Release Date: September 22, 2023

The following applications may have different release dates: RegulatoryOne, Safety, and Veeva Claims.


This release includes fixes for the following issues:

Last Updated: November 7, 2023

Brand & Medical Portal

Description Issue No.
In some cases, Portal content viewed using Quick Look is not displayed correctly.   DEV-598778

Clinical Operations

Description Issue No.
In some cases, Clinical Activity records created in CRM fail to transfer to Clinical Operations Vaults and users encounter a Connection Error.   DEV-593678
Document versions that do not have a unique document version ID may not transfer correctly.   DEV-605048
When the Enable Study Selector Platform Integration setting is On and users delete a Study record selected in the Study Selector and then navigate back to the Library, the Study Selector displays "All Studies" selected but does not display any record belonging to any Study in the Library.   DEV-605171
In some cases, when the Yuzu Global Change Log Job is run, Vault fails to create the expected Join records for CTN and CTN Data Change Log.   DEV-605466
Users are not able to create more than 5000 EDL Items at once when creating a milestone using milestone template automation.   DEV-607076
If a user selects a Study from the Study Selector, then selects a different Study from the TMF Homepage, and then selects a custom object page list, the page loads continually and never displays any records.   DEV-610992
In some cases, Vault does not correctly populate the Study value in the Study Selector based on the URL on the Site User Home Page.   DEV-610995
In some cases, Vault incorrectly displays the Study Selector section on the Business Admin Object list page.   DEV-611025
Running the Document QC workflow action results in an error if there is only a Metadata Extraction model deployed.   DEV-612715
When the Enable Study Selector Platform Integration setting is On, users cannot access Binders and may encounter an error when attempting to do so in certain cases.   DEV-612836
In cases where over 250 records are referenced in an object reference field on a document, TMF Transfer may fail to populate the field properly on the target document.   DEV-615345
In some cases, users may encounter an ambiguous error message regarding the Last Successful Run Date when running the Clinical Operations to CDMS Connection.   DEV-617281
In some cases, certain Distribution Tasks may display that they are still in the Sending state, despite having already been sent.   DEV-617489
The Clinical Operations to CDMS Vault Connection outbound message job may remain in the "Queued" state longer than expected.   DEV-618223
Users may encounter a server error when attempting to view Trip Report Questions that include a Controlling Question with an empty Answer Set.   DEV-619847
In certain cases, when users attempt to create a Survey record for an Outreach target, Vault does not create the Survey and displays an error on the Notification page.   DEV-624775

Commercial

Description Issue No.
While generating multiple eCTD Compliance Packages, Vault hid UI navigation tabs until the user clicked a button.   DEV-612427
Uploading a thumbnail to a Veeva Distribution Package may take longer than expected or result in failure.   DEV-615327
While creating a custom tab based on document type, users are unable to select eCTD document types.   DEV-620226

Developer Features: MDL

Description Issue No.
RECREATE fails on a locked object with a document reference field.   DEV-584914

Platform: Admin

Description Issue No.
When creating a user, the Vault Object REST APIs and the Vault Users UI does not audit the application license field assignment.   DEV-530523
When configuring Auto Managed groups, Admins encounter an error when selecting the Allow selection in configurations setting.   DEV-616280

