Ib Alstrup

Ib Alstrup has served as a Medicines Inspector for GxP IT at the Danish Medicines Agency since 2017, leading inspections of the pharmaceutical industry’s use of IT systems across all GxP areas. His work focuses on ensuring system and data integrity, including system validation, secure operations, and most recently, the application of AI/ML in critical contexts, for which he proposed a structured set of evaluation questions in 2021. He has contributed to numerous international guideline drafting groups, including the PIC/S Data Integrity Guideline, OECD GLP guidelines on Data Integrity, Cloud Computing, and Security, and the EMA Guideline on Computerised Systems in GCP. Since 2019, he has chaired the drafting group and served as EMA rapporteur for the revision of EU and PIC/S GMP Annex 11 on Computerised Systems, as well as the development of the new GMP Annex 22 on Artificial Intelligence. With over 30 years of experience in software design, testing, quality assurance, auditing, and inspection, Ib brings both technical expertise and deep regulatory insight to his role. He holds a degree in electronic engineering with a specialization in software.