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Open Source Software in Life Science Research by M Forster, L Harland

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21

Validation and regulatory compliance of free/open source software

David Stokes

Abstract:

Open source systems offer a number of advantages, but the need to formally validate some open source applications can be a challenge where there is no clearly defined ‘software vendor’. In these cases the regulated company must assume responsibility for controlling a validated open source application that is subject to ongoing change in the wider software development community. Key to this is knowing which open source applications require validation, identifying the additional risks posed by the use of open source software and understanding how standard risk-based validation models need to be adapted for use with software that is subject to ongoing ...

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