LDLCLean Documents and Lean Configuration
Resources

The framework in
depth.

Webinars, articles, white papers, framework diagrams, and reference materials. Organized by topic — not by catalog number.

Design ControlsRisk ManagementValidationQuality SystemsSupplier QualityRegulatory AffairsOperational ExcellenceSoftware and eQMSDesign ControlsRisk ManagementValidationQuality SystemsSupplier QualityRegulatory AffairsOperational ExcellenceSoftware and eQMS
Topic Category 01
Design Controls
The DHF Is Not a Folder: Design History File Architecture under ISO 13485 and 21 CFR Part 820
Most organizations treat the DHF as a document repository. This webinar examines the DHF as a governed information architecture — defining what belongs in it, what the relationships between records must be, and how to demonstrate DHF coherence during inspection.
DHF · 100624ISO 1348521 CFR Part 820Design Controls
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URS to TDR: Governing the Translation from User Needs to Verifiable Requirements
The gap between what users need and what engineers specify is where design control failures begin. This webinar examines the governed derivation relationship between URS 401042 and TDR 401087 — what it means for a technical requirement to be derived, and how to demonstrate that derivation.
URS · 401042TDR · 401087Design InputsTraceability
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Design Transfer: When the DHF Becomes the DMR
Design transfer is not a signature event. It is a governed configuration transition in which the design baseline becomes the production baseline. This webinar examines the work unit 600515 (Perform Design Transfer) and the governance requirements for ensuring DMR 100518 reflects the final approved design.
Design Transfer · 600515DMR · 100518Configuration Baseline
Planned
EU MDR Technical Documentation as a Governed Evidence Package
EU MDR Technical Documentation is not a regulatory filing. It is a living governed evidence package that must be maintained in coherence with the device, the risk file, the clinical data, and the post-market surveillance plan. This webinar examines the governance architecture for Technical Documentation 100781 and 100782.
EU MDR 2017/745Tech Doc · 100781Section 6Section 9 PMS
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Topic Category 02
Risk Management
The Risk Management File Is Not a Document: ISO 14971:2019 as a Governed Information Architecture
ISO 14971:2019 does not specify documents — it specifies a process that produces governed records. This webinar examines the Hazard Analysis (100312), risk controls, verification acceptance criteria (401427), and residual risk records as a governed information structure rather than a document set.
ISO 14971:2019Hazard Analysis · 100312Risk ControlsVAC · 401427
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Change Impact on the Risk File: When a URS Revision Propagates into the RMF
Using the Change Propagation Explorer scenario — URS 401042 revision propagating into Hazard Analysis 100312 and V&V Protocol 100427 — this webinar demonstrates how ISO 14971 risk controls must be reassessed when design inputs change.
Change PropagationURS · 401042RMF · 100312ECN · 401247
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PMS-to-RMF: Closing the Post-Market Feedback Loop
Post-market signals that do not reach the Risk Management File represent an open governance loop. This webinar examines how PMS plan (100782) signal thresholds connect to RMF review triggers and what a governed feedback loop looks like in practice.
PMS · 100782PMCFRisk Review · 600781ISO 14971 §10
Planned
Topic Category 03
Validation
Validation Traceability: From Process Requirement to IQ/OQ/PQ Evidence
Validation records are governed information units. This webinar examines the derivation chain from process requirement to acceptance criterion (401427) to verification protocol (100427) to report (100428) — and what happens to that chain when process requirements change.
IQ / OQ / PQV&V Protocol · 100427VAC · 401427Process Validation
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When Does a Prior Validation Still Apply? The Undocumented Assumption
The most common validation failure mode is the undocumented assumption that a prior validation still applies after a change. This webinar examines change impact assessment as a validation governance discipline — using V&V Report 100428 invalidation as a worked example.
Change ImpactV&V Report · 100428Validation Maintenance
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Software Validation under IEC 62304: Lifecycle Documentation Governance
IEC 62304 software lifecycle documentation is a microcosm of the LDLC governance problem. This webinar applies the LDLC framework to software requirements, architecture, detailed design, verification, and release records.
IEC 62304Software Validation21 CFR Part 11eQMS Validation
Planned
Topic Category 04
Quality Systems
The Quality Manual as a Governance Map, Not a Clause Index
Most Quality Manuals (100060) are organized by ISO clause. This webinar examines the alternative: a Quality Manual organized by governance architecture — showing how processes, records, and relationships are structured, rather than which clauses they satisfy.
Quality Manual · 100060ISO 13485Governance ArchitectureQMS Structure
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CAPA as a Governed Work Unit: From Root Cause to Record Correction
CAPA is not a document type. It is a governed work unit (6xxxxxx) that produces information objects (4xxxxxx) and ultimately produces corrected records (1xxxxxx). This webinar applies the LDLC ontology to CAPA architecture, separating the work from the notice from the deliverable.
CAPAWork Units · 6xxxxxxRoot CauseEffectiveness Check
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FDA QMSR Transition: What 21 CFR Part 820 Alignment with ISO 13485 Actually Requires
The QMSR transition is not a document update exercise. It requires organizations to examine their quality system architecture and align it with the ISO 13485:2016 structure. This webinar examines the transition implications for design controls, risk management, and supplier quality governance.
QMSR21 CFR Part 820ISO 13485:2016QMS Transition
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Topic Category 05
Supplier Quality
Critical Component Governance: From Supplier Account to Finished Device Assembly
The governance chain from Material Supplier (700021) to Polymer Resin (900118) to Patient-Contacting Component (900221) to Finished Device Assembly (900374) must be explicit and maintained. This webinar examines supplier quality as a configuration management problem.
Supplier · 700021Part · 900118Critical ComponentsASL Governance
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Incoming Inspection as a Governed Record: SOP 100524 and Work Instruction 100531
