool (TEMPLATE)<a class="headerlink" href="#intended-use-specification--lqms-as-a-qms--document-control-tool-template" title="Permanent link">¶</a></h1> <blockquote> <p><strong>Tool-lane TEMPLATE, free of any organisation's specifics.</strong> Per <a href="../../../decisions/adr-0061-csv-validation-package/">ADR-0061</a> §2 the intended-use specification ships as a <strong>seeded template document in LQMS itself</strong> (C-V2a); each organisation that uses LQMS in its quality management system instantiates it for its own use. The instantiation is <strong>organisation-specific by design</strong> (ADR-0061 §3) — this template is the skeleton it fills, not a substitute for it: what LQMS <em>is intended to be used for here</em> is a statement only the operating organisation can make. <strong>This document references no instance document</strong> — see the <a href="../../#the-rule">lane rule</a>.</p> <p><strong>Status:</strong> working draft for review, not yet a controlled document.</p> <p><strong>Norm handling:</strong> standards (ISO/IEC/EN) are paraphrased with clause citations only; no verbatim normative text (conventions.md; ADR-0061 D-5).</p> </blockquote> <h2 id="1-purpose-and-regulatory-frame">1. Purpose and regulatory frame<a class="headerlink" href="#1-purpose-and-regulatory-frame" title="Permanent link">¶</a></h2> <p>This document states what LQMS is <strong>intended to be used for</strong> at <strong>{{organisation}}</strong>, by whom, in what deployment context, and — as importantly — what it is <strong>not</strong> intended for. It is the intended-use input to the organisation's own tool validation.</p> <p>The applicable duty is ISO 13485 <strong>§4.1.6</strong>: the organisation that <em>uses</em> software in its quality management system validates that software for its intended use, proportionate to risk, before first use and after changes, and retains records (<strong>§4.2.5</strong>). This document supplies the "intended use" that the validation is measured against; the companion tool-risk assessment ({{riskAssessmentRef}}; skeleton: <a href="../tool-risk-assessment/">tool-risk-assessment.md</a>) supplies the "proportionate to risk" input, and the CSV package (ADR-0061: release-validation report, IQ checklist, PQ protocol) supplies the evidence.</p> <p>LQMS is <strong>not itself medical-device software</strong> and is not placed on any market as a device. It is a QMS / document-control tool. The validation vocabulary (intended use, IQ/OQ/PQ, tool-risk) is borrowed from GAMP-5 and the auditors' expectations, not because LQMS is a regulated product.</p> <h2 id="2-instantiation-fields">2. Instantiation fields<a class="headerlink" href="#2-instantiation-fields" title="Permanent link">¶</a></h2> <p>Mechanics (<code>template-vars</code> declarations + brace placeholders, camelCase keys): <a href="../../../decisions/adr-0049-content-model-round2/">ADR-0049</a> §2 and the <a href="../../#how-template-fields-work">field guide</a>.</p> <div class="highlight"><pre><span></span><code><a id="__codelineno-0-1" name="__codelineno-0-1" href="#__codelineno-0-1"></a>organisation | Organisation validating its use of LQMS | yes | <a id="__codelineno-0-2" name="__codelineno-0-2" href="#__codelineno-0-2"></a>instanceName | Deployment / instance identifier | yes | <a id="__codelineno-0-3" name="__codelineno-0-3" href="#__codelineno-0-3"></a>lqmsRelease | LQMS release in use (tag + git SHA) | yes | <a id="__codelineno-0-4" name="__codelineno-0-4" href="#__codelineno-0-4"></a>qmsScope | The QMS domain this instance governs — whose content it holds | yes | <a id="__codelineno-0-5" name="__codelineno-0-5" href="#__codelineno-0-5"></a>identityProvider | Identity provider authenticating the users | no | OIDC / Keycloak <a id="__codelineno-0-6" name="__codelineno-0-6" href="#__codelineno-0-6"></a>userScale | Expected scale (users, document versions) | no | ~100 users, low hundreds of thousands of versions <a id="__codelineno-0-7" name="__codelineno-0-7" href="#__codelineno-0-7"></a>riskAssessmentRef | Companion tool-risk assessment (document id) | yes | <a id="__codelineno-0-8" name="__codelineno-0-8" href="#__codelineno-0-8"></a>backupCadence | Backup + restore-rehearsal cadence on this deployment (automated / manual) | yes | <a id="__codelineno-0-9" name="__codelineno-0-9" href="#__codelineno-0-9"></a>hardeningStatus | Deployment hardening per the operations guide (applied / pending) | yes | <a id="__codelineno-0-10" name="__codelineno-0-10" href="#__codelineno-0-10"></a>esignatureStatus | Electronic-signature capability in this deployment (configured / not configured) | no | not configured <a id="__codelineno-0-11" name="__codelineno-0-11" href="#__codelineno-0-11"></a>emailDelivery | Email / notification delivery in this deployment (enabled / disabled) | no | disabled </code></pre></div> <p><strong>Instance identity:</strong> {{organisation}} · instance {{instanceName}} · LQMS {{lqmsRelease}} · scope of use: {{qmsScope}}.