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ONADE: Improved the performance of accessing product, master file, and ADMS establishment and supply chain book information shared on a network drive by supporting local user indices (see the Alerts/News section from the "Help" menu or introduction screen messages for instructions on setting up the local index support).
All: Performed the periodic maintenance activity of moving inactive templates from the standard templates file to an archive file, thus reducing the size of the active templates file when deploying template updates.
All: Removed the requirement for CVM ESS registration of Responsible Officials/U.S. Agents as no longer necessary based on the new sponsor account management capabilities contained within the new FDA ESG NextGen. Responsible Officials/U.S. Agents will still be required to sign submissions, but they no longer will be validated against CVM ESS.
All: Updated the "Getting Started" dialog for new users to represent the new FDA ESG NextGen capability and removal of CVM ESS registration.
Fixes
None.
Version 1.85.00
Released 2/19/2025
Enhancements
None.
Fixes
ONADE: Fixed issues related to submissions containing CMC Sterilization Process Validation information:
Inability to reference previously entered master files within sections: Sterilization of Components/Equipment by Irradiation, Terminal Sterilization of Drug Product by Irradiation, and Depyrogenation.
Loss of entered data within the run results captured under the Depyrogenation section when reloading the section.
