Thescon Is Involved: the new VDI guideline on ML Systems in the pharmaceutical industry

Thescon Is Involved: the new VDI guideline on ML Systems in the pharmaceutical industry

Thescon contributed to the development of the VDI Guideline VDI/VDE-EE 3516 Part 7

Thescon is proud to have played a key role as part of the expert panel contributing to the new VDI expert recommendation for the application of machine learning (ML) in the pharmaceutical industry. Once again, we demonstrate our expertise in validation and quality assurance – supporting our clients in regulated industries on their path to a safe and innovative future.

Patient Safety in Focus

This VDI recommendation introduces a practical approach for safely integrating ML-based systems into existing regulatory frameworks. With our expertise in quality risk management and validation, we have made a significant contribution to establishing unified standards that sustainably enhance patient safety and the trustworthiness of such systems.

Our Contribution to Your Business

  • Reliable Risk Assessment: We provide transparent evaluations of ML systems to ensure compliance with regulatory requirements.

  • Efficient Validation Processes: Our proven methods enable the seamless implementation of ML technologies in highly regulated environments.

  • Sustainable Acceptance: Through our contribution, we have laid the foundation for collaboration between authorities, pharmaceutical companies, and ML providers on equal footing.

Rely on our expertise to ensure that the use of ML systems in your organization is future-proof and compliant. Together, we drive innovation and build the necessary trust – for greater patient safety and long-term business success.

Find the VDI Guideline here:

https://www.vdi.de/richtlinien/details/vdivde-ee-3516-blatt-7-validierung-im-gxp-umfeld-einsatz-von-verfahren-des-maschinellen-lernens-in-der-pharmazeutischen-industrie

We hope you enjoy an insightful read!