Affichage des articles du juillet, 2017

US FDA et Cloud Computing

Cette ligne directrice de la FDA donne des recommandations intéressantes sur l'utilisation des enregistrements et signatures électroniques dans les études cliniques et plus particulièrement sur l'utilisation des services applicatifs dans le Cloud : 

B. Outsourced Electronic Services  FDA recognizes that sponsors and other regulated entities may choose to outsource electronic services. Examples of these types of electronic services are data management services, including cloud computing services. According to the National Institute of Standards and Technology, cloud computing is defined as “a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.”  When these electronic services are used to process data for FDA-regulated clinical investigations, sp…