[What do we expect from Radiopharmacy software?]

The Radiopharmaceutical Health Products circuit or RHP (radiopharmaceutical drugs, radiopharmaceutical preparation and radioactive implantable medical devices) is a complex process that nowadays requires computerization. This circuit must be in accordance with both the legislation on medicinal products and the legislation on artificial radioelements. It is acknowledged that computerization of the circuit; possibly different within each organization, provides assistance to stakeholders: pharmaceutical analysis of prescription, pharmaceutical preparation and preparation of doses to be dispensed and waste management for example. The software also allows real-time monitoring of the activity and traceability of the various pharmaceutical processes. In addition, they are generally interfaced with equipment used routinely: dose calibrator, dose dispensing equipment. In the absence of any legislation for these software products, which are not considered either as medical devices or as software to assist prescription or dispensation, a working group, under the aegis of the Société Française de Radiopharmacie (SoFRa), has written a minimum set of specifications for these radiopharmaceutical software products. The analyses of the risk maps of different hospital structures allowed a global analysis and synthesis of the different processes, settings, interfaces and requirements for the proper use of these software. The specifications include the very specific requirements of radiopharmacy (notion of radioactive decay, complex preparations with chemical synthesis, traceability.) and will allow software publishers to propose tools adapted to our practice and the RHP circuit.