Configuration Control vs. Document Control
Managing Design Changes Across Modern Quality Systems
- Configuration Control versus Document Control
- Configuration Architecture and the Single Source of Truth
- Requirements, risks, controls, outputs, suppliers, and evidence relationships
- Generated documents as views of approved configuration information
- Change impact assessment across configuration objects and relationships
- Configuration integrity across Design Controls and manufacturing
- PLM, MES, ERP, Digital Thread, and Digital Twin integration
- Inspection readiness through coherent configuration states and evidence
When a design change occurs, the critical task is determining which product, process, risk, supplier, software, and evidence relationships are actually affected.
This session structures a configuration-first approach to managing approved product information, relationship integrity, change impact, and generated documentation across modern Quality Systems.
The session begins by separating document control, configuration control, and Configuration Architecture, then examines how product information and relationships should be structured around a Single Source of Truth. It progresses into change impact, generated document views, configuration integrity, and the architecture supporting connected quality, manufacturing, engineering, and regulatory systems.
José Ignacio Mora brings more than 30 years of medical device and life sciences experience spanning manufacturing engineering, quality systems, process development, tooling, and product realization. His leadership roles at Boston Scientific and Stryker Orthopedics, combined with extensive hands-on work in design, manufacturing, validation, and quality systems, provide direct practical grounding for Configuration Architecture and change management.