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Evaluate LQMS
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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--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_9" > <div class="md-nav__link md-nav__container"> <a href="../../validation/" 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="false"> <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="../../validation/templates/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"> <a href="../../validation/templates/intended-use/" class="md-nav__link"> <span class="md-ellipsis"> Intended-Use Specification — LQMS as a QMS / Document-Control Tool (TEMPLATE) </span> </a> </li> <li class="md-nav__item"> <a href="../../validation/templates/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--active md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_11" checked> <div class="md-nav__link md-nav__container"> <a href="../" 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="true"> <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="../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="../administration/" class="md-nav__link"> <span class="md-ellipsis"> Administering an LQMS Installation </span> </a> </li> <li class="md-nav__item"> <a href="../diagrams/" class="md-nav__link"> <span class="md-ellipsis"> Diagrams </span> </a> </li> <li class="md-nav__item"> <a href="../documents-lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Documents & the Lifecycle </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"> PDF Exports & the Audit Pack </span> <span class="md-nav__icon md-icon"></span> </label> <a href="./" class="md-nav__link md-nav__link--active"> <span class="md-ellipsis"> PDF Exports & the Audit Pack </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-the-export-menu--and-which-shape-to-pick" class="md-nav__link"> <span class="md-ellipsis"> 1. The export menu — and which shape to pick </span> </a> </li> <li class="md-nav__item"> <a href="#2-why-the-zip-warns-about-acrobat" class="md-nav__link"> <span class="md-ellipsis"> 2. Why the zip warns about Acrobat </span> </a> </li> <li class="md-nav__item"> <a href="#3-what-is-inside-the-zip" class="md-nav__link"> <span class="md-ellipsis"> 3. What is inside the zip </span> </a> </li> <li class="md-nav__item"> <a href="#4-risk-content-in-the-pdf" class="md-nav__link"> <span class="md-ellipsis"> 4. Risk content in the PDF </span> </a> </li> <li class="md-nav__item"> <a href="#5-the-derived-traceability-annex" class="md-nav__link"> <span class="md-ellipsis"> 5. The derived-traceability annex </span> </a> </li> <li class="md-nav__item"> <a href="#6-the-scope-traceability-report" class="md-nav__link"> <span class="md-ellipsis"> 6. The scope traceability report </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item"> <a href="../obligations/" class="md-nav__link"> <span class="md-ellipsis"> Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../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="../review-comments/" class="md-nav__link"> <span class="md-ellipsis"> Review Comments </span> </a> </li> <li class="md-nav__item"> <a href="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../traceability-workspace/" class="md-nav__link"> <span class="md-ellipsis"> The Traceability Workspace </span> </a> </li> <li class="md-nav__item"> <a href="../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-the-export-menu--and-which-shape-to-pick" class="md-nav__link"> <span class="md-ellipsis"> 1. The export menu — and which shape to pick </span> </a> </li> <li class="md-nav__item"> <a href="#2-why-the-zip-warns-about-acrobat" class="md-nav__link"> <span class="md-ellipsis"> 2. Why the zip warns about Acrobat </span> </a> </li> <li class="md-nav__item"> <a href="#3-what-is-inside-the-zip" class="md-nav__link"> <span class="md-ellipsis"> 3. What is inside the zip </span> </a> </li> <li class="md-nav__item"> <a href="#4-risk-content-in-the-pdf" class="md-nav__link"> <span class="md-ellipsis"> 4. Risk content in the PDF </span> </a> </li> <li class="md-nav__item"> <a href="#5-the-derived-traceability-annex" class="md-nav__link"> <span class="md-ellipsis"> 5. The derived-traceability annex </span> </a> </li> <li class="md-nav__item"> <a href="#6-the-scope-traceability-report" class="md-nav__link"> <span class="md-ellipsis"> 6. The scope traceability report </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/user-guide/exports.