Platform: Documents

Description Issue No.
In some cases, annotations become missing from documents downloaded with the Export PDF with Annotations option.   DEV-503580
Re-rendering a document after deleting its viewable rendition may result in annotations from the deleted rendition reappearing.   DEV-554360
In some cases, when creating a Crosslink, the viewable rendition does not display for several hours.Vault creates the Crosslink as a placeholder until the rendition is available.   DEV-589285
In some cases, Microsoft Word documents may fail to render with the correct font.   DEV-607079
In some cases, if an XML file is submitted for rendering, the render process becomes stuck for an indefinite amount of time and the file is never rendered.   DEV-607674
When a Word document with a template is submitted for rendering, Vault fails to render the document.   DEV-609399
Crosslinks may fail to generate a viewable rendition while successfully fetching document metadata from their source.   DEV-611017
Archived documents do not participate in expiry behavior.   DEV-611733
In some cases, users are unable to move Anchor or Link annotations.   DEV-612718
When using the Send as Link dialog for a document, users may observe that clicking the Add Recipients dropdown temporarily increases the height of the dialog.   DEV-612957
When a classified document is reclassified, the Artifacts field updates to the new value in the Doc Info panel, but remains the previous value in other areas of Vault   DEV-614303
Lifecycle stage colors may not display for old documents that don't have the Lifecycle State Stage ID and Lifecycle Stage fields populated.   DEV-617530
Vault may create an additional record when a crosslinked document is upversioned in the source Vault.   DEV-617933
In some cases, users may see additional characters in some bookmark names within Vault.   DEV-618250
While moving an anchor annotation, the resulting pagemark is yellow instead of grey.   DEV-618681
When Create New Version is used on a document with an animated image source file, and the new version created is not also an animated image, users encounter an “error transcoding video” error message.   DEV-620010
In some cases, Vault may fail to ignore superscripts when running Suggest Links on renditions.   DEV-623010

Platform: Lifecycle & Workflow

Description Issue No.
Selecting options in one participant control may unexpectedly result in the selection of options for another participant control.   DEV-591858
Vault allows the deletion of object types that are currently associated with active lifecycles.   DEV-612199
When using the "Set field using formula" entry action, Vault may set the field value based on previous field values.   DEV-613680
In rare cases, an entry action may not trigger when a record enters the appropriate state.  This is no longer classified as a fix. DEV-615713
Vault may take longer than expected to load the Override Rules page for a particular lifecycle.   DEV-616256
Users may encounter a server error when completing a task preceding a Cancel Workflow entry action.   DEV-616385
Adding a single record workflow to a Cancel Workflow entry action may convert it to a multi-record workflow.   DEV-623685

Platform: Objects

Description Issue No.
When sharing views from the object record list page, Vault returns no results when a user enters a complete user name in the Recipients field.   DEV-611332
Under certain conditions, Vault displays a server error when creating a record on object that has Show Lifecycle Stages enabled.   DEV-611730
Inline editing text fields on object records results in duplicate input for Chrome users with Japanese Mac keyboards.   DEV-612013
Under certain conditions, users are unable to save Page Layout Rules using previously valid expressions.   DEV-613818
Under certain conditions, marking a field as required results in an server error on save.   DEV-614867
Vault removes filters applied to saved views on object record list pages when a user reorders columns.   DEV-615717
Under certain conditions, picklist fields on objects records are not copied when creating a copy of an object record.   DEV-616422

Platform: Performance & UI

Description Issue No.
In rare cases, Vault Loader may execute a job twice, resulting in duplicate records.   DEV-561627
Vault may fail to generate a signature page through entry action.   DEV-610854
Extracting the list of domain users has poor performance.   DEV-618006

Platform: Reporting

Description Issue No.
Running reports of the Workflow with Reporting Object type may result in a server error when grouping by a DateTime field.   DEV-605795
In some cases, dashboards including multi-pass reports may show the incorrect values on the Dashboard Viewer page.   DEV-609200
In some cases, when a user runs a report with object reference fields, Vault encounters a server error.   DEV-612170
If a user copies and pastes a user name or object name into the Filters field on a report, they will receive an error after running the report.   DEV-615210
In some cases, users encounter a server error when running a MultiPass report that uses an object reference field to join multiple reports.   DEV-619312
In some cases, Vault fails to load some dashboard components when the Record Count metric is used or the Sort By field specifies a different field from the Group By field in the underlying report.   DEV-620855

