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ADR-0083: The TD Dossier — a Versioned, Cross-Scope, Regulatory-Structured Deliverable
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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-0083: The TD Dossier — a Versioned, Cross-Scope, Regulatory-Structured Deliverable
Table of contents
Context
Decisions (D-1..D-7, all as recommended)
Non-goals
Consequences
Realization note (3a, 2026-08-04/05)
Clarification 2026-08-05 — a DRAFT dossier DOES export the merged PDF, watermarked
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--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_11" > <div class="md-nav__link md-nav__container"> <a 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</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="#context" class="md-nav__link"> <span class="md-ellipsis"> Context </span> </a> </li> <li class="md-nav__item"> <a href="#decisions-d-1d-7-all-as-recommended" class="md-nav__link"> <span class="md-ellipsis"> Decisions (D-1..D-7, all as recommended) </span> </a> </li> <li class="md-nav__item"> <a href="#non-goals" class="md-nav__link"> <span class="md-ellipsis"> Non-goals </span> </a> </li> <li class="md-nav__item"> <a href="#consequences" class="md-nav__link"> <span class="md-ellipsis"> Consequences </span> </a> </li> <li class="md-nav__item"> <a href="#realization-note-3a-2026-08-0405" class="md-nav__link"> <span class="md-ellipsis"> Realization note (3a, 2026-08-04/05) </span> </a> </li> <li class="md-nav__item"> <a href="#clarification-2026-08-05--a-draft-dossier-does-export-the-merged-pdf-watermarked" class="md-nav__link"> <span class="md-ellipsis"> Clarification 2026-08-05 — a DRAFT dossier DOES export the merged PDF, watermarked </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/decisions/adr-0083-td-dossier.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="adr-0083-the-td-dossier--a-versioned-cross-scope-regulatory-structured-deliverable">ADR-0083: The TD Dossier — a Versioned, Cross-Scope, Regulatory-Structured Deliverable<a class="headerlink" href="#adr-0083-the-td-dossier--a-versioned-cross-scope-regulatory-structured-deliverable" title="Permanent link">¶</a></h1> <ul> <li><strong>Status:</strong> accepted (Nicolas 2026-07-19 — all seven recommendations of <code>docs/ai/td-dossier-options.md</code> confirmed as D-1..D-7; that paper is this ADR's decision basis and evidence record).</li> <li><strong>Date:</strong> 2026-07-19</li> <li><strong>Deciders:</strong> Nicolas Burri, design by Claude.</li> <li><strong>Builds on:</strong> ADR-0074 (PDF render path — the only render surface), ADR-0075 (claims record / version continuity), ADR-0021/0049 (version-precise pins, coverage-style completeness), ADR-0060 §5 (audit pack), the suspect pattern (ADR-0077 stage 2 / ADR-0081 family), <code>docs/planning/deliverable-structures.md</code> (D-A), <code>docs/planning/traceability-model.md</code> §5 (the baseline property this realizes).</li> <li><strong>Refined by:</strong> <a href="../adr-0104-dossier-artifact-of-record/">ADR-0104</a> (the on-the-fly render for ISSUED dossiers is superseded — an issued dossier is a <strong>persisted artifact of record</strong>, its stored bytes and stable hash are its identity, plain delete is forbidden, and re-issue clones to a new draft)</li> </ul> <h2 id="context">Context<a class="headerlink" href="#context" title="Permanent link">¶</a></h2> <p>Auditors and notified bodies receive a <em>curated, version-pinned, regulatory-structured PDF set</em> — not a live database (options paper §4: Matrix, Greenlight, IMDRF practice). The scope audit pack ("everything in this scope, now") is nearly free but does not answer "the technical file for device X". The dossier is that answer: chosen versions, arranged under a regulatory skeleton, frozen as an issued baseline. The motivating cross-scope case is live in the data: PULSEMED documents cite governing MeridianQMS procedures.</p> <h2 id="decisions-d-1d-7-all-as-recommended">Decisions (D-1..D-7, all as recommended)<a class="headerlink" href="#decisions-d-1d-7-all-as-recommended" title="Permanent link">¶</a></h2> <ol> <li><strong>D-1 — Build the dossier (3a); ship the scope audit pack first</strong> (~0.5 slice, ADR-0060 §5 packaging over ADR-0074 PDFs + manifest). The dossier realizes the traceability model's baseline/snapshot property.</li> <li><strong>D-2 — Pins are DOCUMENT VERSIONS</strong>, modeled as an extensible content-reference: <code>SectionPin { kind: DOCUMENT; documentId, versionId }</code> with the seam for future <code>ITEM</code> / <code>ITEM_GLOB</code> kinds. Note recorded at acceptance: the requirement-item substrate now EXISTS (ADR-0077/-0078/-0079), so the seam is cheap to open later — but the <em>deliverable</em> NBs receive is document-level, and item-level trace is already served by the traceability views. Full-ALM (option iii) stays out.</li> <li><strong>D-3 — Skeletons at ship: MDR Annex II, IEC 62304 software file, custom.