Nico Erdmann

Deloitte GmbH WPG
Senior Manager
Nico Erdmann, PhD, is Senior Manager at Deloitte Germany where he is part of a team dedicated to navigating regulatory complexity in the Life Sciences industry. Leading the IT quality practice, he designs validation approaches for new technologies and IT quality frameworks for pharma and MedTech companies. Nico's special focus is on AI GxP compliance. He develops GxP compliance frameworks for ML applications and the design of E2E process enablement by AI. Nico is a committee member of the ISPE GAMP® D-A-Ch group and core member of the ISPE SIG on Software Automation & Artifical Intelligence.

Related Articles

Machine Learning Risk and Control Framework
Features
Machine Learning Risk and Control Framework

Stakeholders across industries are becoming accustomed to using information technology (IT) systems, applications, and business solutions that feature artificial intelligence (AI) and machine learning (ML). Even though some of these uses show phenomenal performance, thorough risk management is required to ensure quality and regulatory compliance are met within the life sciences industry. By...

Maturity model
Features
AI Maturity Model for GxP Application: A Foundation for AI Validation

Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many areas of the business world. The pharmaceutical industry and its GxP-regulated areas also want to use AI in a beneficial way. Several pharmaceutical companies are currently running digital pilots, but only a small fraction follows a systematic approach for the digitalization of their operations