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Re: IS0 13485:2003, Validation of the application of computer software
Hi Wnd54 and welcome to the cove.
In my opinion there is not a lot of difference between a software validation and a process validation in this respect. In validations you encounter bugs, obstacles, unforeseen events etc. What matters is whether you document them properly (raise a deviation), handle them in structured manner , and evaluate them objectively and consider the risk for the patients. Depending on the type of bug you encounter, you may need to redo a lot of testing, but it may also be a minor issue that is easily resolved. A large part of that decision, when it comes to software, comes down to whether you have employed a robust development method with a good design of the software (good meaning an efficient documented process flow, separated modules, followed the Good Coding Standards etc.). If you have done that, then the decision on how to handle any deviations should be fairly easy.
Hi Wnd54 and welcome to the cove.
In my opinion there is not a lot of difference between a software validation and a process validation in this respect. In validations you encounter bugs, obstacles, unforeseen events etc. What matters is whether you document them properly (raise a deviation), handle them in structured manner , and evaluate them objectively and consider the risk for the patients. Depending on the type of bug you encounter, you may need to redo a lot of testing, but it may also be a minor issue that is easily resolved. A large part of that decision, when it comes to software, comes down to whether you have employed a robust development method with a good design of the software (good meaning an efficient documented process flow, separated modules, followed the Good Coding Standards etc.). If you have done that, then the decision on how to handle any deviations should be fairly easy.