Incoming inspection procedures are governed records — they derive from material specifications (100519), which derive from design requirements (TDR 401087). When the specification changes, the inspection procedure must be assessed. This webinar examines the governance chain and what it means for change control.
Incoming Inspection · 100524Material Spec · 100519Change Control
Planned
Topic Category 06
Regulatory Affairs
Inspection Readiness Is Not Document Readiness: Demonstrating Coherence Under Audit
The ability to demonstrate a governed relationship between records under inspection conditions is different from the ability to produce the records themselves. This webinar examines what inspection readiness actually requires — and why document management systems alone cannot provide it.
Inspection ReadinessFDA 483ISO 13485 AuditCoherence
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ANVISA RDC 665: Brazilian Medical Device Regulations in the ISO 13485 Context
ANVISA RDC 665 aligns Brazil's medical device quality system requirements with ISO 13485:2016. This webinar examines the regulatory structure, the differences from FDA and EU MDR requirements, and the governance implications for organizations seeking ANVISA registration.
ANVISA RDC 665Brazil RegistrationISO 13485Multi-Market
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Topic Category 07
Operational Excellence
Lean Thinking in a Regulated Environment: What Lean Actually Means for QMS
Lean Documents and Lean Configuration are not metaphors borrowed from manufacturing. This webinar examines what lean thinking — specifically the elimination of waste — actually means when applied to document governance, record maintenance, and quality system architecture in regulated industries.
Lean ThinkingQMS EfficiencyDocument GovernanceWaste Elimination
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The ECN as a Work Unit: Separating the Action, the Notice, and the Deliverable
The Engineering Change Notice is simultaneously a work unit (600247 Create ECN), an information object (401247 ECN), and a producer of deliverables (100842 Updated Design Output Package). Collapsing these three into a single concept is a persistent source of governance failure. This webinar examines the distinction and its practical implications.
ECN · 401247Work Unit · 600247Change ControlLDLC Ontology
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Topic Category 08
Software and eQMS
eQMS Configuration Is a Governance Problem, Not a Software Problem
Organizations that implement eQMS systems without first defining their governance architecture automate their existing governance failures. This webinar examines eQMS configuration from the LDLC perspective — defining document types, relationship rules, and workflow governance before selecting or configuring a system.
eQMS ConfigurationLean ConfigurationGovernance ArchitectureSystem Validation
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ERP Integration with Quality Records: The Configuration Synchronization Problem
When ERP systems and eQMS systems hold overlapping records — BOMs, part specifications, supplier records, production orders — configuration synchronization becomes a critical governance problem. This webinar examines the LDLC approach to ERP/eQMS integration governance.
ERP IntegrationConfiguration SynchronizationBOM GovernanceDMR · 100518
Planned
Framework Article
The Cross-Reference Problem: Why Every Document References Every Other
Medical device documentation systems develop an unwritten rule over time: every document must reference every related document. The intent is traceability. The result is a tangled web in which no single change can be contained, no single document can be maintained independently, and no audit can follow the thread from requirement to evidence without reconstruction. This article examines how the cross-reference problem develops and what the LDLC framework proposes in its place.
Design Controls · Risk Management · Governance Architecture
Framework Article
What Configuration Management Means Outside of Software
Configuration management is a software engineering discipline that has been applied, imperfectly, to medical device documentation for decades. This article examines what configuration management actually means when applied to the full device lifecycle — requirements, specifications, physical artifacts, quality records, and the relationships between them — and why Lean Configuration is the natural extension of that discipline into the governed document architecture.
Lean Configuration · DHF · DMR · Design Controls
Regulatory Analysis
FDA QMSR: What the Alignment with ISO 13485:2016 Actually Changes
The FDA Quality Management System Regulation represents the most significant structural change to U.S. medical device quality requirements in more than two decades. This article examines what the QMSR transition actually requires of organizations beyond document updates — and where the LDLC framework applies to the transition architecture.
21 CFR Part 820 · QMSR · ISO 13485:2016 · FDA
Case Analysis
The Inspection That Found Nothing Wrong: How Coherence Failures Hide in Plain Sight
An examination of the pattern in which regulated organizations pass inspection without discovering the governance failures that will surface in the next inspection. The documents are present. The signatures are present. The relationships are assumed. The coherence failure is invisible until the auditor asks the right question — or until a product problem makes it visible in a different context.
Inspection Readiness · Coherence · Design Controls · Risk Management
Framework Article
Biocompatibility Governance: Why URS 401042 Cannot Be Revised in Isolation
Using the Change Propagation Explorer scenario as a worked example, this article traces the full governance implications of a URS revision for biocompatibility requirements — through TDRs 401087 and 401088, Hazard Analysis 100312, V&V Protocol 100427, V&V Report 100428, Material Specification 100519, and EU MDR Technical Documentation sections 100781 and 100782 — demonstrating why sixteen records must be assessed and why ECN 401247 / Work Unit 600247 must govern the entire event.
Biocompatibility · Design Controls · Risk Management · EU MDR · Change Control
Framework Article
LDLC Ontology: Why the Work, the Notice, and the Deliverable Are Not the Same Object
The LDLC numbering ontology separates objects that most quality systems collapse: the work unit (6xxxxxx) that governs an activity, the information unit (4xxxxxx) that records it, and the document (1xxxxxx) that results from it. This article examines why the distinction matters — using Create ECN (600247), Engineering Change Notice (401247), and Updated Design Output Package (100842) as the primary example — and what governance failures result from collapsing the three into one.
LDLC Ontology · ECN · Change Control · Work Units · Information Units
White Paper · Design Controls