Platform: Search & Filter

Description Issue No.
When a user attempts to run Enhanced Suggest Links on a document that has multiple matching texts, the resulting annotation links may not cover the right text elements.   DEV-544705
Users may receive a page not found error after selecting Show in Tab on a saved view.   DEV-606168
Users may receive an error when attempting to export a view with search criteria to Excel.   DEV-607025
Users may be unable to edit search collections on smaller screens.   DEV-610773
The All Languages pill may not be saved correctly when creating or updating a saved view.   DEV-612784
Under certain circumstances, users may receive a server error while attempting to perform a document search.   DEV-620935
After performing a search that returns no results, the Learn more link is incorrect and results in an error.   DEV-621381

Platform: Security

Description Issue No.
During record creation, atomic security does not honor the owner role permissions on Object Controls.   DEV-612852
Under certain conditions, editing a user's security profile causes a server error.   DEV-613921

Quality

Description Issue No.
In Vault LIMS, the system may display inconsistent error messages in cases where the user is updating text result and numeric result fields of a Result record in the Complete state at the same time.   DEV-569428
In Vault LIMS cross-test variables may incorrectly be able to point to Test Definition Results in the same Test Definition as the calculated result.   DEV-605577
In some cases in Vault Product Surveillance, the system may fail to display a truncation warning for the Contact Info field.   DEV-610470
In some cases in the QRM Risk Builder tool, Vault may display an error message when attempting to save Risk in the grid.   DEV-611827
In Vault LIMS, users with Edit permissions for a Test when it is in the In Progress state may not be able to begin the Test.   DEV-612914
In Vault LIMS, the test execution interface may not display the Expected Amount input value as expected.   DEV-613162
In some cases in Vault LIMS, Lab Analyst users may not be able to save results in a test.   DEV-613372
In some cases in Vault LIMS, users may be unable to add Tests from different Spec Executions to a single Test Set.   DEV-613981
In Validation Management, the Executor field label may misaligned in the Test Authoring interface.   DEV-614436
Vault Validation Management displays a server error when a user attempts to delete or replace an attachment on a completed Execution Step during the test step change process when both action security is enabled for attachments and atomic security permissions to delete and upload attachments are not configured to execute in the lifecycle state.   DEV-615360
In Vault LIMS, Calculated Results may not recalculate automatically if a referenced result changes in a different test step.   DEV-615523
In Validation Management, the Delete Record dialog may display multiple times after repeatedly clicking on the delete icon in a test step in the Test Authoring Interface.   DEV-615999
In Validation Management, the Test Protocol review interface may not properly display the counts of Test Steps.   DEV-619621
In Vault LIMS, the Test Execution interface may not display results for a manually-created additional Test if there is no Sample on the Test.   DEV-621606
In some cases in Vault LIMS, calculations including datetime values may not resolve as expected.   DEV-623792

QualityOne

Description Issue No.
In some cases, Vault fails to generate a new Record Matching Rule record when the Create and Activate External Collaborator action is triggered.   DEV-613349
In some cases, reviewing saved answers on an Audit Checklist will trigger an incorrect warning.   DEV-616883