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> <h1 id="pdf-exports--the-audit-pack">PDF Exports & the Audit Pack<a class="headerlink" href="#pdf-exports--the-audit-pack" title="Permanent link">¶</a></h1> <p><em>Audience: quality managers, and anyone preparing copies for an audit or a notified body.</em></p> <p>LQMS renders controlled documents to PDF <strong>server-side</strong> — the same for everyone, recorded as an audit event, and stamped as an uncontrolled copy. The basics of a <strong>single document's</strong> PDF (the <em>Download PDF</em> action, exportable states, the per-page <em>uncontrolled copy</em> band, the honest degradations of Mermaid/math/<code>doc:</code> links) are covered in <a href="../documents-lifecycle/">Documents & the lifecycle</a> §8. This chapter covers what comes <em>after</em> the single document: the <strong>scope audit pack</strong> (a whole scope at once, in two shapes), how risk content prints, and the <strong>derived-traceability annex</strong>.</p> <blockquote> <p><strong>Judgment note.</strong> This is a new chapter rather than an extension of documents-lifecycle §8: the single-document PDF is one action on one version, while the audit pack, the merged/zip choice, and the traceability annex are their own subject with their own audience (audit preparation). §1 below deliberately points back to §8 for the single-PDF fundamentals rather than repeating them.</p> </blockquote> <h2 id="1-the-export-menu--and-which-shape-to-pick">1. The export menu — and which shape to pick<a class="headerlink" href="#1-the-export-menu--and-which-shape-to-pick" title="Permanent link">¶</a></h2> <p>On the documents view, the actions menu (⋮) offers the scope-level pack in two shapes. The order is deliberate:</p> <ul> <li><strong>Audit pack (single PDF)</strong> — <em>leads the menu.</em> One merged PDF: a cover, a clickable table of contents, then each document as a chapter with its own bookmark subtree and continuous page numbering. <strong>Its internal links work in every PDF viewer</strong> — that is why it leads. This is the reviewer's copy.</li> <li><strong>Audit pack (zip)</strong> — a zip with one PDF per document, plus manifests (§3). It carries a caution line: <em>"Cross-document links open only in Adobe Acrobat."</em></li> </ul> <p>Both render every currently-effective <strong>released</strong> version the caller can see in the scope, through the <em>same</em> PDF path as a single document (same identity header, same per-page uncontrolled-copy band, same audit event). They are <strong>separate artifacts</strong> — you get the zip <em>or</em> the merged PDF, never both bundled together. A spinner shows while a pack is being prepared, and the download starts automatically when it is ready.</p> <blockquote> <p><strong>The pack's curated sibling.</strong> An audit pack answers <em>"what is in this project right now?"</em> — it is always the currently-effective set, and it is regenerated fresh on every export. It cannot answer <em>"what is the technical file for device X?"</em>, which needs <strong>chosen versions</strong>, arranged under a <strong>regulatory skeleton</strong>, and <strong>frozen</strong> at a point in time. That is a <strong>technical dossier</strong>, and it is a separate object with its own surface, its own DRAFT → ISSUED lifecycle, and the same two export shapes as this pack. See <a href="../topics/technical-dossier/">How do I assemble a technical dossier?</a>.</p> <p><strong>Citation closure.</strong> By default a pack also pulls in the documents your scope's documents <em>cite</em> — governing procedures in another scope, for instance — each at its effective released version, as long as you are allowed to see them. The claim of a pack is "what the auditor needs for this scope", and a cited document the auditor cannot open would be the surprising omission.</p> </blockquote> <h2 id="2-why-the-zip-warns-about-acrobat">2. Why the zip warns about Acrobat<a class="headerlink" href="#2-why-the-zip-warns-about-acrobat" title="Permanent link">¶</a></h2> <p>In the <strong>merged</strong> PDF, a link from one document to another is an <em>internal</em> jump within the single file, so it resolves in any viewer. In the <strong>zip</strong>, a link from one PDF to a <em>sibling</em> PDF is a cross-file ("remote go-to") link — and following those needs a viewer that supports them: <strong>Adobe Acrobat Reader and most full PDF viewers do; macOS Preview does not.