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What is the List of Strength Units That can be Selected in the Product Information or Lab Tests Units Screen for MFDS profile ? (Doc ID 2851912.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.3 and later
Information in this document applies to any platform.


Argus 823: STRENGTH UNIT Validation Questions

1. By selecting a STRENGTH UNIT value in the CASE FORM screen, after performing an ICSR Check receive the below warning:


Allowed Value Validation Failures" for STRENGTHNUNIT tag in ICSR check for MDFS profile

For Example:

Select Unit =  'milligram per millilitre' in Case form → Products → Substance Information → Unit section.

When performing ICSR check, getting below error,

Allowed Value Validation Failures ---- G.k.2.3.r.3b ---- STRENGTHUNIT ---- Case Form/Products/Product Information/Units ---- The data value (mg/mL) specified for the element is not an allowed ICSR Value for this profile (ICH-ICSR V3.0 MESSAGE TEMPLATE - MFDS).

This appears to be because Argus could not find the corresponding entry in CFG_M2 table for profile 'ICH-ICSR V3.0 MESSAGE TEMPLATE - MFDS' and dtd_element 'STRENGTHUNIT'.

When executing below query as Argus Schema owner, get ZERO result,

Question: What is the list of STRENGTH UNITS that can be selected in the Product Information screen for the MFDS profile?

2. Additionally able to see Lab unit, Dosage unit, Strength unit fields display all units without applying code list check box options.

For example:

Lab Units values are populating in the Strength Unit field.

Aware that this issue is fixed in Argus (via Bug 33140025) but looking for a workaround to resolve this issue in lower code versions


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