A maintenance release contains fixes for issues affecting customer Vaults in production environments. Maintenance releases can occasionally include enhancements, for example, a time-sensitive regulatory requirement. This page covers maintenance releases deployed to General Release Vaults only. We communicate 24 hours prior to a maintenance release. There may be a short service disruption during deployment. The Veeva Trust Site provides the most up-to-date information on Vault’s service status. Check this site to view the current status of Vault PODs and upcoming scheduled system maintenance.
This list only covers fixes for issues that impact 23R1 General Release versions of Safety Vaults. The list of fixed issues is subject to change until the release occurs. When we identify issues to fix in a maintenance release, we attempt to get them into the earliest release possible. Sometimes, we target a specific release but are not able to deliver a fix early enough for full testing. In situations like this, we postpone the fix for a later release and strike out the description in this list.
We number maintenance releases for Safety by appending the number of the Safety-specific maintenance release to the General Release number. The most recent Vault General Release is 23R1.0, so our maintenance releases for this version are 23R1.0.2, 23R1.0.3, and so on.
Vault frequently delivers Platform maintenance releases. Safety deploys these Platform maintenance releases at a later date, along with any required fixes to Safety. For details on Platform fixes in these maintenance releases, see 23R1 Maintenance Releases.
Last Updated: September 5, 2023
August 1, 2023 Postponed to August 8, 2023
Release Number: 23.1.0.14 | Build Number: 360
This release affects only internal logging and contains no customer-facing fixes.
July 25, 2023
Release Number: 23.1.0.13 | Build Number: 359
| Description |
Issue No. |
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Fixed an issue where, when Strict Case Locking was enabled, a system error occurred when non-Vault Owners tried to promote a Pregnancy Inbox Item.
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SAF-43955 |
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Fixed an issue where, during cross reporting for Marketing to Marketing scenarios, reporting obligations for Cases with multiple products with different cross-reporting eligibility were not evaluated correctly.
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SAF-44943 |
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Fixed an issue where, when evaluating Distributions for a destination, only the first-created Partner Distribution List was evaluated.
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SAF-43182 |
July 18, 2023
Release Number: 23.1.0.12 | Build Number: 344
| Description |
Issue No. |
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Fixed an issue with Gateway E2B import where Case details were stored in the Body field of the Inbound Transmission record. This created the potential for personally identifiable information (PII) to appear in the log.
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SAF-44032 |
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Fixed an issue with evaluating the Transmission Reason reporting rule parameter for Imported Cases where, when the previous imported Case version did not have Transmissions to same reporting destination, Transmission Reason was set to Follow-up.
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SAF-43146 |
July 11, 2023
Release Number: 23.1.0.11 | Build Number: 341
| Description |
Issue No. |
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Fixed an issue with Vaults cloned from the 23R1 template where EDQM mappings were not created.
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SAF-42937 |
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Fixed an issue with attaching documents to Transmissions where, if an attachment had no text in the Description field but had text in the Description(continue) field, the word "null" appeared before the text in the Documents Held by Sender data element — C.1.6.1.r.1 on E2B(R3) reports and A.1.8.2 on E2B(R2) reports.
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SAF-43760 |
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Fixed an issue with Marketing to Marketing and Marketing to Investigational cross reporting scenarios where, when Substances were not an exact match, cross-agency reports were not generated as expected.
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SAF-43183 |
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Fixed an issue where, when a Case contained no eligible Products for a specific agency, custom SDK Reporting Rule Parameters for that agency’s Rule Set resulted in an error.
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SAF-41144 |
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Fixed an issue where, in some instances, document preview regeneration failed.
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SAF-41225 |
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Fixed an issue on Inbox Items where, if Case Access Group Security was enabled, custom-type Action Item records could not be displayed.
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SAF-42567 |
June 27, 2023
Release Number: 23.1.0.10 | Build Number: 329
| Description |
Issue No. |
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Fixed an issue where email questionnaires were not generated for Blinded Study Cases although questionnaire templates without specified Products existed.
