| Description |
Issue No. |
|
In Vaults using the Study Training to Clinical Operations Connection, CrossLinks may not render as expected if the document undergoes state changes in quick succession.
|
DEV-544944* |
|
The YUZU version of the J-CTN Word document that Vault generates does not include empty fields.
|
DEV-548728 |
|
When running the Retry Failures or Run Associated Rule action, Vault does not update the Finish Time on the Agreement Transfer record.
|
DEV-549065* |
|
The Trained Model Type field remains editable when the record is in states other than Create.
|
DEV-550235* |
|
When metadata extraction and document classification models are deployed and an Admin uploads an unclassified document, Vault does not generate prediction records for the document even though it does auto-classify it.
|
DEV-550638* |
|
In Vaults using the Study Training to Clinical Operations Connection, updates to previous versions of a document in the Clinical Operations Vault may incorrectly be applied to the latest version in the Study Training Vault.
|
DEV-551620* |
|
When attempting to edit Field Rules for the Study Person Integration Rule, Vault may display a blank page.
|
DEV-551830* |
|
In some cases, running the document extraction job results in an error, and the job fails.
|
DEV-551863* |
|
In Vaults using the Study Training to Clinical Operations Connection, failed Field Rule evaluations may not result in User Exception Messages as expected.
|
DEV-551905* |
|
When running the Load Candidate Sites action, if the CSV file name contains a space, parentheses, and/or underscores, Vault fails to upload the file.
|
DEV-552564* |
|
If users make changes to the Study field on a document but not the document classification, Vault does not update the study feedback appropriately.
|
DEV-553339* |
|
If users remove a Milestone from an EDL Item after Vault has already stamped the Milestone onto a document, Vault does not remove the Milestone from the document.
|
DEV-553404* |
|
In some cases, users are unable to delete Study records in ClinOps Vaults.
|
DEV-554100 |
|
When transferring a document from Clinical Operations to RIM, the document maybe incorrectly associated with all Products associated with its Study rather than the single Product (or no Product) with which it should be associated.
|
DEV-555420 |
|
In Vaults using the Study Training to Clinical Operations Connection, User Exception Messages may not be created if an unexpected error occurred after Vault identifies records or documents to sync.
|
DEV-555998* |
| Description |
Issue No. |
|
In rare cases, Vault may show previous viewable renditions in the Document Viewer after a new rendition has been uploaded.
|
DEV-531901 |
|
In the Advanced section of the Bring Forward Annotations dialog, Japanese, Chinese (Simplified and Traditional), and Korean error messages use full-width (non-English) instead of half-width (English) punctuation marks.
|
DEV-544554 |
|
In some cases, Vault will lag in retrieving the viewable rendition of a CrossLink document if the version is changed while the rendition is being generated.
|
DEV-545748* |
|
Vault may fail to properly render a document in a multi-document workflow if a user upversions it.
|
DEV-547438 |
|
Under certain circumstances, uploading and rendering documents with custom templates results in corrupted modified source files are corrupted.
|
DEV-548417 |
|
Vault displays an unhelpful error message when a document comment contains certain special characters.
|
DEV-549770 |
|
Users may encounter an unexpected error when attempting to check out a document for collaborative authoring in Microsoft Office.
|
DEV-550678 |
|
When naming binder sections, Vault incorrectly escapes special characters, such as ampersands.
|
DEV-550839 |
|
The "Delete minor versions" entry action does not delete binder nodes, and attempting to delete a document referenced by a deleted binder version results in a "Server having problems" error.
|
DEV-551025* |
|
When a Legal Hold record is in the Lifted state, any user can delete the document.
|
DEV-551160 |
|
When attempting to merge documents with a total number of pages greater than the page limit, Vault does not display the correct error message.
|
DEV-551528* |
|
When a user attempts to upload a source document to a placeholder with a filename longer than 218 bytes, Vault displays a "Server having problems" error instead of the expected error message.
|
DEV-552307 |
|
in some cases, users are unable to download a viewable rendition of a document without an overlay even when Allow download without overlay is selected.
