Industries

Support GxP compliance with documented quality management

Designed for quality management and validation processes
Brings together documentation with full traceability
Supports GxP and international standards such as ISO 13485, FDA and EU GMP Annex 11

With D4InfoNet, you get a platform that helps you document quality, ensure traceability and support the regulatory requirements governing the development, manufacture and management of medicinal products and medical devices.

Support GxP and international standards

Whether you work with medical devices, diagnostics, laboratories or pharmaceutical manufacturing, D4InfoNet helps you to structure your quality management processes and demonstrate that they meet applicable regulatory requirements.

The platform supports organisations working in accordance with GxP, ISO 13485, MDR, FDA 21 CFR Part 11, IVDR and EU GMP Annex 11, providing a strong foundation for a modern quality management system.

Track every change with a complete audit trail

The industry’s stringent regulatory requirements demand that every change can be documented and verified. D4InfoNet automatically registers changes, versions and approvals, giving you complete traceability across your quality documents.

Gain a complete audit trail showing what was changed, when it was changed and who approved the change – helping you support data integrity, GxP compliance and regulatory audits.

Learn more about validation

Platform tools

Everything you need for quality management in the pharmaceutical and medical device industries

D4InfoNet brings together the core quality management tools in a single platform. This provides a shared overview, reduces manual processes and makes it easier to demonstrate compliance.