Setting the tone for CSA

CSA thinking is in the anvil for quite some time, with US FDA reaching out to industry veterans. FDA launched the Case for Quality initiative in 2011 for a case to promote automated solutions as opposed to prevalent and outdated software. With its roots in the Medical Device industry, FDA’s aim was to improve quality with a focus on identifying areas related to high-risk requirements and reducing or combining the non-value adding requirements. The assessment was based on software’s impact to public health, patient safety and quality system-and-data integrity. CSA is not a fad, hyperbole, or a recent quality trend but meant to be a way of life to make existing processes and efforts needed to implement those processes, simpler and less resource intensive.

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