Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
A maintenance release contains fixes for issues affecting customer Vaults. Maintenance releases can occasionally include enhancements, for example, a time-sensitive regulatory requirement.
We communicate 24 hours prior to a maintenance release when there will be a short service disruption during deployment.
The contents is subject to change until the release occurs. When we identify items for 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 an update early enough for full testing. In situations like this, we postpone the update for a later release and strike out the description in this list.
Veeva frequently delivers maintenance releases for the Vault Platform. Vault Safety deploys these Vault Platform maintenance releases at a later date. For details on the Vault Platform fixes in these maintenance releases, see Vault 23R2 Maintenance Releases.
Note This page covers maintenance releases deployed to General Release Vaults only.
November 2023
November 21, 2023
Release Number: 23.2.0.15 | Build Number: 345
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Coding: MedDRA |
When Inbox Item Medical Events or Product Indications include trailing white spaces, after Case promotion the system creates duplicate MedDRA records. | SAF-49850 |
November 14, 2023
Release Number: 23.2.0.14 | Build Number: 344
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Report Generation: E2B Export |
When generating FDA E2B(R2) Combination Product reports for Cases where the Device Report Type field includes Public Health Risk, the A.1.9 data element is not populated with code 4 unless the Case Product is a Device. | SAF-49959 |
November 7, 2023
Release Number: 23.2.0.13 | Build Number: 340
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: Case Promotion |
When an Inbox Item includes a Study Product with a Drug Role of Concomitant, after Case promotion the Study Product is Blinded. | SAF-47965 |
| Intake: E2B Import |
When creating AERs from E2B-import through Vault AS2 Gateway, ACK2 messages are not sent. | SAF-49159 |
| Intake: Duplicate Detection |
After importing a high volume of Cases, if indexing of migrated cases for duplicate search is initiated, in some instances the process fails. | SAF-48974 |
October 2023
October 31, 2023
Release Number: 23.2.0.12 | Build Number: 334
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Report Generation: E2B Export |
When generating E2B(R2) files for Cases with multiple indications, B.4 Drug(s) Information blocks can now be generated for each indication. Previously, indications other than the first one on the Case were exported to the B.4.k.19 Additional Information on Drug (free text) data element. Enablement: Support |
SAF-46205 |
| Transmissions: Gateway Transmissions |
In some instances, non-AS2 Connections are activated by AS2 Connection-only triggers. | SAF-47798 |
| Transmissions: Transmission Generation |
During cross reporting, expected back reporting Transmissions are not generated when back reporting is configured on related agency Transmission Profiles. | SAF-49061 |
| System: Object Administration |
When generating Substance Aliases, the system does not reference the 250-character Substance Name and Localized Substance Name fields. | SAF-49268 |
October 24, 2023
Release Number: 23.2.0.11 | Build Number: 327
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: Case Promotion |
When creating a Follow-up Case or merging to an In-flight Case, the Case-level Reporter Country field is not updated. | SAF-43369 |
| Intake: E2B Import |
On Domestic Cases for Japan, when imported E2B files include Case Assessment Results data, Localized Narrative documents are not generated after Case promotion. | SAF-47944 |
| Intake: E2B Import |
On Inbox Items created from imported E2B(R2) files, the Patient RoA TermID Version is always set to 2.0 regardless of the version in the Route of Administration record. | SAF-49006 |
| Case Processing: Domestic Cases |
When the Localization record for Japanese (Japan) is set to generate Localized Assessments for Case Product Registrations, Domestic Case creation fails for inbox items with Localization set to "Japanese". | SAF-45649 |
| Transmissions: Transmission Generation |
When generating Transmissions for Company Product Case Products, the Transmission Product Type set up on the Product Registration is not used to match to the Product Types set up on the Transmission Profile Scope. | SAF-47443 |
| Transmissions: Transmission Generation |
One Last Time reports are generated for destinations that do not have back reporting configured on the Transmission Profile. | SAF-48204 |
| System: Performance |
In some instances, system performance is slower than expected when loading individual Inbox Items. | SAF-47239 |
| System: Vault Management |
Localized Reason Omitted records are not included in cloned Vaults. | SAF-47184 |
| System: Vault Management |
In Vaults cloned from a Vault with a link to the gateway service, the Sync the Connection to Gateway action is prevented for AS2 Gateways. | SAF-47634 |
| System: Vault Management |
Errors occur when refreshing a sandbox from a snapshot of a Vault with AS2 Connections. | SAF-47803 |
October 17, 2023
Release Number: 23.2.0.10 | Build Number: 317
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: Case Promotion |
During Case promotion, merging to an In-flight Case does not complete when there are more than 500 Case Assessment Expectedness records, and the Inbox Item remains unprocessed in the system. | SAF-46707 |
| Coding: WHODrug |
During External Product coding, if the Country Obtained field is populated with "United Kindom (Northern Ireland)" or "United Kingdom (Great Britain)", when the WHODrug Browser is opened the country filter is set incorrectly. | SAF-43648 |
| Report Generation: E2B Export |
When generating PMDA E2B(R3) files for a Study Case where there is no Localized Study child record for Japan, the C.5.2 data element is not included in the file. | SAF-47001 |
| Report Generation: FDA 3500A |
When generating FDA 3500A files for Cases with Devices or Combination Products with Devices, multiple checkboxes are not selected in the H.1 Type of Reportable Event field when they should be. | SAF-47066 |
| Transmissions: Validation Rules |
When generating Transmissions for imported Cases, validation failures related to MedDRA version and dates occur when the data is valid. | SAF-48339 |
