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Can an open source system be validated?

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  • Sally Hughes
    15/05/2018 13:03
    I have recently audited a company who plan on using open source software for statistical analysis of critical clinical trials data. We spent a lot of time discussing approaches to control and testing but I have a fundamental question on whether such software can be truly considered as validated for this purpose. Does anyone have experience of this and can you point me to any guidance either for or against please? Thanks in advance!
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