</strong> Fixed catalog templates authored from the <code>norms/</code> texts (paraphrased per ADR-0061 D-5); 62304 Class B/C mandatory-slot toggles are template attributes, not code. IMDRF nIVD deferred until a submission customer appears. The Annex II §4 GSPR slot can later feed from Stage C <code>regulatory-ref</code> items without remodeling.</li> <li><strong>D-4 — Export shape: BOTH</strong> — one merged PDF (cover + ToC + sections, the reviewer's copy) AND a zip of per-document PDFs with a hash MANIFEST always (the evidence-grade, verifiable bundle). Single render path: ADR-0074's markdown→FO→FOP over N pinned versions; same footer band, same <code>EXPORTED</code> audit, same honest degradations.</li> <li><strong>D-5 — The suspect flag ships with 3a</strong>: a DRAFT dossier section whose pinned version has been superseded shows a live read-time verdict (pinned version-id vs the document's current effective version-id — one query, no stored state). The <strong>audited re-pin action</strong> and <strong>re-issue as a new dossier version</strong> (ADR-0075 continuity) are slice <strong>3b</strong>. An ISSUED dossier is immutable; advancing is always a new dossier version.</li> <li><strong>D-6 — Folder convention packs (D-B) remain authoring organization</strong>; the dossier is the issued deliverable. The folder tree must never pretend to be a dossier.</li> <li><strong>D-7 — This ADR</strong> is that required record; the dossier entity (name, skeleton, sections with clause refs, filled-by hints, per-section notes, pinned content, DRAFT→ISSUED lifecycle) is a new first-class object; cross-scope pinning is RLS-governed (you pin only what you can see, ADR-0021 rule); completeness ("every mandatory slot has ≥1 released pin") is the coverage-rule-style live evaluator pointed at skeleton slots.</li> </ol> <h2 id="non-goals">Non-goals<a class="headerlink" href="#non-goals" title="Permanent link">¶</a></h2> <p>Item/glob pins (seam only, D-2); any second render surface (ADR-0074 is the path); folder-pack conflation (D-6); IMDRF skeleton (deferred); item-level trace inside the dossier (lives in the traceability workspace).</p> <h2 id="consequences">Consequences<a class="headerlink" href="#consequences" title="Permanent link">¶</a></h2> <ul> <li>Effort: 3a + the suspect flag ≈ 3–4 slices; 3b ≈ 1 slice. Sequencing: after the risk-table work and the expert/colleague conversations by default — pulled earlier only if a demo needs an issued dossier.</li> <li>Activates the traceability model's Stage D baseline thread; the change-impact/orphan surfaces remain separate Stage D work.</li> <li>The dossier entity, sections and pins are control/content-plane modeling decisions for the implementing wave to place per ADR-0027's boundary (pins reference cross-scope content — the read path must degrade per the inert-reference pattern, never leak).</li> </ul> <h2 id="realization-note-3a-2026-08-0405">Realization note (3a, 2026-08-04/05)<a class="headerlink" href="#realization-note-3a-2026-08-0405" title="Permanent link">¶</a></h2> <ul> <li><strong>Gate: a dedicated <code>MANAGE_DOSSIERS</code> permission</strong> (this ADR left the gate open). Confirmed by Nicolas 2026-08-05 ("I'd also keep the dedicated permission"). One write authority for every dossier act (create/edit/section/pin/issue/delete) per the ADR-0097 one-permission posture; deliberately NOT reused <code>CONFIGURE_REVIEW_POLICY</code> — issuing a submission baseline and rewriting review policies are separately grantable. Reads gated by VIEW + RLS. Narrow backfill over <code>CONFIGURE_REVIEW_POLICY</code> holders + bootstrap + seed parity.</li> <li><strong>Nav (open for Nicolas):</strong> "Dossiers" shipped as a 7<sup>th</sup> top-level nav word (both languages), a first-class deliverable per D-6. It pushes the toolbar collapse ceiling past 1280 (EN 1280 / DE 1440 now collapse into the overflow menu — inherent: 7 words cannot fit 1280 at any label length), re-measured per the 2026-07-29 collapse-when-can't-fit policy. Reversible levers if rejected: a documents-area door, or dropping another top-level word.</li> <li><strong>3a scope realized; deferred to 3b/later:</strong> re-pin + re-issue-as-new-version (schema admits it, no 3a path writes a 2<sup>nd</sup> version), ITEM/ITEM_GLOB pin kinds (CHECK seam only), pin reorder as a dedicated act, the IMDRF nIVD skeleton, per-dossier 62304 safety-class selector.</li> </ul> <h2 id="clarification-2026-08-05--a-draft-dossier-does-export-the-merged-pdf-watermarked">Clarification 2026-08-05 — a DRAFT dossier DOES export the merged PDF, watermarked<a class="headerlink" href="#clarification-2026-08-05--a-draft-dossier-does-export-the-merged-pdf-watermarked" title="Permanent link">¶</a></h2> <p>3a implemented "only an ISSUED dossier exports" for <strong>both</strong> bundles. Nicolas's first hands-on (register <code>feedback-2026-08-05-dossier.md</code> #2) asked for the draft PDF: a curator has to read the assembly as a reviewer will, and being unable to until they issue inverts the point of a draft. Amended as follows — the refusal is <strong>split by bundle</strong>, not lifted:</p> <ul> <li><strong>The merged PDF exports a DRAFT.