Software validation has become an integral part of the overall software lifecycle when it comes to using a software application in a regulated environment. If the application is defined as being GxP system or critical to quality the end result means that a high degree of testing is required in order to allow the application to be used in the manufacturing process.
What should happen is that a comprehensive Vendor Audit needs to be carried out, to ensure that the system has been developed to the highest of quality standards. This approach is essential so that you have a high degree of assurance that the system is sound, and can be leveraged from later in at the validation stage.
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