Glossar Archiv » QFINITY

Coding

Coding is the generation of program code to create software modules. The coding is subject to programming guidelines, which define the quality requirements for code generation and thus ensure the traceability of the program code. The correctness of the generated…

Computer

A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention.…

Computer Software Assurance (CSA)

Computer Software Assurance is the FDA’s risk-based approach for establishing and maintaining confidence that software is fit for its Intended Use – in the guidance’s own wording, the Intended Use of the software as part of production or the quality…

Computer System

Computer systems are a combination of hardware, software, and firmware that work together to perform specific tasks. They consist of various components such as processors, memory, input and output devices, and operating system software. These components work together to process,…

Computerized System

The term computerized system covers a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution,…

Computerized System Validation

Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation…

Context of Use

Context of Use (CoU) is the specific role and scope of an AI model used to address a Question of Interest – the FDA’s articulation of the Intended Use at the process level. The CoU spans forward: it defines the…