October 12, 2023
Release Number: 23.2.0.9 | Build Number: N/A
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Coding: MedDRA |
Smart MedDRA Coding now supports MedDRA dictionary version 26.1. | SAF-47765 |
October 10, 2023
Release Number: 23.2.0.8 | Build Number: 312
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: E2B Import |
When importing an E2B file received through API transmission, if the Inbound Transmission specifies an Origin Organization where the PV Agreement field is set to Agent, the New Info Date field on the Inbox Item is set to the Transmission Generated date. | SAF-47959 |
| Case Processing: Data Entry |
Warnings don't appear when the Case Product Dosage Frequency field is missing either a unit or number value. | SAF-45081 |
| Transmissions: Gateway Transmissions |
AS2 Connections now supports submissions to the Russian Health Authority (RZN). Enablement: Support |
SAF-47922 |
October 3, 2023
Release Number: 23.2.0.7 | Build Number: 305
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: E2B Import |
When an E2B file does not include both values and units for First Dose Latency and Last Dose Latency, neither of the data elements are imported and the related Case Assessments are not generated. | SAF-44214 |
| Intake: E2B Import |
When importing E2B files through an AS2 gateway, ACK2 messages are not sent. | SAF-47099 |
| Case Processing: Follow-Ups |
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 |
| Case Processing: Medical Review |
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 |
| Case Processing: Narratives |
When Narrative document templates have merge tokens formatted in a table, after updating the Narrative on a blinded Case using that template, in some instances the Narrative preview and generated XML files do not reflect the changes. | SAF-47546 |
| Report Generation: E2B Export, FDA 3500A |
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 |
| Transmissions: Transmission Generation |
The system does not correctly identify whether Company-Product Combination Products have Device-type Product Constituents or other types of Product Constituents when generating FDA MedWatch 3500A, FDA E2B (R2) and E2B (R3), and EMA E2B (R3) files. | SAF-45308 |
September 2023
September 26, 2023
Release Number: 23.2.0.6 | Build Number: 297
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Case Processing: Localization |
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 |
| Report Generation: CIOMS I, E2B Export, FDA 3500A |
Headers from Narrative documents are appearing in generated ICSRs, resulting in non-compliant Transmissions. | SAF-48093 |
| Report Generation: E2B Export |
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 |
| System: Performance |
In some cases, users may experience performance issues when viewing Cases. | SAF-47205 |
September 19, 2023
Release Number: 23.2.0.5 | Build Number: 293
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: E2B Import |
Entering multiple values in the Device Follow-Up Type field is now supported. For more information, contact Veeva Support. | SAF-46546 |
| Case Processing: Narratives |
When a case narrative is updated, the narrative preview and generated XML file do not reflect these changes. | SAF-46100 |
| Transmissions: Reporting Rules |
Submissions are prevented when a single Reporting Rule is overridden by multiple Rules within another Rule Set. | SAF-46771 |
| Transmissions: Reporting Rules |
Safety Rule Configuration Reports do not correctly apply more than two levels of inheritance. | SAF-47048 |
| Transmissions: Reporting Rules |
Safety Rule Set Configuration Reports do not include Rule Set Parameters for inherited Rules. | SAF-47082 |
| Transmissions: Transmission Generation |
One Last Time (OLT) reporting is prevented if a previous Case version includes an inactive Transmission Profile or Organization. | SAF-47329 |
| System: Security |
When using Case Access Group security, Case role assignment does not consider the Localization set on the User Access Group Assignment record. | SAF-46088 |
September 12, 2023
Release Number: 23.2.0.4 | Build Number: 280
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: JSON Import |
Inbox items cannot be created from JSON files if the values entered in Controlled Vocabulary fields are invalid. | SAF-42899 |
| Intake: JSON Import |
After importing Cases received through version 23.2 of the Intake JSON API to Inbox Items, the Reasons Omitted fields are not populated. | SAF-47079 |
| Coding: WHODrug |
In some instances, WHODrug-coded Substance Names for External Products are missing parentheses, leading to incorrect population in the B.4.k.2.2 Substance / Specified Substance Name data element of E2B(R2) reports. | SAF-44531 |
| Report Generation: E2B Export |
When generating E2B files, Dose Forms from the Controlled Vocabulary are not truncated to 50 characters. | SAF-45515 |
| Transmissions: Reporting Rules |
The "Product" Reporting Rule Parameter does not evaluate whether Cases contain Company Products. | SAF-46175 |
| Transmissions: Reporting Rules |
When Combination Products made up of drug and device constituents are added to a Case, the device constituent is incorrectly included in the Most Conservative Product/Assessment (MCP/A) on the submission. | SAF-46711 |
September 7, 2023
Release Number: 23.2.0.3 | Build Number: 258
| Category | Issue Description | Issue No. |
|---|---|---|
| Vault Safety | ||
| Intake: Case Promotion |
When merging an Inbox Item to an In-Flight Case, after selecting new Assessment and Assessment Result values on the Case Compare page, the values are not updated on the new Case version. | SAF-45479 |
| Case Processing: Blind Protection |
For unblinded Cases, changing the Study Report Type to a custom value breaks the blind on Product Names. | SAF-42695 |
| Case Processing: Data Entry |
The system automatically voids Cases when there are no Primary Products or Assessments in their source E2B files, and the resulting error message does not reflect the real issue. | SAF-46260 |
| Report Generation: E2B Export |
When a PMDA Case has multiple LRDs, the values entered in some J2 fields and Localized Case Comments are mapped from the wrong LRD upon export. | SAF-44906 |
| Transmissions: Submissions/Distributions |
Reporting Rules are not evaluated correctly for Reporting Families with Product Registrations. | SAF-44332 |
