Data Entry Definition FDA 
ISPE
JUNE 21, 2023
Software applications were just beginning to be deployed to capture data that supported predicate rules and regulatory submissions. The industry needed definitions and guardrails to ensure consistency and assurance that the data being captured had data integrity and the right levels of control points (i.e.,
ISPE
MAY 11, 2023
™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. Published 30 November 2018.
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