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SAF-41139 |
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Fixed an issue where the Translation Connection Languages and Translation Settings records were not included in the Vault Safety template.
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SAF-41671 |
June 20, 2023
Release Number: 23.1.0.9 | Build Number: 318
| Description |
Issue No. |
Vault Safety has the option to ignore the Transmission Lifecycle State when considering if a Case qualifies as an Upgrade or Downgrade report to a specific destination. Previously, the Upgrade and Downgrade parameters did not consider if the previous Case version was submitted.
Enablement: Support
Default Impact: None
GxP Risk: High
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SAF-32767 |
June 13, 2023
Release Number: 23.1.0.8 | Build Number: 311
| Description |
Issue No. |
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Fixed an issue where promoting Pregnancy Inbox Items to Cases was prevented when Organization was set to required on the Child Information object type.
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SAF-42299 |
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Fixed an issue with Pregnancy Cases where, when the Linked Cases section included a Non-Child information Case, Follow-up Case creation was prevented.
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SAF-42579 |
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Fixed an issue with PBRER generation where, if a Case had multiple versions with different Report Types within a reporting interval, the Case was overcounted on the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources.
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SAF-40009 |
June 6, 2023
Release Number: 23.1.0.7 | Build Number: 305
| Description |
Issue No. |
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Fixed an issue with E2B(R3) import of a single Case where, when the Study in the source file did not match a Study in the Business Admin library, the system incorrectly populated the ACK.A.4 Transmission Acknowledgement Code with "AE—E2B Import with Warnings", instead of "AA—E2B Import Success".
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SAF-40258 |
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MedDRA Fixed an issue where, when the MedDRA Dictionary Language was set to two languages and the Update to Latest Version action was run, an error appeared. This was due to duplicate Localized MedDRA records being created..
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SAF-42520 |
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Fixed an issue where, when voiding a Case and submitting one last time, the Previously Submitted Reporting Rule Parameter specified that Transmissions in only the "E2B ACK Accepted" or "Completed" states were evaluated. Now, a new option, All Transmission States, supports evaluating Transmissions in any lifecycle state, unless the Transmission is inactive or deleted.
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SAF-41082 |
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Currently, sharing rules and user roles are used to send notifications and emails. If using Case Access Group Security instead, sharing rules must be deleted for the object. Fixed an issue where, when Case Access Group Security was enabled, notifications were not received by the respective users. Now, if Case Access Group Security is enabled, user IDs can be obtained through User Access Group Assignments.
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SAF-42788 |
May 31, 2023
Release Number: 23.1.0.6 | Build Number: 294
| Description |
Issue No. |
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Fixed an issue with deep duplicate detection where, on the Potential Matches page, some cases with matching Gender and Country fields were ranked higher than expected, while some with matching Patient Initials were ranked lower than expected.
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SAF-40847 |
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Fixed an issue with E2B import where, when the two-letter ISO country code in the source file matched multiple Country records, the system mapped the country code inconsistently. Now, the system matches the country code to the first Country record in alphabetical order based on country name.
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SAF-39400 |
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Fixed an issue where, when Inbox Items were created from ZIP or E2B files with multiple cases, values entered in the Origin field of the Case Information section was not imported.
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SAF-40033 |
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Fixed an issue where, when some E2B XML files encoded as UTF-16 were received through an AS2 gateway, the Transmissions were not imported as Inbox Item.
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SAF-42519 |
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Fixed an issue with Cases that included one constituent Product of a Combination Product where, when the Combination Product field was set, Combination Product constituents of the Company Product type were added with the Base Product type.
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SAF-40303 |
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Fixed an issue with promoting manually created Inbox Items to Follow-Up Study Cases where, when the Study Product was open-label, an additional blinded instance of the same Study Product appeared on the Follow-Up Case and had to be manually deleted.
