What is Compliance Management?

Compliance management ensures that organizations adhere to applicable laws, regulations, industry standards, and internal policies. Its primary role is to mitigate risks, maintain ethical business practices, and build trust with stakeholders. By establishing robust processes and systems, compliance management helps organizations avoid legal penalties, reputational damage, and operational disruptions.

Regulatory compliance and product safety

Ensuring products meet all applicable laws, industry standards, and safety regulations for their target markets throughout the lifecycle, from initial design through end-of-life. This typically includes performance, labelling, usage limitations, and sector-specific rules (for example, aerospace, medical, or consumer electronics).

On the 3DEXPERIENCE platform, ENOVIA, DELMIA and BIOVIA capture and manage regulatory requirements, risks, and approvals, so products consistently meet sector-specific safety and regulatory standards across all target markets.

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Environmental compliance and controlled substances

Managing materials and components so they comply with environmental regulations and substance restrictions across the BOM, manufacturing, use, and disposal phases. This covers areas such as hazardous substance bans, recycling and take-back schemes, eco-design requirements, and documentation of material declarations.

ENOVIA 3DEXPERIENCE roles such as Materials Compliance Manager centralize material data, track restricted substances, and generate environmental compliance reports against regulations like chemical content and eco-design rules.

Quality and process compliance

Aligning product development and manufacturing processes with recognized quality standards and internal policies to ensure consistent, repeatable outcomes. This involves controlled workflows, change management, CAPA, audits, and documented procedures embedded in PLM (product lifecycle management) and QMS (quality management systems).

3DEXPERIENCE with ENOVIA Quality Management delivers a total quality system that standardizes quality workflows, CAPA, and audits, embedding proactive, closed-loop quality and compliance into day‑to‑day product development.

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Documentation and traceability compliance

Maintaining complete, auditable records of requirements, designs, changes, tests, and approvals across the entire product history. Strong traceability enables organizations to demonstrate conformity during inspections and audits, quickly reconstruct design decisions, and manage issues or recalls more effectively.

ENOVIA, DELMIA and BIOVIA provide controlled, versioned records and end‑to‑end traceability of requirements, design changes, test data, and regulatory submissions, making it easier to demonstrate conformity and pass audits.

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Data, security, and privacy compliance

Protecting sensitive product, customer, and operational data in line with information security and privacy regulations. This includes access control, secure storage of technical files, controlled sharing with partners, and retention policies that align with legal and contractual obligations.

Deployed on secure 3DEXPERIENCE infrastructures, ENOVIA, DELMIA and BIOVIA support protected, role-based access to product and scientific data, helping organizations align with information security and data-integrity expectations in regulated industries.

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Supplier and supply chain compliance

Ensuring that suppliers, contract manufacturers, and other partners meet defined regulatory, quality, ethical, and sustainability requirements. Typical activities include collecting and validating certificates, material and substance declarations, and ensuring that approved parts and vendors are consistently used across the BOM.

ENOVIA connects product structures, sourcing data, and supplier documentation in a single collaborative environment, allowing teams to control approved parts, collect declarations, and monitor supplier compliance across the value chain.

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Market access and certification compliance

Managing the approvals, tests, and certifications required to place products on specific markets or operate in regulated environments. This spans conformity assessments (such as regional marks and sector approvals), ongoing monitoring obligations, and keeping technical documentation up to date as designs or regulations change.

By combining ENOVIA Quality and Compliance apps with BIOVIA Regulatory Information Management, the 3DEXPERIENCE platform orchestrates test evidence, technical files, and submissions needed to obtain and maintain market approvals worldwide.

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