Computer system

Electronic data capture systems, electronic diaries and imaging platforms are all computer systems in this sense. ISO 14155 expects them to be validated for their intended use and protected against unauthorized changes.

hardware and software (including associated documents, e.g., user manuals) that creates, modifies, maintains, archives, retrieves, or transmits in digital form information related to the conduct of a clinical investigation (3.8)

ISO 14155:2020, clause 3.13