“Computer System Validation” (CSV) has remained mostly unchanged for the past two decades. General Principles of Software Validation (GPSV), issued by the FDA in 2002, has been and continues to be the primary tool industry uses as guidance on this topic. CSV, as it stands today, is a documentation heavy exercise Documentation is done at […]
There are two parts to this webinar: 1) CSA and data integrity GPG DI alignment; and, (2) Insert more data integrity so we don’t bore people with CSAHear directly from the source, FDA – Industry CSA Team & Colleagues in a Panel setting discussing the upcoming ISPE GAMP Good Practice Guide (GPG) Data Integrity (DI) […]
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