Paul Henderson on his article titled Time to Get Positive about Negative Testing, talks about how people in the QA arena are  not putting too much importance or importance at all in the value added to projects and quality of Negative Testing.  Henderson adds “For example, unusual combinations of data inputs, overflows from long running [...]

As part of the implementation of new information systems in the FDA regulated industry, we leverage some of the testing that has been performed by the software vendor.  Most of the time, as part of the software vendor audit, auditors have access to the testing documentation used to support the SDLC of the application.  One [...]

As Software QA professionals in the FDA industry, we are constantly asked to advice on how much time should be allocated for testing purposes.  How much time we end up assigning to the generation, approval and execution of computer validation protocols to test our software is always part of a big debate. Randy Rice gives [...]