An up-to-date system description is available for critical GxP regulated systems, as EU Annex 11 requires, setting out the physical and logical layout, the flows of data, interfaces with other systems or processes, prerequisite hardware and software, and security measures; it lets regulators and newcomers grasp what the system is for, is written in non-technical language, may be a separate document for complex multi-site systems or part of another specification for simpler ones, may start early and evolve through development, is complete before operational release, and falls under change control and is reviewed periodically. Contents cover the system's context at departmental, site, divisional or global level, the main functionality both GxP and non-GxP with diagrams, regulatory impact and the key GxP functions, the computing environment with infrastructure, user, equipment, system and external interfaces, data flows and security features, the main hardware and software components with references to configuration documentation, interfaces and data flows, access control, security controls including data protection software, electronic records and signatures used, and a glossary, without repeating detail held in other specifications.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.