</p> <h2 id="3-intended-use">3. Intended use<a class="headerlink" href="#3-intended-use" title="Permanent link">¶</a></h2> <p>LQMS is intended to serve as {{organisation}}'s controlled-document and quality-records system for {{qmsScope}}. The intended functions, each already realised in the tool — <strong>the instantiation confirms which of them it relies on, and states any it deliberately does not use</strong>:</p> <ol> <li><strong>Document control.</strong> Authoring, review, approval, release, revision, effectivity and periodic review of controlled documents (SOPs, work instructions, templates, records). The life cycle is structural: a document is an ordered series of versions, each recording author, state and change description; release is gated by a configurable review policy (four-eyes by default). The canonical content record is the document tree, with markdown/PDF derived from it (ADR-0057); released content is frozen and the vehicle for change is a new version, not an in-place edit.</li> <li><strong>The correct version is served.</strong> The <em>currently effective</em> version is derived — the released, non-revoked version with the latest effective date not after now — never a stored, drift-prone flag (REQ-EFF-002; <a href="../../../decisions/adr-0015-effectivity-periodic-review/">ADR-0015</a>). Periodic review is flagged and escalated; the tool never silently revokes a governing document.</li> <li><strong>Training / read-acknowledgement.</strong> A released document that requires acknowledgement fans out one acknowledgement obligation per addressed person; the acknowledgement is a controlled, version-precise record; status is reportable per document / role / scope, gaps first (<a href="../../../decisions/adr-0022-training-management-scope/">ADR-0022</a>, <a href="../../../decisions/adr-0052-addressees-acknowledgement/">ADR-0052</a>/ <a href="../../../decisions/adr-0053-addressees-per-document/">ADR-0053</a>). Scope is read-and-acknowledge, not full training management.</li> <li><strong>Traceability.</strong> Keyed trace items (requirements, risks, risk-controls) and typed links (satisfies / verifies / mitigates / implemented-by / derives-from / references) with coverage and end-to-end chain views. All traceability status is <strong>derived live, never stored</strong> — the house doctrine — with per-hop suspect flags when an upstream item moves (<a href="../../../decisions/adr-0078-generalized-trace-items/">ADR-0078</a>, <a href="../../../decisions/adr-0079-risk-items/">ADR-0079</a>, <a href="../../../decisions/adr-0086-requirement-trace-chains/">ADR-0086</a>).</li> <li><strong>Exports and audit packs.</strong> Server-side PDF export of released documents over the one canonical render path, with a §4.2.4-style identity header and an honest "uncontrolled copy" distribution footer (<a href="../../../decisions/adr-0074-pdf-export/">ADR-0074</a>); scope audit packs and the traceability report as a zip of effective-released PDFs <strong>plus a hash manifest carrying a SHA-256 of every PDF</strong>, with transitive citation closure bounded by access rules (REQ-DOC-037; <a href="../../../decisions/adr-0083-td-dossier/">ADR-0083</a>).</li> <li><strong>Audit trail.</strong> Life-cycle and export events are recorded as an append-only audit trail tied to the acting identity.</li> </ol> <h2 id="4-intended-users">4. Intended users<a class="headerlink" href="#4-intended-users" title="Permanent link">¶</a></h2> <p>LQMS is operated by named people authenticated through the organisation's identity provider ({{identityProvider}}; <a href="../../../decisions/adr-0011-authentication-oidc-bff/">ADR-0011</a>/ <a href="../../../decisions/adr-0012-authorization-and-bootstrap/">ADR-0012</a>). Access is governed by roles granted per scope; the tool distinguishes <strong>workflow roles</strong> (who may act in the life cycle) from <strong>audience roles</strong> (who a document is addressed to). The intended user roles — the instantiation states who holds each:</p> <table> <thead> <tr> <th>User</th> <th>Intended role in LQMS</th> </tr> </thead> <tbody> <tr> <td><strong>QMB / Quality management</strong></td> <td>Owns the QMS structure: creates scopes, configures document types and review policies, manages users and training, reads coverage and acknowledgement status.