Validation and Compliance: Software Systems Prepare Manufacturers for Com(PAT)ibility

Few people really understand how software works, but everyone notices when it doesn’t, especially when these systems contain the data that will be used to determine product quality and ensure regulatory compliance. Industrial-scale software implementation is a considerable investment, and the technology that drives it advances quickly. Thus, it was not surprising that when FDA announced its support of the process analytical technology (PAT) approach to pharmaceutical manufacturing, questions arose about how current software systems would have to be modified.

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