A process whereby information relevant to the Regulation is documented and securely held at the manufacturer and can be made available to the approval authority or technical service on request. The Interpretation Document: two parts, how the information is stored and secured (the IT security at the manufacturer: access, server, monitoring, configuration and quality controls, with ISO 27001 or ISO 9001 as evidence) and how it is made available (a contact point and an agreed file transfer platform).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.