What’s New in 25.8.1
What’s New in 25.8.1
Manage links in Publish (browser based) (SB-5707)
Benefits:
Easily manage and customize links within the software
Efficient link processing capabilities making Publish the go-to tool
Features:
Create links within the same file
Create links to other files within the application
Edit existing links
Delete links as needed
Customize link border and text colors
View link counts for processed PDFs
Support of AU 3.2 regional eCTD updates (SB-8614)
Benefits:
Access latest changes for AU 3.2
Features:
Create an AU 3.2 regional update application
Publish and Review an AU 3.2 application
View sections and metadata as per 3.2 guidance
Support of AU 3.2 Validation updates (SB-8649)
Benefits:
Access to the latest errors (per agency)
Features:
View AU error codes 1.1, 2.2, 2.7, 2.8, 4.2.1, 4.2.13
Note: This is a partial Validation update for AU 3.2. Additional changes will occur in upcoming releases.
Updates to Japan 4.0 (per regional guidance) (SB-8653, SB-9568, SB-9177, SB-9480)
Benefits:
Greater flexibility with additional choices based on the values entered for Japan 4.0
Features:
Support of multiple products with multiple substances
Publish ICH 1.6 for Japan 4.0
Reception number is the primary number with the Application number now optional in the wizard.
Publish “Only study data” submissions, leaving out metadata (Organization, Product, and Substance) not required by the agency for the submission type.
Updates to Study output folders for FDA and Japan 4.0 (SB-9092)
Benefits:
Receive Study folder outputs for Japan and FDA 4.0 without extra steps
Features:
Add files to Document types with specific dataset folders.
View the folder structure in Edit, tree, and output.
Customize multi-level folders to meet user and agency requirements
Updates to FDA and Japan 4.0 to support Document Label (SB-8652)
Benefits:
Easily link document labels to a file or group of files based on agency guidelines
Features:
Add and associate files with a document label.
Edit document labels.
Delete document labels.
View XPT files in preview pane (SB-8836)
Benefits:
Access XPT contents in the preview pane within the software
Features:
View XPT files in Review, Publish, and Desktop products
Issues Corrected in GlobalSubmit 25.8.1
Issues Corrected in GlobalSubmit 25.8.1
GlobalSubmit Load PDF processing is no longer skipped when application is processed (SB-6017).
GlobalSubmit Load In Configuration tab, “Allow Sequence Reload” option is now functioning (SB-9220).
GlobalSubmit Publish (browser) Cross-reference applications get output with correct XML tags (SB-9383): The XML tag has been updated in the output for Japan 4.0 applications when multiple applications are cross-referenced.
GlobalSubmit Publish (browser) Priority numbers are now unique for sections across multiple submission unit(s) in FDA and Japan 4.0 (SB-9647): For sections used across multiple submission-units, a unique priority number is now assigned.
GlobalSubmit Review (browser) View Details gives an error when cross reference application exists in an application (SB-9136): For applications with cross reference applications, View Details now works without error.
GlobalSubmit Review (browser) View Details gives an error when submission-unit number is greater than 1000 (SB-9170): For submission-unit(s) with number greater than 1000, View Details will now work without error.
GlobalSubmit Publish and Review (browser) Sort currently does not work in Publish and Review on the columns in the grid (SB-9536): Sort now functions on columns for Publish and Review grid.