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    Validating software process

    Managing the process validation lifecycle in Val Genesis enables the ability to integrate the 3 stages of the lifecycle including process Design/Development, Qualification and Continuous Process Verification.

    Managing the process validation lifecycle in Val Genesis provides the ability to have a central repository for all data and documentation related to product design, development and validation.

    Verification is a static practice of verifying documents, design, code and program.

    It includes all the activities associated with producing high quality software: inspection, design analysis and specification analysis. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful.

    While ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) regulations are not as clear about the validation process, they do require that software development lifecycle processes be followed in areas where they apply because software validation demonstrates evidence which provides a high degree of assurance that a specific process will consistently produce the expected result.

    Your initial system assessment should provide you with the list of your systems which require validation. All of these systems fall under FDA regulation, but you can see from the connecting lines that ISO and SOX controls, also apply.

    The process of evaluating software during the development process or at the end of the development process to determine whether it satisfies specified business requirements.

    Validation Testing ensures that the product actually meets the client's needs.

    You will encounter (or have encountered) all kinds of usage and interpretations of those terms, and it is our humble attempt here to distinguish between them as clearly as possible.

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    The new process validation guidance recommends, the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

    It is nearly impossible to adopt and manage the new process validation process without the use of adequate software systems and tools.

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