|
DEV-552394* |
|
The font subsetting process fails for all fonts when at least one font in a PDF is corrupted.
|
DEV-552587* |
|
In some cases, Vault displays a server error when users attempt to navigate to the Library.
|
DEV-552630* |
|
In some cases, document attachments are not rendering in the external viewer and Vault displays an error.
|
DEV-553203 |
|
Under certain circumstances, users may be unable to see document annotations in Document View.
|
DEV-553850 |
|
If a user accesses a document while a manual rendition is still processing, the manual rendition may be lost.
|
DEV-555858 |
|
In some cases, comments made on one page of a downloaded viewable rendition are replicated across all pages of the PDF except for the first page and the signature manifestation page.
|
DEV-557107 |
|
In some cases, pages in downloaded viewable renditions appear stretched and display incorrectly.
|
DEV-558773 |
| Description |
Issue No. |
|
In some cases, users are able to use the back button in their browser after deploying configuration migration packages, resulting in duplicate deployments.
|
DEV-466815* |
|
The layout shown in a checklist design preview does not match the layout as it appears to users.
|
DEV-481245* |
|
In some instances, file names with special characters may be corrupted when uploaded to a Vault's file staging server.
|
DEV-550256 |
|
Users may experience a network issue when attempting to save email bodies.
|
DEV-550394 |
|
Labels on the Standard Metrics State Mappings page are incorrect.
|
DEV-552144* |
|
In some cases, users may observe that the Notifications panel loads slowly.
|
DEV-552560 |
|
In rare cases, Vault Compare reports may show differences in language translations of workflow steps.
|
DEV-552777 |
|
When a user navigates to the Admin tab collection from a document or object record page without saving changes, Vault displays a blank page.
|
DEV-553443* |
|
In some cases, when selecting links in Annotation Reply notifications, users may encounter a Network Issue error banner.
|
DEV-554215* |
|
Firefox users briefly see a red error banner when navigating from an Admin page to a non-Admin page.
|
DEV-554739* |
|
When configuring tab collections, if a user removes an inactive tab from the Selected column and then enters its name in the Search Available bar, Vault displays a blank screen.
|
DEV-554842* |
|
In some cases, Vault shows jobs in the system audit trails that are not visible in the UI.
|
DEV-556508 |
| Description |
Issue No. |
|
In som cases, Vault may display an error when attempting to save a Generate Document from Document Template action configuration which includes certain Application Roles.
|
DEV-537061* |
|
When using the Surveillance application, on generated eMDR forms, the Age value may not display as expected if no Date of Birth field value was entered.
|
DEV-538199* |
|
In Vault LIMS, in cases where test results have been modified, duplicate specification evaluation records may incorrectly appear on the Certificate of Analysis.
|
DEV-548845* |
|
In the Risk Builder, behavior when pressing the Enter key may be inconsistent.
|
DEV-551827* |
|
Users experience a network error message when expanding the associated change request section in a document change control record on a Quality Vault.
|
DEV-555235 |
|
Evaluated results may display with incorrect notation.
|
DEV-556240* |
|
E-learning or external training assignments may not open as expected from mobile web or mobile application interfaces.
|
DEV-556457* |
|
The "Enable Validation Inventory Application Security" Admin option may incorrectly appear in Validation Management Vaults.
|
DEV-557395* |
| Description |
Issue No. |
|
In some cases, Vault displays a server error when the Add User to Role entry action is triggered in the Controlled Copy Trace lifecycle.
|
DEV-545624* |
|
In some cases, Admins can create related child record components past the configured maximum limit through MDL.
|
DEV-547297* |
|
In some cases, Vault does not autosave a 5 Why node after cancelling a node deletion.
|
DEV-550597* |
|
In some cases, Vault displays an unexpected User Exception Message detail when changing a QualityOne training material document to an Obsolete state.
|
DEV-552406* |
|
In some cases, the Type and Product filters on the Documents section of the Visual Hierarchy Process Details page do not work properly.