</strong> It is regenerated on the fly, carries <strong>no hash</strong>, states on its cover that it is an uncontrolled review copy and not the record, is named <code>…_draft_….pdf</code>, and is stamped <strong><code>DRAFT</code> diagonally across every page</strong>. Its <code>EXPORTED</code> audit event carries <code>dossierState: DRAFT</code> beside the artifact <code>format</code>.</li> <li><strong>The zip stays ISSUED-only.</strong> It is the evidence-grade bundle: per-version PDFs with a SHA-256 manifest. A verifiable claim over contents that can still change is a false claim, and no watermark fixes that — the original D-4 reasoning applies to this bundle unchanged.</li> <li><strong>The draft copy renders the work-in-progress honestly</strong>, deliberately unsoftened: unfilled mandatory slots keep their section cards, superseded and unreachable pins keep their notices, and the cover keeps its incompleteness counts. The same renderers as the issued copy.</li> <li><strong>The invariant that replaces the refusal: watermark present ⟺ NOT the record.</strong> An issued dossier's PDF is unwatermarked — today still rendered on the fly, and under ADR-0104 it becomes the bytes stored at issue; either way the ABSENCE of the mark is what identifies the artifact of record. The watermark mechanism is a parameterized, non-dossier-specific facility of the ADR-0074 renderer (<code>PdfRenderer</code>), so any future not-the-record rendering marks itself the same way.</li> </ul> <p>The original reasoning ("a controlled-looking technical file whose contents can still change") was right about the RISK and wrong about the remedy: the risk is a draft copy circulating as if it were the deliverable, and a copy that says DRAFT on every page cannot. Refusing the render also had a cost the ADR did not weigh — it pushed a curator toward issuing a dossier merely to read it, which manufactures exactly the junk issued baselines that ADR-0104 §3 then forbids deleting.</p> </article> </div> <script>var target=document.getElementById(location.hash.slice(1));target&&target.name&&(target.checked=target.name.startsWith("__tabbed_"))</script> </div> <button type="button" class="md-top md-icon" data-md-component="top" hidden> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M13 20h-2V8l-5.5 5.5-1.42-1.42L12 4.16l7.92 7.92-1.42 1.42L13 8z"/></svg> Back to top </button> </main> <footer class="md-footer"> <nav class="md-footer__inner md-grid" aria-label="Footer" > <a href="../adr-0082-table-shaped-risk-authoring/" class="md-footer__link md-footer__link--prev" aria-label="Previous: ADR-0082: Table-Shaped Risk Authoring over Risk Blocks"> <div class="md-footer__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M20 11v2H8l5.5 5.5-1.42 1.42L4.16 12l7.92-7.92L13.5 5.5 8 11z"/></svg> </div> <div class="md-footer__title"> <span class="md-footer__direction"> Previous </span> <div class="md-ellipsis"> ADR-0082: Table-Shaped Risk Authoring over Risk Blocks </div> </div> </a> <a href="../adr-0084-validation-regulatory-axes/" class="md-footer__link md-footer__link--next" aria-label="Next: ADR-0084: Validation & Regulatory Axes (Traceability Model — Stage C)"> <div class="md-footer__title"> <span class="md-footer__direction"> Next </span> <div class="md-ellipsis"> ADR-0084: Validation & Regulatory Axes (Traceability Model — Stage C) </div> </div> <div class="md-footer__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M4 11v2h12l-5.5 5.5 1.42 1.42L19.84 12l-7.92-7.92L10.5 5.5 16 11z"/></svg> </div> </a> </nav> <div class="md-footer-meta md-typeset"> <div class="md-footer-meta__inner md-grid"> <div class="md-copyright"> <div class="md-copyright__highlight"> Built from <code>v0.9.56-4-g06c7f811</code> (commit <code>06c7f811</code>, 2026-09-09) — the same Markdown the repository ships. </div> </div> </div> </div> </footer> </div> <div class="md-dialog" data-md-component="dialog"> <div class="md-dialog__inner md-typeset"></div> </div> <script id="__config" type="application/json">{"base": "../..", "features": ["navigation.instant", "navigation.tracking", "navigation.top", "navigation.footer", "navigation.indexes", "toc.follow", "search.suggest", "search.highlight", "content.code.copy", "content.action.edit"], "search": "../../assets/javascripts/workers/search.6ce7567c.min.js", "translations": {"clipboard.copied": "Copied to clipboard", "clipboard.copy": "Copy to clipboard", "search.result.more.one": "1 more on this page", "search.result.more.other": "# more on this page", "search.result.none": "No matching documents", "search.result.one": "1 matching document", "search.result.other": "# matching documents", "search.result.placeholder": "Type to start searching", "search.result.term.missing": "Missing", "select.version": "Select version"}}</script> <script src="../../assets/javascripts/bundle.83f73b43.min.js"></script> </body> </html>