_______________________________________________________________________________________________________ 📅 August 31, 2026 | 🕒 11 PM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes
This is not a webinar about document control. It is a webinar about Configuration Architecture and the architecture of a modern Quality System. Traditional systems often treat requirements, risks, risk controls, design outputs, software, hardware, manufacturing processes, suppliers, verification, validation, regulatory evidence, training, equipment, tools, locations, and documents as separate categories. The real product, however, is defined by the relationships among those elements.
Those relationships must be treated as first-class objects. They show which requirement is implemented by which design output, which risk is addressed by which control, which software version operates with which hardware configuration, which supplier provides which component, which process produces which output, and which verification or validation evidence supports an approved configuration state. A document may present those relationships, but the document is not the architecture. A traceability matrix may display relationships, but traceability is evidence of relationship integrity; it is not the architecture itself.
The webinar challenges several common assumptions:
The distinction is fundamental:
Configuration Architecture establishes the objects, relationships, references, states, and evidence required to understand what a product is, how it is made, how it is verified and validated, how it is supplied, and how it remains compliant throughout its life cycle.
Under this model, documents are not merely outputs. They are user interfaces into the approved configuration. Different users require different representations of the same configuration:
These are different views or interfaces into the same approved configuration—not independent bodies of truth.
The practical Lean Documents principle is direct:
Information should never travel. References travel. Information remains in the Single Source of Truth.
Every copied piece of information creates another synchronization problem. Every disconnected relationship creates uncertainty about impact, status, and evidence.
When a change is made, the question is not merely, “Which documents must be revised?” The more important question is, “Which configuration objects and relationships are affected?” That shift improves change impact assessment, reduces document synchronization effort, strengthens Design Controls, and makes regulatory evidence more coherent.
A Configuration-First Quality System provides a common enabling architecture for Design Controls, Risk Management, Verification, Validation, Supplier Control, Manufacturing, PLM, MES, ERP, Digital Thread, Digital Twin, Artificial Intelligence, and Inspection Readiness. These are not separate initiatives that happen to exchange information. They depend on the same foundation: reliable approved configuration information and intact relationships.
Configuration integrity is the objective. Traceability is one of the outcomes.
A modern Quality System should control the configuration first and generate the documents second.
The product exists independently of its documentation. Configuration defines the product. Documents are generated views and user interfaces into the approved configuration. Traceability demonstrates that relationships are intact, but it is not a substitute for the architecture that creates and maintains those relationships.
Information should never travel. References travel. Information remains in the Single Source of Truth.
The primary audience includes managers, engineers, auditors, consultants, and technical professionals who need to understand how configuration decisions affect product quality, regulatory evidence, manufacturing execution, and change control.
The webinar is particularly relevant to professionals who manage large document sets, investigate inconsistencies, conduct change assessments, support inspections, or evaluate digital Quality System investments. It is also designed for leaders who need a coherent foundation for PLM, Digital Thread, Digital Twin, connected manufacturing, Model-Based Engineering, and AI-enabled Quality Systems.
This webinar will benefit professionals responsible for defining, developing, manufacturing, assuring, releasing, maintaining, or regulating medical devices, including:
Every Quality System ultimately depends on one question: What is the approved product?
That question must be answered consistently across requirements, design outputs, software, hardware, manufacturing processes, suppliers, risk controls, verification, validation, and records. Configuration Architecture answers one question: What is the approved product? Everything else in the Quality System exists to support, communicate, verify, validate, manufacture, or preserve that answer.
Most Quality Systems still assume that the product is defined by its documents. That assumption is no longer adequate. The product exists independently of its documentation. Documentation may describe the product accurately, incompletely, or incorrectly. The approved configuration determines which of those is true. A document can be perfectly controlled—approved, current, distributed, and retained—and still describe the wrong product. Document Control can function exactly as designed while configuration integrity has already been lost.
This webinar examines the evolution from Paper Documents, to Electronic Documents, to Connected Information, to Configuration Architecture, and ultimately to Generated Document Views. Moving paper into an electronic repository did not solve the underlying architectural problem. In many organizations, electronic document systems simply recreated paper-based thinking electronically: the same information was copied into more files, more approval cycles were created, and every change produced another synchronization problem.
The modern alternative is a Configuration-First Quality System. The approved configuration is the Single Source of Truth (SST) and the organizing principle of the architecture.
Every controlled object should either:
This is the central discipline of Lean Documents and Lean Configuration. Documents remain necessary, but they are not independent bodies of truth. They are generated views—and user interfaces—into the approved configuration.
José Ignacio Mora is a seasoned Principal Consultant specializing in Manufacturing Engineering and Quality Systems, with over 30 years of experience in the medical-device and life-sciences industries. His expertise lies in manufacturing, process development, tooling, and quality systems. Before joining Atzari Consulting as a consulting partner, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics.
José has an impressive track record of leading the successful launch of manufacturing at a startup urology products company and creating a world-class medical device manufacturing operation using JIT, kanban systems, visual workplace, and lean manufacturing practices. His expertise extends to surgical instruments; PTA and PTCA dilatation and guiding catheters; plastic surgery implants and tissue expanders; urology implants and devices; delivery systems for brachytherapy; orthopedic implants and instruments; and vascular surgery grafts and textiles.
José has received training in, and has decades of hands-on experience applying, world-class methodologies, including Kepner-Tregoe, Taguchi techniques, the Theory of Constraints, Lean Manufacturing, 5S (Visual Workplace), process validation to Global Harmonization Task Force (GHTF) guidance and standards, and similar approaches.