|
DEV-556212* |
|
In some cases, Vault lags in retrieving the viewable rendition of a CrossLink document if the version is changed while the rendition is being generated.
|
DEV-556969* |
|
In some cases, users cannot select picklist options containing special characters when configuring the Populate HACCP Plan user or entry action.
|
DEV-557994* |
| Description |
Issue No. |
|
When a user runs on-demand publishing on a single document within an STF, Vault up-versions all documents within the STF.
|
DEV-326667* |
|
Vault incorrectly reports CN rule 6.26 as passed in Content Plan sections 2.7.4, 3.2, 4.2, and 5.3 when a matched PDF document contains unembedded non-standard fonts.
|
DEV-477350* |
|
When a grouped Submission is created in PromoMats and the xml_ich_dtd_xsd_version__v field rule is inactive in RIM, the connection does not populate the XML Sequence ID field in the related submission records.
|
DEV-530176* |
|
In some cases, when permalinks target a document matched to a Content Plan Item that is locked to a previous version, the permalinks are removed during continuous publishing.
|
DEV-536633* |
|
Submission Wizard users are able to create Submission Active Substance and Regulatory Objective Active Substance records, even if a user does not have read access to fields on the Application source record.
|
DEV-540440* |
|
When Vault sends a compliance package from PromoMats to RIM, the RIM CrossLinks Post Processing job fails if the package contains approximately 10 or more CrossLink documents.
|
DEV-541697* |
|
When managing registered details, users cannot update Formatted Number field values.
|
DEV-547778* |
|
Users receive a “Page Not Found” error when attempting to access a Submissions Archive export from the notification.
|
DEV-548163* |
|
In some cases, the RMS Integration and Synchronization job creates duplicate Controlled Vocabulary records with the same SPOR IDs.
|
DEV-550815 |
|
When the Published Output Location of an STF XML Content Plan Item is updated, Vault does not up-version the STF XML during continuous publishing.
|
DEV-551332* |
|
When a document targeted in a Vault link annotation changes state, Vault displays a document placeholder instead of the published document version.
|
DEV-551382* |
|
When validating AU 4.3.2 and 4.3.3, Vault returns ambiguous error details when elements are missing.
|
DEV-552047* |
|
Vault may fail to send a notification after completing the Dispatch Global Content Plan action.
|
DEV-552898* |
|
When a published STF document is unmatched, Vault displays the document in the incorrect location in the legacy Submissions Archive Viewer after continuous publishing.
|
DEV-552925* |
|
If a Correspondence document is tagged for the application only, it does not display in the new Submissions Archive Viewer when the current view includes the Submission column.
|
DEV-554183* |
|
In some cases, the Delete Inactive Content Plans SDK job may fail.
|
DEV-554413 |
|
When users apply a Submission filter, the new Submissions Archive Viewer displays the Save View (instead of Save View As) button.
|
DEV-554554* |
|
When Vault imports a submission, the import notification includes a false warning message if the submission’s index-md5.txt file contains a checksum value with a trailing new line character.
|
DEV-554719 |
|
The new Submissions Archive Viewer does not sort Correspondence documents when users Sort A-Z.
|
DEV-554730* |
|
When displaying inactive Submissions and Applications in the new Submissions Archive Viewer, the Lifecycle State filter includes all lifecycle states (instead of just those applicable to the inactive records).
|
DEV-555197* |
|
When users click a document’s “Where used in archive” link, Vault opens the new Submissions Archive Viewer to the default view instead of the document’s section.
|
DEV-555445* |
|
Users who have unchecked the requiredness on Administered Products and then attempt to load them into a Vault may experience errors that prevent the SDK from triggering and the expected joins from being created.
|
DEV-555466 |
|
Users are unable to Favorite documents within the new Submissions Archive Viewer.
|
DEV-555644* |
|
The new Submissions Archive Viewer displays rows referencing deleted Submissions Archive documents.
|
DEV-555934* |
|
The new Submissions Archive Viewer displays the latest version for all submissions containing the same document.
