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MFDS E2B R3 Updates for Argus 8.2.2 (Doc ID 2751358.1)

Last updated on APRIL 12, 2021

Applies to:

Oracle Argus Safety - Version 8.2.2 to 8.2.3 [Release 8.2]
Oracle Argus Interchange - Version 8.2.2 to 8.2.3 [Release 8.2]
Information in this document applies to any platform.

Purpose

Revision History
Date Description
12-Feb-2021 Published
19-Mar-2021

Added SQL queries for below sections

8.2.3 updates in Mappings

8.2.3 updates in Validations

Updated section 8.2.3 bug fixes related to MFDS E2B R3 with details of workaround
01-Apr-2021
  1. Corrected Validation message (J) for 5 PATIENTSEXR3
  2. Added column “Mapping logic update as per Business rules published on 16-Mar-21” in section “8.2.3 updates in Mappings” and corresponding SQL query
  3. Added column “Update as per Business rules published on 16-Mar-21” in section “8.2.3 updates in Validations” and corresponding SQL query
  4. Added column “XSLT update based on Agency testing” in section “8.2.3 updates in XSLT” and corresponding steps to update XSLT

 

The mandatory date for E2B R3 submissions to MFDS South Korea is 1-Jun-2021.

 

Purpose of this article is to share the list of updates that need to be applied on top of Argus 8.2.2 for customers planning to use Argus version 8.2.2 for E2B R3 submission to MFDS.

Note that these updates are being implemented in Argus 8.2.3 and will be available as out-of-the-box.

 

On 16-Mar-2021, MFDS published updated business rules in their website. The updates are not part of 8.2.3 since it was late for implementing in 8.2.3 which was released on 5-Apr-2021

Purpose of this article is to share the list of updates that need to be applied on top of Argus 8.2.3 for customers planning to use Argus version 8.2.3 for E2B R3 submission to MFDS.

Scope

This document applies to Argus version 8.2.2 to Argus 8.2.3.

 

 

Details

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In this Document
Purpose
Scope
Details
 Introduction
 MFDS E2B R3 Updates After 8.2.2 Release
 Revisions after 8.2.3 release
 8.2.3 Updates in Mappings (differences are in red)
 SQL Queries
 Updates in Validations (differences are in red)
 SQL Queries 2
 Updates in XSLT
 XLT Updates
 8.2.3 Bug Fixes Related to MFDS E2B R3
References

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