Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
A straightforward path toward regulatory compliance, data integrity, and computer systems validation
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
A key theme emerging from FDA complete response letters since 2018 is that data system validation is lacking in the ...
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