Quality
We are deeply committed to creating quality solutions that enable our customers to meet the critical business requirements of the industries in which they operate.
Quality Management
Our ISO 9001 certified Quality Management System (QMS) focuses on operational excellence and risk management.
Based on common business processes and infrastructure, we apply a global operational governance model to manage quality across the software development lifecycle.
Quality by Design
This whitepaper outlines Dassault Systèmes’ approach to quality management for the 3DEXPERIENCE platform and applications as well as other software portfolios that adhere to our global QMS.
ISO 9001:2015 Quality Management System
Scope includes design, development, deployment, cloud operations, and support for the 3DEXPERIENCE platform and other software portfolios under our global QMS.
Quality Resource Center
Includes additional Dassault Systèmes quality resources for specific industries, brands and solutions.
Dassault Systèmes risk-based approach to software quality assurance
Dassault Systèmes helps enable the regulatory requirements of our Life Sciences customers by providing on-going functional risk assessments of our cloud-based 3DEXPERIENCE platform roles.
This whitepaper describes our approach to functional risk assessments [based on GAMP5: A Risk-Based Approach to Compliant GxP Computerized Systems] and the validation testing evidence that we produce.
Dassault Systèmes position paper – Electronic records & signatures
This position paper provides insight into how our software solutions help enable customer regulatory compliance with the requirements of the US Food and Drug Administration (FDA) 21 CFR Part 11 and the European Unions’ EU Annex 11.
ASME nuclear quality assurance [NQA-1] certification
Verifies adequacy, compliance, and effectiveness of the Dassault Systèmes Quality Management System to the American Society of Mechanical Engineers (ASME) NQA-1:2022. The scope of the certification includes NQA-1 requirements applicable to software providers and requirements of US 10 CFR Part 21.
BIOVIA quality statement
Learn more about BIOVIA’s Quality Management System (QMS) and how leveraging the BIOVIA QMS can support our customer’s Computer Software Assurances (CSA) for utilizing BIOVIA software in a regulated, validated environment.
BIOVIA compliance readiness
Learn how BIOVIA products and QMS are designed for compliance readiness to enable our customers to be compliant to US FDA 21 CFR Part 11 and EU Annex 11.
BIOVIA validation kit overview
Learn how the BIOVIA validation kits can reduce the validation effort for testing product functionality.