- May 10, 2021
- Posted by: Techsol Life Sciences
- Category: Drug Safety
Key Highlights of the Latest Oracle Argus v8.2.3 Release and Why Its Important for Drug Safety Processes
by Sriram Varma on May 10, 2021
In April 2021, Oracle released the new version 8.2.3 that addresses new regulatory compliance requirements, several functional enhancements, enhanced user experience and critical technology updates for the Argus Safety and Argus Insight suite of drug safety applications. Oracle Argus Safety is a multi-vigilance platform that enable collection, assessment and reporting of adverse event cases originating in pre-post-market drugs, biologics, vaccines, devices, and combination products.
Let us take a closer look at some of the major areas that are being upgraded as part of this release.
Regulatory Compliance Updates
To address key regulatory requirements, Oracle has introduced the following updates in this release.
CDRH eMDR Updates
The revised guidelines published for eMDR reports submission (May/ Sep 2020) from CDRH are now incorporated as configurations with changes introduced in the Console, Case Form, and Interchange mapping. There are new updates in the IMDRF Codes and to the general eMDR Profile.
CBER eVAERS Changes
To comply with CBER’s revised guidelines for eVAERS (June 2020), Argus Safety has several new changes to Interchange mapping & Device code mapping updates.
South Korea MFDS Related
The MFDS E2B(R3) profile has been updated with new business rules which includes new mappings and XML file reference validations. Transmission of STUDYNAME element in the Korean language for E2B(R3) submissions to MFDS is now in the local language.
Brexit Related
Post Brexit, there are new regulations in effect for ICSR Reporting to MHRA. This new version of Argus has a Code List update to include NORTHERN IRELAND as a new Country as part of EEA. Also, there are several Interchange Updates that have revised Import and Export Mapping Logic for EMA R2 and R3 Profile for country code “XI”.
EMA Related
To address the ‘Negative Acknowledgement’ problem in scenarios when there are multiple reporters, the mapping rules are now enhanced, such that reporter country is populated, even when the Protect confidentiality check box is marked. Additionally, new validation is provided to check if at least any one of the elements is present with a valid value in all the reporters included in ICSR reporter family name, organization, post code and country.
Japan Related Updates
This version supports Japan’s Ultramac dictionary for reporter and institution data. With the modern browser support, it is recommended to use wider screens when you use vertical split screen for Japanese or English view.
Cross-Browser Compatibility Support, User Interface Enhancements, and Other Functional Updates
Oracle Argus Safety has been enhanced to support the following alternate modern browsers instead of Microsoft Internet Explorer IE 11:
- Google Chrome version 84.0.4147.135 (Official Build) (64-bit)
- Microsoft Edge (Chromium based) version 84.0.522.52 (Official build) (64-bit)
With alternate browser support, users can now leverage the following capabilities:
- Spell Check: With alternate browser support, Argus web application now supports the spell check feature as supported by the browsers rather than limiting to few screens.
- Button to minimize/maximize/close: To enable user to close the pop-up screens in Oracle Argus, the Close button is added wherever it was not available. Now, you can close the window using the Close button instead of the cross button (X). Alternatively, you can you the Esc button to close the window.
The notable updates to the application user interface are:
- Auto-resizing of windows
- Display of visited link
- Oracle Argus Japan split screen
- File Display Path
- Autofill Password
- Restriction of Emoji’s usage
Additional Enhancements
Common profile switches updates, Reporter information display in code list with a large number of institutions associated, Argus Console enforces field configuration for E2B destinations and Chart option in CDA report configuration.
Argus Insight Updates
The Oracle Argus Insight menu to invoke BO and Cognos has been removed. This also includes the removal of common profile switches related to BO/ Cognos.
Additional Reading
For more detailed information about the Argus Safety v8.2.3 release, please click here to visit the official Oracle Release Documentation.
How Techsol Can Help
As a preferred and specialized Oracle Argus Partner, Techsol is actively working with several multi-national pharma companies to help them leverage the maximum potential of the Argus Application Suite by successfully completing rapid upgrades along with the required systems validation documentation. To know more about our technology services and capabilities around Argus Safety, Insight and Empirica Signal, please click here.
With our extensive experience, we have been relied as a trusted technology partner by our clients for the last 10 years. If you have any questions about this latest release or if you are seeking advisory guidance to deploy this new Argus Safety version, please feel free to contact us by sending an email to info@techsollifesciences.com.