Discrepancy Between PADER Submission Date And Submitted Date In The Safety Case
(Doc ID 2807323.1)
Last updated on DECEMBER 04, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1.2 and laterInformation in this document applies to any platform.
Goal
There is an apparent a discrepancy between submission dates displayed in both a PADER output and Regulatory Report's tab for each of three cases noted below.
More specifically, a discrepancy was observed between the submission date in an Argus case and the date generated in the PADER.
In ARGUS Safety (Regulatory Report’s tab of each case):
In the PADER the 3 cases appear as submitted on 12-Dec-2019.
Could an explanation for auditors be provided?
Solution
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In this Document
Goal |
Solution |
References |