Pharmaceutical and medical devices companies may take more time to adopt cloud-based software applications, such as ERP systems, than the average non-regulated company. The technology and related service models challenge what this type of companies…
Life Science Consultant / Computer System Validation Expert, itelligence Benelux
Steven de Bruijn is a Life Sciences Consultant for itelligence in The Netherlands. He is able to bridge the gap between quality assurance and information technology, using his regulatory knowledge to support clients reaching their goals in a compliant manner. Steven specializes in validation & IT compliance, and is experienced in applying GAMP 5® practices to environments that are required to comply with e.g. 21 CFR Part 11, Annex 11, or ISO 13485:2016. In addition, his work focuses on software solutions, including SAP S/4HANA, SAP ECC, learning management systems and a range of applications commonly used in the regulated sector. He has worked with domestic and international clients in the areas of blood and plasma, biopharmaceuticals, animal health, over-the-counter drugs, and medical devices.