Known Issues

The following general issues and module-specific issues were known at the time this document was published, but (due to time limitations) could not be included in the module-specific user documentation packaged with the software product.

Ennov InSight : Common

Issue Affected Area Description
240123 (Added on 9th April, 2024) Assembly When using the Prepare Cross Reference Leafs option, if there are multiple reference leafs pointing to the same target leaf, the checksum value is generated for one leaf only.
DE32002 (Added on the 29th of August, 2024) Assembly After assigning a document on folder from SMB, the PDF Exists value of the document is not set to Yes.
DE31898 (Added on the 28th of August, 2024) Reference Links If a Documentum folder has two documents with the same name and one of these documents have more than one version, creating a reference to this document results in the reference created to the document with only one version.
DE31882 (Added on the 29th of August, 2024) Assembly

Trying to rename a document previously assigned to an assembly results in a new name

not being displayed in the leaf after a document is reassigned.

DE30194 Entity History Trail After deleting an entity, the Entity Audit Trail query displays only a row with D (Delete) action instead of both U (Update) and D (Delete) rows. Details about performed action are now displayed in D (Delete) row.
DE29212 (Added on the 23rd of January, 2023) Application, Product, Product Family When performing the API Post request, an application that does not have a product is not created under a product family. Workaround: use override updates to fix this issue.

DE28641 (Added on the 20th of October, 2022)

Application, Products When all the products are disassociated on the Application Attributes page, the system allows disassociation. No warning messages informing that at least one product should be associated to the application is displayed.

DE27749 (Added on the 19th of April, 2022)

Application, Country

For individual users, when the Application Country Rights for Product Families is set to All and Countries is set to any rights, navigating to a county from the Application Attributes > Countries tab results in an error.

Workaround: Set the Application Country Rights for Product Families and Countries to

All .

DE29739 Application, Product Family, Create Submission wizard

The Create Submission wizard does not work for applications without products when selecting Major Update or Amendment options. When it is opened from:

— the Application Attributes page, the error message is displayed.

— any other pages, for example: Home > Wizards > Create Submission, the applications with products can be only selected.

DE27309 (Added on the 12th of January, 2022)

Update Product Details Sets, PDS, Substance

When you select Global Project Plan > Modify

Substance or Add Substance from Project

Attributes page for the Update Product Details Sets project type, not all the fields are displayed in comparison to the Substance page in PDS.

26814 Publishing

Using Prepare for Publishing with the Prepare Cross Reference Leafs option selected results

in the Unable to extract checksum error

if there is a reference leaf to leaf published to

Documentum.

26807 (Added on 20th Aug 2021)

Assembly When updating a leaf in an assembly, selecting OnLoad for the Actuate option results in an error message. This is because of the default security settings. Workaround: Update the leaf using API.
26799 eCTD Import

After you use the Bulk eCTD Import for TW submission, the Job Status is set to Scheduled instead of Completed. This is because the twregional.xml file does not contain the application code.

Workaround: Use Import eCTD to Application instead of Bulk eCTD Import. See: Import eCTD to Application.

26728 Global Project Plan wizard, PDS In the Global Project Plan wizard, when modifying an active ingredient for a PDS the Withdraw Material that is already selected is not shown in the drop-down list.
26699 Assembly

Ennov InSight can incorrectly send a

Native .PDF file to Ennov InSight Rendering for extraction. Also, while a large file can fail extraction, it might not prevent successful publishing.

26637;

[INC0045216]

Administration In Data Administration, the Check for Datebased Notifications menu is not available on the Notification Specifications grid.

Ennov InSight Publisher

Issue Affected Area Description

DE32388 (Added on the 21st of January, 2025)

Publishing eCTD 4.0: Working assemblies are not displayed in the Quick Search results.

DE32365 (Added on 7th of December, 2024)

Publishing After creating an assembly from an EU 3.1 assembly that is exported, the Submission Type and Submission Unit Type envelope values are not displayed.

DE32346 (Added on 19th of December, 2024)

Publishing When importing an eCTD application having leafs with Replace, Append, and Withdraw lifecycle operation performed on them, the values for the following may be missing: Language, Application Version, Version, Font Library, Role, Actuate, and Show.

DE32056 (Added on 20th of September, 2024)

Assembly Performance issue is experienced when using the Insert Volume functionality.
DE31961 (Added on the 21st of August, 2024) Assembly

When a document is assigned from the Secure

File System and then the Extract Document Data job is performed, editing the document from the Secure File System and performing the DMS Synchronization results in the creation of two Extract Document Data jobs.

DE31940 (Added on the 16th of August, 2024) Assembly

Searching for a document to assign using Build Query results in an error.

Workaround: Form a search request without Build Query option.

DE31934 (Added on the 14th of August, 2024) Assembly

After the subsequent volume is inserted into the assembly folder or deleted, the previous volume name changes to the default one.

Workaround: Update volume names manually.

DE31925 (Added on the 28th of August, 2024) Create eCTD wizard

It takes longer than expected to create a 1.1.5 folder using the Create eCTD wizard.

Workaround: Create a folder manually or wait for a wizard to complete the folder creation.

DE31470 Publishing eCTD 4.0: After submitting the publish request with All Leaf Elements and XML options selected, the Publish Request window fails to close.