|
DEV-555937* |
|
Vault incorrectly fails CA rule F05 when an M1 reference leaf Content Plan Item’s xlink_href__v field is a relative path.
|
DEV-556051 |
|
The new Submissions Archive Viewer displays duplicate eCTD sections for US region v3.3 and 2.01.
|
DEV-556523* |
|
When applying a Product Family filter in the Active Dossier Viewer and Editor, Vault allows users to select inactive records.
|
DEV-557603* |
|
When using the Export Tree with All Descendants action in the Content Plan, Active Dossier, and Submissions Archive viewers, users without Business Admin access cannot view links from the resulting Excel file.
|
DEV-558157 |
|
For Japanese submissions, the new Submissions Archive Viewer incorrectly displays the operation name.
|
DEV-558594* |
The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on March 21, 2023.
| Description |
Issue No. |
|
Executing reports in different languages produces inconsistent results.
|
DEV-513646 |
|
When a multi-pass report with types Document and EDL Item with Matched Document enables the "Include full text for long text fields" option, and an EDL Item has a rich text field, running the report results in an unexpected error.
|
DEV-527249 |
|
Users may experience a 'Server having problems' error when attempting to expand filters in the UI for ad-hoc reports that were run in the background.
|
DEV-528397 |
|
When a user does not have permission to view a hidden long text object field, running a report on the object with the "Include full text for long text fields" option results in a "Server having problems" error.
|
DEV-541445 |
|
Attempting to remove duplicate documents from a report filter and then viewing the report causes Vault to display a "Server having problems" error.
|
DEV-546206 |
|
Under certain circumstances, executing a Multi-Pass report with advanced filter logic results in a server error.
|
DEV-548668* |
|
In some cases, matched document reports with advanced filter logic display the wrong number of documents or placeholders.
|
DEV-549076 |
|
Multi-Pass reports with the Document with Document Role view that filter on Document Role > Role Name include incorrect information.
|
DEV-551056* |
|
Some users may experience validation errors when skipping report filters with advanced logic.
|
DEV-559876* |
The Safety release, including all Platform fixed issues, is targeted for tentative availability on March 16, 2023.
| Description |
Issue No. |
|
Fixed an issue where, when searching by Preferred Name in the WhoDRUG Browser, generic drugs were not returned in the search results. Now, you can filter on generic drugs by entering "generic:y" in the Search bar.
|
SAF-31080 |
|
Fixed an issue where, when promoting an Inbox Item, the audit trail did not log Potential Matches search results if the Create New Case, Mark as Duplicate, Mark as Follow-Up, or Create Follow-Up actions were used.
|
SAF-34932 & SAF-36564 |
|
Fixed an issue where, if a triage workflow was configured to populate a specified field with a value if that field was blank on intake, when an Inbox Item was created from an E2B file the lifecycle state was updated before the workflow was complete.
|
SAF-36974 |
|
Fixed an issue with promoting Cases from the Case Compare page where, when an error occurred due to missing Read permission for the Language field, the system error message did not describe the cause of the issue.
|
SAF-37207 |
|
Fixed an issue with 22R3 deep duplicate detection where Study Number was included in the ID match criteria, resulting in too many Likely Match suggestions. Now, Study Name and Study Number are included in the Matching Reporter criteria.
|
SAF-37574 |
|
Fixed an issue with Case promotion where, when the Potential Matches page included both likely and possible matches, the possible match results were not ranked in the correct order.
|
SAF-37847 |
|
Fixed an issue where, when auto-calculation was turned off, Age fields were auto-calculated after Case promotion for Inbox Items created through E2B-import.
|
SAF-37874 |
Previously, when merging to an In-Flight Case or creating a Follow-Up Case, if either the Inbox Item or matched Case included at least one Case child object that exceeded the system limit of 500 records, the action was prevented by the system. Now, Vault Safety supports up to 1,500 Case child objects on a maximum of three (3) objects.
