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software and computer systems have become ubiquitous in our lives and work environment to such an extent that we forget about how much we depend on them numerous software tools are used within manufacturing and as part of quality management systems an increasing number of medical devices include software sometimes to deliver new technologies and applications sometimes to improve the ease of use of an existing system software validation seeks to ensure that all this software functions properly validation provides confirmation that a software item conforms to user needs and intended users it also seeks to guarantee that the software performs consistently without failures or safety problems why a software validation important its criticality for medical devices was brought to the forefront in 1987 with the withdrawal from the market of the therac-25 a computer-controlled radiation therapy device during the previous two years several patients received massive overdoses of radiation about
