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Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the system definition phase. System definition artifacts that reflect these requirements can include, but are not limited to, the following:
The PMBOK guide, also adopted by the IEEE as a standard (jointly maintained by INCOSE, the Systems engineering Research Council SERC, and IEEE Computer Society) defines them as follows in its 4th edition: [17] "Validation. The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders.
The term "Computerized System Validation" suggests that validation is performed by a computer, which is not the case. It is a methodology to validate computer systems. It might be good to point out that CSV is widely implemented at pharmaceutical companies.
A requirement is that both the system data and model data be approximately Normally Independent and Identically Distributed (NIID). The t-test statistic is used in this technique. If the mean of the model is μ m and the mean of system is μ s then the difference between the model and the system is D = μ m - μ s. The hypothesis to be tested ...
Independent Software Verification and Validation (ISVV) is targeted at safety-critical software systems and aims to increase the quality of software products, thereby reducing risks and costs throughout the operational life of the software. The goal of ISVV is to provide assurance that software performs to the specified level of confidence and ...
As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system." The subsequent validation or verification of computer systems targets only the "GxP critical" requirements of computer systems. Evidence (e.g. screen ...
The system can be monitored during the execution itself (online) or after the execution e.g. in form of log analysis (offline). The verifying code is integrated into the system (as done in Aspect-oriented Programming) or is provided as an external entity. The monitor can report violation or validation of the desired specification.
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000. The words "verification" and ...