</strong> (It was byte-verified that Preview simply ignores such links.) Keep the zip's files together in one folder so the links can resolve, or — for navigation that works anywhere — use the merged single PDF instead. The zip's own <strong>README.txt</strong> says exactly this.</p> <h2 id="3-what-is-inside-the-zip">3. What is inside the zip<a class="headerlink" href="#3-what-is-inside-the-zip" title="Permanent link">¶</a></h2> <p>The zip holds, at its root:</p> <ul> <li><strong>One PDF per document</strong> — the currently-effective released version, named by human id and version.</li> <li><strong>traceability-report.pdf</strong> — the scope's derived traceability report (§6), placed before the manifests and listed + SHA-256-hashed in the manifest like every other entry. Present <strong>only when you hold <code>VIEW_TRACEABILITY</code></strong> in the scope.</li> <li><strong>README.txt</strong> — a plain-language orientation: what the pack is, the cross-file-link viewer reality above, and the completeness rule below. It is written first so it stays useful even if a download is cut short.</li> <li><strong>manifest.json</strong> and <strong>manifest.txt</strong> — describing the set and carrying a <strong>SHA-256</strong> of each PDF, so the bundle is verifiable evidence-grade.</li> </ul> <p><strong>The completeness marker.</strong> <code>manifest.txt</code> is written <strong>last</strong>. So the rule is simple: <em>if <code>manifest.txt</code> is present and the archive opens as a valid zip, the pack is complete</em>; if it is missing, the download was truncated and you should re-export. A truncated pack is detectably incomplete rather than silently short.</p> <h2 id="4-risk-content-in-the-pdf">4. Risk content in the PDF<a class="headerlink" href="#4-risk-content-in-the-pdf" title="Permanent link">¶</a></h2> <p>A risk-analysis document's <code>:::risk</code> and <code>:::risk-control</code> blocks render in the PDF as formatted blocks — key, labelled attributes, and body — not as raw fence text. Scores print as the recorded tokens (e.g. <code>S3 · P1 · P2 — High</code>), never as a computed equation, exactly as on screen (see <a href="../trace-items/">trace-items</a> §4). This is the released risk table an auditor reads in the controlled copy.</p> <h2 id="5-the-derived-traceability-annex">5. The derived-traceability annex<a class="headerlink" href="#5-the-derived-traceability-annex" title="Permanent link">¶</a></h2> <p>The frozen document content shows the risk/control <em>content</em> — but a control's <em>implementation</em> and <em>verification</em> are <strong>links</strong>, not document content, and so are honestly absent from the frozen record. To close that gap without blurring the boundary, a PDF export of any version that <strong>defines risk or risk-control items</strong> carries a clearly-bounded <strong>annex after the document content</strong>:</p> <blockquote> <p><strong>Derived traceability — as at export</strong> <em>(not part of the controlled content)</em></p> </blockquote> <p>The annex has, in content order:</p> <ul> <li><strong>Risks</strong> — one row per risk defined in the document: <strong>Key | Mitigated by | Gaps</strong>. <em>Mitigated by</em> names the control keys (with the defining document's id when a control lives elsewhere); <em>Gaps</em> carries the derived risk-level flags — with the accepted-without-reduction semantics intact (an acceptable initial risk with no control and no residual is complete, so it shows no flag).</li> <li><strong>Controls</strong> — one row per control defined in the document: <strong>Key | Mitigates | Implemented by | Verified by | Gaps</strong>.</li> </ul> <p>When a document defines both, both sections appear (risks first). A document defining no risk items gets <strong>no annex</strong> — there is no empty scaffolding.</p> <p>Three things make the annex honest:</p> <ul> <li><strong>"As at export".</strong> Unlike the frozen content, the annex is derived <strong>live at the export moment</strong>. The same version exported on two days may carry a different annex if links changed between — that is by design, and the label says so. The annex is never part of the document's content hash.