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.

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

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The CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested. High-Risk functions should be tested more extensively with higher control in a fully scripted test. Low risk functions can be tested more informally with minimal documentation. The basis for the CSA approach is a comprehensive understanding of the process and function as well as the associated risks for the patient or the product. The CSA approach can be applied during the entire computerized system life cycle, including software development as long as the risk are understood and documented.
The CSA principles should be applied to all computer systems involved in manufacturing a medical device (and medicinal products) or the associated quality systems (e.g. ERP, LIMS, etc.). Software that is itself a component of a medical device is explicitly excluded.
The main steps of the CSA approach are:
• Define the Intended Use (at a system and/or function level)
• Define the risk-based approach for assuring the quality of the software
• Define the appropriate testing activities
In all of these steps, the CSA approach emphasizes the need for critical thinking when developing the life-cycle strategy of a computerized system, especially in terms of the scope and depth of the associated testing and documentation activities.
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A Computerized System is 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.

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

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

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