BAYOOSOFT Risk Manager has been the globally leading and validated software solution for preparing technical documentation for manufacturers of medical devices and in-vitro diagnostics since 2000.
BAYOOSOFT Risk Manager is a software solution validated according to GAMP 5, which guides you through the standard requirements in a structured way, also using illustrative examples provided. You are automatically shown smart suggestions at relevant points thanks to the self-learning knowledge database included in the basic module. In this way, the application automatically analyzes all documents ever created with BAYOOSOFT Risk Manager in your company in real time – as you enter text – and recognizes whether other hazards or causes were identified with other similar products in the past, or whether measures were implemented which you have not yet considered with the current product. With its efficiency calculator, BAYOOSOFT Risk Manager also determines which measures could be particularly efficient, for example, and presents you these suggestions accordingly.