Enablement: Support
|
SAF-37884 |
|
Fixed an issue where, when a User Profile was set to any value other than English, the Dosage Frequency Unit field did not display selected values.
|
SAF-38025 |
|
Fixed an issue with automated Case promotion where, when 22R3 deep duplicate detection was enabled and set to consider Inbox Items, promotion failed when the most likely ID match was an Inbox Item.
|
SAF-38058 |
|
Fixed an issue where Products with a Drug Role of "Similar Device" were being included on non-FDA Transmission documents.
|
SAF-38225 |
|
Fixed an issue where, when the Device Code entered in the Case Product Device Code field was not a level 3 code, the corresponding FDA code was not exported to FDA E2B(R2), FDA VAERS E2B(R3), and FDA 3500A files.
|
SAF-38235 |
|
Fixed an issue where, when the Potential Matches screen returned more than 20 results, reviewing the left pane list of all potentially matching Cases was difficult. The pane now includes a scrollbar for better usability.
|
SAF-38284 |
|
Fixed an issue with FDA E2B(R2) export where, when a Combination Product included Drug and Company Product constituents and the Company Product had a Drug Role of "Similar Device", the Company Product was not included in a B.4 Drug(s) Information block of the file.
|
SAF-38297 |
|
Fixed an issue where CIOMS I and FDA 3500A forms failed to generate when Case Result (Text) fields included non-numeric values.
|
SAF-38302 |
|
Fixed an issue where, when a Case included a Company Product with a Product Type of Device and the associated Malfunction field was set to Yes, the Case-level Device Report Type field was not populated with "Malfunction".
|
SAF-38312 |
|
Fixed an issue where, when a Study was set up with Unspecified Products, Watchlist tags were not applied to associated Study Cases. Now, when a Study has Unspecified Products, Watchlist tags are applied to Case Products.
|
SAF-38355 |
|
Fixed an issue where, when sending Submissions and Distributions over email, the full email body was captured in the Initial Message Sent event type of the Email Events Log. This created the potential for personally identifiable information (PII) to appear in the log.
|
SAF-38460 |
|
Fixed an issue with Case promotion where, in some instances, the Potential Matches page did not appear and a system error was displayed but the Inbox Item was promoted.
|
SAF-38785 |
| Description |
Issue No. |
|
When an HVO Object is used for a related object section and a VQL filter is applied to that section, selecting Show in Tab for that section will show all related records rather than the filter.
|
DEV-441776* |
|
In some cases, the Where Used page is not exported properly for exported documents.
|
DEV-545755 |
|
In some cases, users searching for text values may see unexpected characters in text fields in the results.
|
DEV-547371 |
|
Users may be unable to perform a bulk action on an object after searching for a matching record ID. Additionally, they may notice special characters when viewing the audit trail for a matching document number.
|
DEV-548525 |
|
In some cases, when a user uploads an unclassified document with study metadata extraction and document classification configured, the document is autoclassified, but the Study field is not autopopulated.
|
DEV-550302* |
|
In cases where users search for specific record IDs, they may be unable to inline edit objects with atomic field security.
|
DEV-551521 |
|
When navigating to a tab with a default view to which they do not have access, users may receive a 'Server having problems' error.
|
DEV-551870 |
|
In some cases, users are unable to filter tasks by Document Type.
|
DEV-552029* |
|
In some cases, when a user refreshes the page after removing a filter from a document search, the latest version icon may disappear.
|
DEV-552454* |
|
In some cases, after freezing a column in a search grid, the drag line and cursor do not disappear.
|
DEV-553399* |
|
In some cases, when a user with no group-roles attempts to view the responsible roles for a prior document that was shared with them, they may receive a server error.
|
DEV-554081* |
|
In some cases, Advanced Search does not work as expected when Include attachments is selected.
|
DEV-555075 |
|
When attempting to perform an inline edit after searching for a matching record ID, users may receive a server error.
|
DEV-555425 |
|
In some cases, hidden fields show up in Excel reports.
|
DEV-556043* |
|
Users are unable to complete other actions on the same page after performing an inline edit.
|
DEV-556589* |