This document outlines the clinical safety process and workflow intended for use with any project undertaken in accordance with DCB0129 guidelines and the supplier clinical safety management system (CSMS). The CSMS is the process by which an organisation manages their clinical safety activities. It outlines the process, roles and responsibilities in the production of clinical safety documentation and standard compliance.
It should be used to support the development, deployment and implementation processes that are already well documented workflows in the agile approach adopted by the supplier in the delivery of healthcare IT systems to health organisations.
Each section in this document relates to an action, milestone or document that needs to be completed during the project lifecycle with clear instruction given on when and who is responsible for its production/completion.