</li> <li><strong>Visually separate and labelled</strong>, so an auditor can never mistake link-derived rows for reviewed content.</li> <li><strong>Permission-conditional.</strong> The annex derives from the same data the traceability views show, so it is included <strong>only when the exporter holds <code>VIEW_TRACEABILITY</code></strong> in the scope. Without that permission the PDF renders <strong>without</strong> the annex — no placeholder, no error. The annex must never become a backdoor around the per-view gating (see <a href="../traceability-workspace/">traceability-workspace</a> §1). This is why an export may legitimately <em>lack</em> the annex: either the document defines no risk items, or the exporter lacks <code>VIEW_TRACEABILITY</code>.</li> </ul> <p>The annex appears in all export shapes — the single-document PDF, each zip pack entry, and each merged chapter.</p> <h2 id="6-the-scope-traceability-report">6. The scope traceability report<a class="headerlink" href="#6-the-scope-traceability-report" title="Permanent link">¶</a></h2> <p>Distinct from the per-document annex above, the <strong>scope traceability report</strong> is a whole-scope artifact: one derived PDF compiling the scope's entire traceability picture — a front-page <strong>gap digest</strong> (unsatisfied/unverified requirements, the risk gap counts, coverage-rule gaps, suspect links), then sectioned detail tables for the requirement chains, the requirement-verification status of each software requirement (its evidence class — unverified / planned only / verified), the risk chains, and the document-relation coverage. It is generated <strong>live from the same read models</strong> the traceability workspace views show — nothing is stored — so it can never disagree with the on-screen views or the requirement-chains CSV. You download it from the <strong>Traceability workspace</strong> hub (see <a href="../traceability-workspace/">traceability-workspace</a> §1) via its <strong>Traceability report (PDF)</strong> action; it is <code>VIEW_TRACEABILITY</code>-gated and carries the same honesty chrome as every export — the <em>"derived — as at export"</em> heading and the uncontrolled-copy band, with the explicit statement that it is not controlled content.</p> <p><strong>In the audit pack.</strong> The report also rides in the scope audit pack: in the <strong>zip</strong> as <code>traceability-report.pdf</code> (listed and hashed in the manifest like every other entry, §3), and in the <strong>merged</strong> single PDF as a closing chapter. Its inclusion is <strong>permission-conditional</strong> — the pack carries the report <strong>only when the exporter holds <code>VIEW_TRACEABILITY</code></strong> in the scope, exactly the rule the per-document annex follows (§5). The pack must never become a backdoor around the per-view gating.</p> <p><strong>Milestone snapshots.</strong> To freeze the traceability state at a milestone — a design review, a release gate — export the report and <strong>attach it to the review record</strong> as a file attachment (the Attachments section, see <a href="../documents-lifecycle/">documents-lifecycle</a> §2). That gives you a reviewed, frozen snapshot <em>as a record</em>, without the tool pretending derived data is controlled content. There is deliberately no separate "snapshot" entity — the record + file-attachment machinery already does it.</p> <hr /> <p><em>Governing decisions: ADR-0074 (server-side PDF, uncontrolled-copy band, honest degradations, the merged-pack render path, and the 2026-07-20 derived-traceability-annex clarification — risk + control rows, "as at export" boundary, VIEW_TRACEABILITY condition), ADR-0083 (the audit pack — zip with hash manifest + the merged reviewer's copy, ADR-0060 §5 packaging — and the technical dossier, the curated deliverable this pack is the uncurated counterpart of), ADR-0087 (the scope traceability report — one derived PDF over the read models, the hub download + the permission-conditional audit-pack entry, milestone snapshots via attach-to-record), ADR-0079/0082 (the risk content the annex derives from), ADR-0069 (file attachments — the milestone-snapshot vehicle). 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