Design History File Architecture: A Governance-Oriented Framework

A structured examination of DHF 100624 as a governed information architecture rather than a document repository. Covers the relationship between DHF and DMR, the governance of design inputs and outputs, and the role of the DHF in inspection readiness. Includes worked examples using the LDLC demonstration dataset.

White Paper · Risk Management

Risk Management File Coherence: ISO 14971:2019 as a Governance Architecture

An examination of the RMF as a governed information structure under ISO 14971:2019. Covers hazard analysis governance (100312), risk control traceability to verification evidence (401427, 100427), and the PMS-to-RMF feedback loop. Includes the biocompatibility change propagation scenario as a worked example.

White Paper · EU MDR

Technical Documentation Governance under EU MDR 2017/745

EU MDR Technical Documentation is not a regulatory submission — it is a living governed evidence package. This white paper examines the governance architecture for Technical Documentation 100781 (Section 6 biological safety) and 100782 (Section 9 PMS plan), including coherence requirements and maintenance obligations post-certification.

White Paper · Lean Configuration

Lean Configuration: Configuration Management Applied to the Full Device Lifecycle

The foundational white paper for the Lean Configuration half of the LDLC framework. Examines configuration management principles applied beyond software to requirements, specifications, physical artifacts, quality records, and supplier relationships. Includes the LDLC ontology reference and worked examples.

White Paper · eQMS

eQMS Configuration Governance: Building the Architecture Before the System

Organizations that implement eQMS systems without first defining their governance architecture automate their governance failures. This white paper provides the LDLC framework for eQMS configuration governance — document type definitions, relationship rules, workflow governance, and system validation — independent of any specific platform.