Regulatory

Description Issue No.
In some cases, Vault does not publish links when the target document does not have a Viewable Rendition.   DEV-558009
Vault incorrectly reports Rule 5040 as failed if Vault annotation links are added during continuous publishing.   DEV-579772
When the “Show inactive Applications and Submissions in Viewer” Submissions Archive Application Setting is disabled, users cannot filter by inactive Submissions, however Vault still displays inactive Submission data in the viewer grid.   DEV-594285
In some cases, small submission binders may end up in an inconsistent state where index.xml exists, but the md5 file is left as a placeholder.   DEV-599564
When transferring Content Plan data from a PromoMats Vault to a connected RIM Vault where the Content Plan does not exist, Vault does not create a corresponding User Exception Message record with the described error.   DEV-605288
Leaf hovercards within the Set Reference Leaf dialog do not properly display if the leaf Name is greater than 200 characters.   DEV-606419
In some cases, Vault incorrectly reports US Rule 7 as failed.   DEV-608930
In some cases, the RIM to Promomats Vault Connection creates and deletes Submission records without generating a User Exception Message.   DEV-609026
Vault incorrectly reports Rule 5202 as failed if a merged document contains Vault annotation or embedded links.   DEV-610882
Vault incorrectly reports Rule 5205 as failed if a merged document contains Vault annotation or embedded links.   DEV-611099
When a user merges a content plan, Vault completes the merge but does not update the Dossier Status to Publishing Inactive.   DEV-611223
Vault does not report Rule 2002 as failed when STF XML includes errors which should fail.   DEV-611754
When a new User Exception Message for an inbound document processing error is generated via the RIM to Clinical Operations Vault Connection, Vault does not does not deactivate previous UEMs in RIM.   DEV-612656
The RIM to Clinical Operations Vault Connection Document Integration job fails in RIM without a message processing error if a previous User Exception Item contains an empty Item Data field.   DEV-612669
When the RIM to Clinical Operations Vault Connection integration is re-run after an inactive Country is added in Clinical, the RIM Vault generates an Inbound Documents - Message Processing Error instead of an Item Processing Error.   DEV-612907
During continuous publishing, Vault does not report Rule 1323 as failed when there is a published placeholder.   DEV-613342
Vault does not populate the Published by Vault field when on-demand publishing a document with a link.   DEV-613870
Vault exports Application-level Correspondence documents when they are hidden from the Export view and the Dossier Status is Publishing Active.   DEV-614082
Vault does not report Rule 11.12 as failed when a leaf is deleted or replaced by more than one node.   DEV-614169
Vault does not update the Published by Vault field when publishing a reference leaf via continuous publishing.   DEV-614526
The Learn More link from the Training Summary Results field within Trained Model records incorrectly resolves to the Clinical Vault Help page for the TMF Bot (page ID: 72739). The link should resolve to the Regulatory Vault Help page, Evaluating RIM Bot Auto-Classification Models (ID: 518092).   DEV-615638
In some cases, Vault displays a server error when users initiate the Direct Approval Workflow for Binder VV-SUB-00007.   DEV-618557
When a user navigates to another Application from the Submissions Archive Viewer, the viewer does not respect applied column filters.   DEV-619062
In some cases, previously matched documents that should be filtered out are incorrectly auto-matched to EDL items.   DEV-620646
When Global to Local Submission Type Mapping is enabled, users are able to navigate to the bulk creation wizard’s Additional Details page without selecting a Submission Type.   DEV-625069
Users cannot start the registration data verification workflow for multiple records when the “Automatically name envelope records” workflow setting is enabled.   DEV-625072
The filter UI in the Submissions Archive Viewer may become unstable and difficult to use when there is a large number of selections.   DEV-625079

RegulatoryOne

The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on October 3, 2023.

Description Issue No.
In some cases, icon images don't display as expected in the Registration Item Requirement Viewer.   OLS-22124

Safety

The Safety release, including all Platform fixed issues, is targeted for tentative availability on September 28, 2023.

