How to validate radiopharmaceuticals management software?

Abstract

Abstract In the context of securing medication management systems (MMS) in healthcare habilities, implementation of an electronic MMS is a priority area of work. The quality requirements for the production of radiopharmaceuticals have increased significantly in the field of radiopharmacy. The deployment of Information Technology (IT) tools is essential to secure the radiopharmaceutical medication use process. The aim of this work is to propose the first consensual tool to validate radiopharmacy software approved by a panel of experts. A literature review was conduced related to the validation of hospital pharmacy software. The Delphi method was chosen for achieving a consensus in this study. Surveys were sent by mail to selected experts involved in the MMS. Twenty-seven replies were recorded (77%) to the first round, and 17 responses were recorded to the second survey. The final tool is a grid with 44 items. We proposed the first consensual tool to validate radiopharmacy software. This tool could be implemented in all French radiopharmacy to improve quality.