Quality

Customer satisfaction, continuous improvement, and value creation depend on the strength of our quality practices.

Quality Management

Our multi-faceted and proactive approach to quality management follows industry best practices to deliver high-quality solutions and help customers meet regulatory requirements.

Quality by Design

By embedding quality into each stage of the software development lifecycle, our robust Quality Management System (QMS) helps ensure the 3DEXPERIENCE platform and other 3DS offerings consistently meet customer expectations.

ISO 9001 Certified

Our QMS governing the 3DEXPERIENCE platform, SIMULIA’s structural simulation offerings, and SOLIDWORKS solutions is certified to ISO 9001:2015 for design, development, deployment, cloud operations, and support activities.

Quality Resources

Review our quality-related certificates, whitepapers, and compliance documents.

Quality by Design

3DEXPERIENCE PLATFORM

A well-defined QMS governs the software development lifecycle (SDLC) for the 3DEXPERIENCE platform, integrating risk-based planning, automated testing, and compliance-ready traceability.

ISO 9001:2015

3DEXPERIENCE PLATFORM

Our QMS governing the 3DEXPERIENCE platform, SIMULIA’s structural simulation offerings (Abaqus, fe-safe, and Tosca), and SOLIDWORKS solutions is certified to ISO 9001:2015.

GAMP®5: A Risk-Based Approach to GxP Compliance

3DEXPERIENCE platform

A risk-based approach to software quality assurance on the 3DEXPERIENCE platform helps ensure systems remain agile, compliant, and continuously validated in a dynamic regulatory environment.

21 CFR Part 11 & EU Annex 11: Electronic Records & Signatures

3DEXPERIENCE platform

The 3DEXPERIENCE platform meets rigorous standards for secure, traceable, and trustworthy electronic records and signatures to support compliance requirements across regulated environments.

ASME NQA-1: Nuclear Quality Assurance

3DEXPERIENCE platform

Our QMS is certified to ASME NQA-1:2022 for key quality system requirements, including compliance with U.S. 10 CFR Part 21, affirming our commitment to nuclear-grade software quality and regulatory readiness.

BIOVIA QMS for Life Sciences & Healthcare

BIOVIA PORTFOLIO

The BIOVIA Quality Management System incorporates FDA and GAMP guidelines, ISO 9000 and IEEE standards, and iterative SDLC processes—including formal change control, validation planning, and secure development practices—to deliver compliant software for regulated environments.

BIOVIA Compliance Readiness: Controls for Regulatory Support

BIOVIA PORTFOLIO

The BIOVIA portfolio is designed to support regulatory compliance and minimize customer validation efforts, with built-in features such as audit trails, electronic signatures, and traceability—alongside validation kits and Installation Qualification (IQ) documentation to streamline deployment and change control.

BIOVIA Validation Kit Overview: Streamlined On-Site Validation

BIOVIA PORTFOLIO

To help customers accelerate Operational Qualification (OQ), support change control, and meet GxP validation requirements while deploying BIOVIA, we provide pre-executed and reusable test cases, traceability matrices, and risk impact assessments are aligned with GAMP®5 and CSA principles.