</td> </tr> <tr> <td><strong>Authors</strong></td> <td>Create and edit drafts, author trace items and links, submit for review.</td> </tr> <tr> <td><strong>Reviewers / approvers</strong></td> <td>Review and approve/release under the applicable review policy (four-eyes: the releaser is not the author).</td> </tr> <tr> <td><strong>Addressees (document audience)</strong></td> <td>Read released documents addressed to their organisational role and record their acknowledgement.</td> </tr> <tr> <td><strong>Auditors</strong></td> <td>Read released documents, traceability and coverage, and pull audit packs / the traceability report as verifiable evidence bundles. (VIEW-bounded; export reflects exactly what the caller may see.)</td> </tr> <tr> <td><strong>System administrator</strong></td> <td>Deploys, bootstraps the first admin, operates backups and upgrades.</td> </tr> </tbody> </table> <h2 id="5-deployment-context">5. Deployment context<a class="headerlink" href="#5-deployment-context" title="Permanent link">¶</a></h2> <ul> <li><strong>Self-hosted, single-instance, single-node "small" tier.</strong> One deployment per organisation, sized for roughly {{userScale}}, business-hours availability, with backup/restore as the data-durability control (<a href="../../../decisions/adr-0018-nonfunctional-targets/">ADR-0018</a>).</li> <li><strong>Reference topology:</strong> the LQMS application (Quarkus fast-jar), PostgreSQL, and the identity provider, wired by the <code>deploy/</code> Docker Compose stack and self-bootstrapping on first boot. A real deployment hardens the demo defaults (credentials, TLS, the two-role database hardening) per <a href="../../../operations/deployment/"><code>docs/operations/deployment.md</code></a> — status on this deployment: {{hardeningStatus}}.</li> <li><strong>Data separation</strong> between mandators and projects is enforced in the database by row-level security, independent of application code (<a href="../../../decisions/adr-0009-rls-session-scope-context/">ADR-0009</a>/ <a href="../../../decisions/adr-0026-rls-connection-pool-safety/">ADR-0026</a>/ <a href="../../../decisions/adr-0027-rls-content-vs-control-plane/">ADR-0027</a>).</li> <li><strong>Data durability</strong> is the scripted ordered backup with restore-rehearsal verification writing dated records (<a href="../../../decisions/adr-0060-backup-restore-mechanism/">ADR-0060</a>; RPO ≤ 24 h / RTO ≤ 1 business day per ADR-0018). Cadence on this deployment: {{backupCadence}} — <em>see §7; a manual cadence is an honest status note, not a silent assumption.</em></li> <li><strong>Operating environment:</strong> a current evergreen browser over the network; the deployment is responsible for TLS termination. Email/notification delivery is {{emailDelivery}} (<a href="../../../decisions/adr-0041-email-channel-and-notification-i18n/">ADR-0041</a> — disabled by default).</li> </ul> <h2 id="6-explicitly-non-intended-uses">6. Explicitly NON-intended uses<a class="headerlink" href="#6-explicitly-non-intended-uses" title="Permanent link">¶</a></h2> <p>Stated so the validation scope is bounded and the tool is not relied on beyond what it does today.</p> <p><strong>Tool-level exclusions — true of every installation at this release:</strong></p> <ol> <li><strong>Not a product-development ALM (yet).</strong> The product-development / regulatory-conformity axes (design-history / GSPR-style conformity views, the full application-lifecycle-management arc) are <strong>designed but not shipped</strong> — <a href="../../../decisions/adr-0084-validation-regulatory-axes/">ADR-0084</a> is <strong>proposed, not accepted</strong>. LQMS is not intended to be the ALM of record for a medical-device development until that arc lands and is validated.</li> <li><strong>No electronic-signature / 21 CFR Part 11 or Annex 11 claim unless configured and claimed.