DE30999 (Added on the 27th of November, 2023)

Assembly

eCTD 4.0: After a CV Profile is removed from the Edit Publishing Settings > CV Profiles > Selected section, some of the Sender-defined

Keyword values are not displayed on the Additional Information page in the assembly folder.

Expected: All fields are displayed on the Additional Information page.

The change of CV Profiles for the existing assembly is not supported.

DE30247 Assembly

After exporting an assembly to XML file,

Default Overlay For field does not contain Documents value. Adding the same value to a new assembly created from XML file results in Invalid Reference error.

DE29906 Assembly

In the Working eCTD 4.0 assembly, when a duplicate folder or a reference leaf is created, the Document ID field fails to inherit the value in the duplicate reference leaf.

Workaround: After a duplicate reference leaf is created, recreate it by using the option Convert

to Default Leaf first and then Convert to Reference Leaf.

DE29855 (Added on the 22th of May, 2023) Assembly After re-running the Refresh Tree operation, sequence assembly structure does not update. Workaround: Log out from your user account and log on again.
DE29521 (Added on the 23th of March, 2023) Assembly

In an assembly, the username format displayed when changing the user in the Owner field is incorrect. Instead of

[email protected], firstname.lastname is displayed.

DE28539 (Added on the 28th of September, 2022)

Assembly

Operations with eCTD 4.0 assembly can fail if their processing time exceeds four minutes.

Workaround: In the assembly created, reduce the number of operated nodes to make the processing time faster.

DE27966 (Added on the 1st of June, 2022)

Assembly

The published output files are not exported to Documentum repository if they have Chinese characters in the file name.

Workaround: rename files as per eCTD normalization rules before exporting output.

DE27958 (Added on 1st of June, 2022)

Assembly

After publishing the China assembly, China symbols are present in the name of the STF

file. For example: stf- 4.2.1.1 药效学.xml

Workaround: rename files as per eCTD normalization rules before exporting output.

DE27442 (Added on the 9th of February, 2022)

Assembly eCTD 4.0: After clicking Lock or Unlock on an assembly folder or an assembly root, the Throbber icon used to indicate an action in progress does not appear and all the folder or assembly elements remain enabled.

20270;

[136797FW]

Assembly Links for External Bookmarks are incorrect for split documents in paper published output.
DE32383 (Added on the 16th of January, 2024) Data Administrator If the Display Name exceeds 1000 characters, it is not possible to create and update Senderdefined Keyword Value.

Ennov InSight Registrations

Issue Affected Area Description
DE31108 (Added on the 10th of January, 2024) Substance, Pharmaceutical Product

On the Medicinal Product Attributes >

Pharmaceutical Products tab, the

Pharmaceutical Product Summary column displays the Range value from Concentration Measure Type and does not show all the reference active ingredients.

The column should display all the reference active ingredients while hiding the Range value.

Ennov InSight Outlook add-in

Issue Affected Area Description
DE26820 Outlook add-in form

You cannot attach the following items from an e-mail in the add-in forms: — Contact - .vcf

— Calendar (Event) - .ics

— Outlook e-mails - e-mails without an extension (e-mail chain, single e-mail, and composed e-mail)

DE26804 Outlook add-in form

When using the API GET request for retrieving the recipients from Microsoft Graph, if the search criteria contains a space, the following error is shown: 500 Internal Server

Error

DE26803 Outlook add-in form In the Add Notification Recipients field, it is not possible to delete any spaces.
DE26782 Outlook add-in form If more than 50 users try to submit a form, the system fails and an error is displayed.
DE26781 Outlook add-in form When an API request with invalid product id is sent for CreateSubmissionAndReference, an incorrect error message is displayed.
DE26738 Outlook add-in form If Ennov InSight Outlook add-in fails to submit the forms, an incorrect error message is displayed.
DE26731 Outlook add-in form

An auto-populate functionality does not work for the Product field in the Ennov InSight Outlook add-in forms if the product name starts with an article. Example: "The Product

01", "A Product 123"

In the Ennov InSight Outlook add-in forms, the auto populate does not work for product unless more than 3 characters are typed.

DE26715 Tool Box and Activity History When using the Ennov InSight Outlook add-in desktop version on Windows 10, version 2004 and Outlook version 1908, it is not possible to click the Export button on the Activity History Analysis page.
DE26711 Add-in meta overrides Trying to change the Ennov InSight Outlook add-in icon takes longer time than expected.
DE26704 Outlook add-in form Empty text files cannot be attached using the Browse File button.
DE26703 Add-in meta overrides In the Ennov InSight Outlook add-in desktop version, even after restarting the Microsoft 365 Outlook, the system fails to override the "Liquent InSight" launch icon.
DE26702 Outlook add-in form

When trying to attach the files for the Ennov InSight Outlook add-in forms, ToolTips are not displayed for the following:

— Attach from email button

— Browse files button

— "No available items to attach"

ToolTip when all the attachments are already attached

Ennov InSight Rendering

Issue Affected Area Description

DE26968

(Added on the

23rd of

December, 2021)

Assembly

The assembly files cannot be published to Documentum if their size is 800 mb and more. The distribute job request fails.

Workaround: Ensure that the size of the assembly files is less than 800 mb.

DE28324;

[TASK0043134,

INC0109855]

(Added on the

12th of August,

2022)

Assembly Publishing to some printers may result in tab text misplacement.
DE26794 Assembly When eCTD assembly is published, the validation messages from the backbone generator are not displayed in Job Requests Details.