Software Testing in Clinical Risk Management

The purpose of testing software is to perform verification and validation. These two concepts are different and understanding that difference is more than just a question of semantics. In order to assure a system and obtain the necessary evidence for the safety case, strategies for both verification and validation need to be in place. 

Fundamentally verification asks the question Are we building the product correctly . hi other words if we accept that the requirements and specification are correct, are we creating a product which meets them Is all the functionality present Does the system behave in the way that was intended Verification is an activity usually executed by software developers and generally doesn t require a deep understanding of the subject matter. Some level of verification can be achieved by examining documentation alone and doesn t necessarily require access to the system or its code. 

To evidence the safety profile of a system both verification and validation are necessary. Verification ensures that the requirements which are critical for mitigating hazards are taken into account and successfully result in working code. It checks that those features which could introduce risk if not implemented correctly, function as intended. Validation provides a means of ascertaining whether design and engineering based controls are effective in the context of the wider systan. It also provides a view on whether there are any hazards which were previously unforeseen and which might only become obvious once the big picture is clear. 

Currently there are no specific standards which prescribe HIT software testing methodologies outside of formal medical device regulation. There are however a number of standards such as ISO/IEC 25010 2011 [3] which set out general requirements of software testing and quality management. 

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