</strong> LQMS is <em>designed to be</em> Part 11 / Annex 11 <strong>capable</strong>, configurable per deployment (<a href="../../../decisions/adr-0014-electronic-signatures/">ADR-0014</a>, accepted at the design level; the REQ-SIG requirements are pending the next baseline). Signing status on this deployment: {{esignatureStatus}}. Where it is <strong>not configured</strong>, releases are plain four-eyes approvals — audited and identity-bound, but <strong>not asserted to be Part 11 electronic signatures</strong>; an LQMS approval must not be represented as a compliant e-signature until the signing capability is configured, validated and claimed.</li> <li><strong>Not a validated medical device or MDSW.</strong> LQMS is a software tool used in a QMS; it is not itself a medical device and carries no device conformity claim.</li> <li><strong>Not a high-availability / zero-RPO system.</strong> Single-node, business-hours, backup-based recovery (up to ~24 h of data at risk between backups). Not intended for continuous-availability or real-time-critical use.</li> <li><strong>Not a notification / messaging platform.</strong> Where email is disabled, obligations (reviews, acknowledgements, periodic reviews) surface <em>in the tool</em>; the deployment does not push external notifications.</li> </ol> <p><strong>Instance-specific exclusions — the instantiation states its own</strong>, at least: whose controlled records this instance does <strong>not</strong> hold (it is the operating organisation's own QMS unless declared otherwise — mandator separation is a separation control, not an offer to host third parties' records), and which domains, projects or document classes are deliberately kept outside it.</p> <h2 id="7-honest-status-notes-for-the-validation-record">7. Honest status notes (for the validation record)<a class="headerlink" href="#7-honest-status-notes-for-the-validation-record" title="Permanent link">¶</a></h2> <p>An intended-use specification must not imply a control that is not yet operating. The instantiation records the honest status of each field-driven item, at least:</p> <ul> <li><strong>Backup cadence ({{backupCadence}}):</strong> where the cadence is manual, say so — the mechanism is implemented and restore-verified, but continued execution depends on operator discipline, which is a residual operational risk (tool-risk assessment TR-003). Automating the cadence — a natural first <a href="../../../decisions/adr-0089-recurring-obligations/">ADR-0089</a> recurring obligation — is the closing act before relying on LQMS for retained records at §4.2.5 scale.</li> <li><strong>E-signatures ({{esignatureStatus}}):</strong> capability designed; state whether it is enabled here — see §6.2.</li> <li><strong>Deployment hardening ({{hardeningStatus}}):</strong> state whether the production hardening is applied; several mitigations in the companion risk assessment depend on it.</li> <li><strong>Conformity / ALM axes:</strong> ADR-0084 proposed — see §6.1.</li> </ul> <h2 id="8-open-points-for-the-red-pen-round-template-level">8. Open points for the red-pen round (template-level)<a class="headerlink" href="#8-open-points-for-the-red-pen-round-template-level" title="Permanent link">¶</a></h2> <ul> <li><strong>Does this template earn its keep?</strong> The intended-use <em>instantiation</em> is organisation-specific by design (ADR-0061 §3), so this skeleton carries the parts that recur: the §4.1.6 frame, the function inventory, the role model, the deployment context and the tool-level exclusions. Judgement made: it is <strong>not</strong> artificial — those five parts are identical for every customer, and the alternative is each customer re-deriving them from the ADRs. Confirm, or fold the skeleton into the risk template and let intended use stay purely per-organisation.</li> <li><strong>Duplication with the instantiation is deliberate.</strong> Unlike the risk assessment (where the instance is a thin record of judgments over the template's rows), an intended-use instantiation reads as a standalone specification, so it restates §3–§6 in its own voice with its own selections. That is how template instantiation works in the tool (the instantiated body <em>is</em> the template body with the values substituted) — it is not drift. Confirm you want it that way here.</li> <li><strong>The function inventory doubles as a capability list.</strong> §3 states what the tool does, which makes it useful but also makes it a maintenance point at every release. Alternative: reference the requirements baseline instead of restating functions. Restating was chosen because an auditor reads intended use standalone.</li> <li><strong><code>userScale</code> as a field</strong> parameterises the ADR-0018 "small tier" numbers. 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