Generating the 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 code is verified in the module test. Compliance with programming standards is verified on the basis of code reviews.

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

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, and document management systems. The computerized system consists of the hardware, software, and network components, together with the controlled functions and associated processes, trained people, qualified equipment and specifications and records.

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 framework by executing project specific validation plans
  • establishing and applying appropriate operational controls throughout the life of the system

A system containing one or more computers (or hardware components) and associated software.