White Paper · Inspection Readiness

Inspection Readiness as a Governance Standard: Beyond Document Management

Inspection readiness is not the ability to produce records. It is the ability to demonstrate coherent, traceable relationships between records — on demand, without reconstruction. This white paper examines inspection readiness as a governance discipline and provides the LDLC coherence assessment framework.

Framework diagrams that make the LDLC governance architecture visible. Each diagram is a navigable representation of a specific aspect of the framework.

Governance Architecture
QMS Governance Architecture — Five-Layer Model
The LDLC governance architecture organized into five governance layers: Quality Manual → Design Controls → Risk Management → Device Master Record → Technical Documentation. Shows the governed relationships between all layers and the cross-cutting role of Configuration Management and Change Control.
Express Interest
Ontology Reference
LDLC Ontology Map — Object Types and Relationships
The full LDLC ontology: Documents (1xxxxxx), Serialized Units (2xxxxxx), Models (3xxxxxx), Information Units (4xxxxxx), Locations (5xxxxxx), Work Units (6xxxxxx), Accounts (7xxxxxx), File Locations (8xxxxxx), Stockable Parts (9xxxxxx). Shows the governed relationship types between each object category.
Express Interest
Change Propagation
Change Propagation Model — URS 401042 Revision Scenario
A complete change propagation diagram showing how a revision to URS 401042 propagates through TDRs, the Risk Management File, V&V records, the Device Master Record, and EU MDR Technical Documentation — governed by ECN 401247 and Work Unit 600247. Sixteen records across six governance levels.
Express Interest
Lifecycle Flow
Product Lifecycle Governance — From User Needs to Post-Market
The LDLC lifecycle governance diagram: User Needs → URS → Design Process (DHF) → V&V → Design Transfer (DMR) → Production → PMS/PMCF. Shows the governing records and information units at each phase, and the configuration baseline transitions between phases.
Express Interest
DHF / DMR Relationship
DHF-to-DMR Configuration Transition — Design Transfer Governance
The governed configuration transition from Design History File (100624) to Device Master Record (100518) during design transfer. Shows which records from the DHF become inputs to the DMR, which are incorporated by reference, and which are superseded by the design transfer event.
Express Interest
Trace Path
Requirement-to-Evidence Trace — URS 401042 to DMR 100518
The complete governed trace from URS 401042 (biocompatibility requirement) through TDR 401087, Hazard Analysis 100312, Verification Acceptance Criterion 401427, V&V Protocol 100427, V&V Report 100428, and into Device Master Record 100518. Shows every governed relationship in the chain.
Express Interest

Reference materials, templates, and framework tools. All downloads reflect LDLC governance principles.

Reference Sheet
LDLC Ontology Quick Reference — Object Types and Prefixes
One-page reference: 1xxxxxx Documents · 2xxxxxx Serialized Units · 3xxxxxx Models · 4xxxxxx Information Units · 5xxxxxx Locations · 6xxxxxx Work Units · 7xxxxxx Accounts · 8xxxxxx File Locations · 9xxxxxx Stockable Parts. With examples from the LDLC demonstration dataset.
Express Interest
Assessment Tool
Governance Gap Assessment Worksheet
A structured worksheet for identifying unmanaged relationships in an existing documentation system. Covers design controls, risk management, V&V traceability, supplier quality, and change control. Printable and eQMS-compatible formats planned.
Express Interest
Architecture Template
DHF Governance Architecture Template
A structured template for documenting the DHF governance architecture of a specific device — defining the records, relationships, and governance rules for design inputs, design outputs, risk management integration, and V&V traceability.
Express Interest
Reference Sheet
Change Propagation Checklist — LDLC Governance Framework
A checklist for assessing change impact across the LDLC governance layers: Information Units → Risk Management → V&V → DMR → Technical Documentation → Work Units / ECN. Based on the URS 401042 revision scenario used throughout the LDLC framework demonstrations.
Express Interest
Regulatory Reference
Standards and Regulations Reference — Medical Device QMS
A structured reference covering ISO 13485:2016, 21 CFR Part 820 / QMSR, EU MDR 2017/745, ISO 14971:2019, IEC 62304, ANVISA RDC 665, and MHLW Ordinance 169. Organized by governance domain rather than by regulatory origin.
Express Interest

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