Description Issue No.
In some instances, merging Inbox Items to domestic Follow-up Cases through the Case Compare page fails.   SAF-34349
When values in an E2B file map to inactive records, E2B import fails.   SAF-36203
When creating Follow-Up Cases, Expectedness values from initial Cases are changed on the Assessments and Case Assessment Expectedness sections of Follow-Up Cases.   SAF-40548
When an Inbox Item is saved immediately after updating its New Info Date, the date does not appear in the New Info Date column of the Inbox Item Inbox, although the date has been saved.   SAF-42184
For E2B-imported Inbox Items, the primary Case Product is not included in Case names.   SAF-44090
When an E2B file does not include both values and units for First Dose Latency and Last Dose Latency, none of the data elements are imported and the related Case Assessments are not generated.   SAF-44214
When the primary Product is changed on a Study Case for an open-label Study with Unspecified Products, the Case name is not updated.   SAF-44392
When a foreign Localized Study Case includes Substance records but no Transmissions, changing the Case Study Product on Follow-up Cases is prevented.   SAF-45867
Case Access Group security rules are not applied to the Local Reporting Details and Local Reporting Details/Product Join objects.   SAF-45868
When using Case Access Group security, manually created Parent Cases do not inherit Access Groups from Child Cases.   SAF-46052
When using Case Access Group security, Case role assignment does not consider the Localization set on the User Access Group Assignment record.   SAF-46088
When a case narrative is updated, the narrative preview and generated XML file do not reflect these changes.   SAF-46100
The "Product" Reporting Rule Parameter does not evaluate whether Cases contain Company Products.   SAF-46175
When generating Individual Case Safety Reports (ICSRs), exporting multiple Device Follow-Up Type values for a single device is supported. On FDA MedWatch 3500A reports, multiple checkboxes can be selected in the H2 If Follow Up, What Type? field. On VAERS E2B(R3) reports, the FDA.G.k.12.r.2.r If follow-up, what type? data element repeats for each selected follow-up type. On FDA E2B(R2) reports, multiple B.4.k.20.FDA.18.1 data elements can be set to 1. Support for this feature requires configuring the new Device Follow-Up Type field. For more information, contact Veeva Support.   SAF-46262
When generating PMDA E2B(R3) reports, if the Case Product Dosage Route of Administration field is set to Unknown, the G.k.4.r.10.1 Route of Administration data element tag is incomplete and the G.k.4.r.10.2a Route of Administration TermID Version Date / Number and G.k.4.r.10.2b Route of Administration TermID data elements are exported although they should not be.   SAF-46318
When creating CIOMS II reports, if a Study in the Reporting Family includes a Case where the primary Product has a Drug Role other than Suspect or Interacting, an error occurs and the report does not generate.   SAF-46498
Entering multiple values in the Device Follow-Up Type field is now supported. For more information, contact Veeva Support.   SAF-46546
In some instances, there is no break between paragraphs when viewing Company Comments and Reporter's Comments in the Show More Text window.   SAF-46699
PMDA.J2.2.2 fails and causes a validation error even in Follow-up cases.   SAF-46710
When a non-Admin user clears the Country field on an Inbox Item, the field is not automatically cleared in the Case Validity and Source section.   SAF-46737
Submissions are prevented when a single Reporting Rule is overridden by multiple Rules within another Rule Set.   SAF-46771
Values entered in the Source field are mapped to the Localized Source field upon case promotion even when the "Enable Localization-based Mapping on Import" setting is turned off.   SAF-46772
When processing a Pregnancy Case, if the Gestation field includes a zero (0) in the numeric field and a unit of measurement is selected, clicking Save does not save the Case details.   SAF-46962
Safety Rule Configuration Reports do not correctly apply more than two levels of inheritance.   SAF-47048
Safety Rule Set Configuration Reports do not include Rule Set Parameters for inherited Rules.   SAF-47082
When Case Access Group security is enabled, a server error occurs when attempting to view Cases if the user does not have Read permission on hidden fields in the Drug History section.   SAF-47130
One Last Time (OLT) reporting is prevented if a previous Case version includes an inactive Transmission Profile or Organization.   SAF-47329
Headers from Narrative documents are appearing in generated ICSRs, resulting in non-compliant Transmissions.   SAF-48093

Site Vault

Description Issue No.
Under certain conditions, document creation in Site Vault fails.   DEV-613637

Veeva Claims

The Veeva Claims release, including all Platform fixed issues, is targeted for tentative availability on October 3, 2023.

Description Issue No.
Clicking Back to Previous Page after running the Remove Statement and Related Records action on a Project record's details page does not return users to the details page.   OLS-21972
The related record sections on substantiation documents and the Remove Statement and Related Records from Project page provide the option to Freeze Column, which is not required for these record grids.   OLS-22264