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SAF-41860 |
Fixed an issue with E2B export where nullFlavors for Case Product Dosage Batch/Lot Number Reason Omitted field values were incorrectly populated in the G.k.4.r.7 - Batch / Lot Number data element.Now, Reason Omitted field nullFlavors are exported as follows:- EMA E2B(R3): Blank or Unknown = UNK, Masked = MSK, Asked But Unknown = ASKU
- ICH E2B(R3), FDA VAERS E2B(R3), and PMDA E2B(R3): Blank, Masked, Asked But Unknown = no nullFlavor exported
Validation Criteria updates are as follows:- FDA.G.k.4.r.7 Batch/Lot Number is no longer mandatory.
- PMDA.G.k.4.r.7 Batch/Lot Number is now mandatory only if PMDA Reporting Category (J2.1a) is 'AA' or 'DA'.
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SAF-38644 |
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Fixed an issue where, when voiding a Case and submitting one last time, the Previously Submitted Reporting Rule Parameter specified that Transmissions in only the "E2B ACK Accepted" or "Completed" states were evaluated. Now, a new option, All Transmission States, supports evaluating Transmissions in any lifecycle state, unless the Transmission is inactive or deleted.
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SAF-41082 |
May 18, 2023
Release Number: 23.1.0.5 | Build Number: 283
| Description |
Issue No. |
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Fixed an issue with promoting AERs to Cases where, if the AER included special characters, during duplicate detection the system displayed error messages and prevented promotion.
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SAF-41888 |
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Fixed a caching issue that, in some instances, prevented users with the Case Processing security profile from viewing the Drug page on Study Cases.
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SAF-42003 |
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Fixed an issue where, in some cases, users may have experienced performance issues when processing Cases.
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SAF-42023 |
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Fixed an issue with limits on the number of users allowed in a single role within a Case Access Group. This fix affects only POD VV1-1150.
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SAF-42068 |
May 16, 2023
Release Number: 23.1.0.4 | Build Number: 275
| Description |
Issue No. |
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Fixed an issue with Case promotion where the Potential Matches page did not include Cases with different Report Types. Now, the Potential Matches page matches across Report Types with the exception of Clinical Trial Study Cases, which will match only to other Clinical Trial Study Cases.
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SAF-40328 |
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Fixed an issue with E2B import where, if Inbox Items were opened while in the Importing state, some fields were not imported.
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SAF-39092 |
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Fixed an issue with the system-provided FDA ICSR Reporting Rule Set where the Rule Parameter for the Reporting Scenario "General Reporting, Investigational to Marketing (same agency)" was not included in the One Last Time rules.
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SAF-41008 |
May 9, 2023
Release Number: 23.1.0.3 | Build Number: 270
| Description |
Issue No. |
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Fixed an issue with E2B import where, when Cases included some parent information but did not include Parent Medical History or Parent Drug History information, parent Cases were not created.
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SAF-40063 |
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Fixed an issue with importing E2B files with blank Localization where, when the Enable Localization-based Mapping on Import feature was turned on, Parent Medical History Text was mapped incorrectly on the Inbox Item and then did not appear on Cases after promotion.
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SAF-41209 |
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Fixed an issue with cross reporting for Follow-Up Cases created from Imported Study Cases where, when the Eligible Products Based on Cross Reporting feature was turned on, all expected Submissions were not generated.
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SAF-41145 |
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Fixed an issue with Case Access Group Security where, in some instances, roles with access to personally identifiable information (PII) received system errors when processing Cases.
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SAF-41423. |
April 30, 2023
Release Number: 23.1.0.2 | Build Number: 256
| Description |
Issue No. |
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Fixed an issue where, in some instances, Case Adverse Events were not displayed and a system error occurred when the event included a MedDRA term that had undergone a hierarchy change and was in a Closed state.
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SAF-41825 |