Twelve good practice steps cover developing products and applications and providing support and services: set up a QMS giving documented procedures and standards, trained and competent people, proof of conformance and continual improvement, including up-to-date software methods and tools; establish the requirements that the regulated company defines or supplies; plan quality, stating how the QMS applies to the product, application or service; assess sub-suppliers formally; write specifications that satisfy the requirements; review designs against requirements, standards and known risks; build software and configuration to set standards, with code review; test against approved plans and specifications; release commercially through a formal process, which is distinct from release into the GxP environment; supply user documentation and training as the contract says; support and maintain the system in use under a described change process; and handle replacement and retirement through a documented process, helping the regulated company retire systems where that has been agreed.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.