When introducing a new system similar to an existing one, such as laboratory, secondary manufacturing or packaging equipment, the regulated company leverages its own activities and information from the existing system, such as requirements, risk assessments, plans, design reviews, and test specifications and results. The replacement system is assessed and any differences identified and managed with appropriate specification and verification, a review determines which existing information can be used as is or updated, the conclusions are documented, the new system is installed and verified against user requirements, and the validation report explains the rationale for the reuse.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.