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 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.
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 20R1 Maintenance Releases.
Note The following maintenance releases were deployed to General Release vaults.
July 2020
July 30, 2020
Release Number: 20.1.0.12 | Build Number: 734
| Category | Issue Description | Issue No. |
|---|---|---|
| Case Processing: Data Entry | Fixed an issue where the “Determine Due Date” action was calculating the Case Due Date incorrectly. | SAF-8501 |
July 23, 2020
Release Number: 20.1.0.11 | Build Number: 725
| Category | Issue Description | Issue No. |
|---|---|---|
| Coding: MedDRA | Fixed an issue where the MedDRA dictionary did not consolidate with the existing terms in the system when an older version of the MedDRA dictionary was loaded. | SAF-7424 |
July 15, 2020
Release Number: 20.1.0.10 | Build Number: 709
| Category | Issue Description | Issue No. |
|---|---|---|
| Aggregate reports: Table Generation | Fixed an issue where Cases in the superseded state were excluded in the generated cumulative serious adverse events for DSUR reports. | SAF-7887 |
June 2020
June 30, 2020
Release Number: 20.1.0.9 | Build Number: 666
| Category | Issue Description | Issue No. |
|---|---|---|
| Case Processing: Data Entry | Fixed an issue where users were unable to save a Case Product when they entered a custom Dosage unit. | SAF-7550 |
| Safety Data Exchange: E2B Export | Fixed an issue where, when generating an ICH or EMA E2B (R3) file, the Start and End date fields in the Case Adverse Event record were exported as invalid E2B values in section E when these fields had nullflavors. Also, when the Case Adverse Event record contained only the End date and Duration values, the corresponding Section E data elements were exported in an incorrect order. | SAF-7502 |
| Safety Data Exchange: E2B Export | Fixed an issue where, when generating an ICH or EMA E2B (R3) file for a Case with a blank Gender field, the Gender field was exported as a blank nullflavor instead of being omitted from the generated file. | SAF-7500 |
| Safety Data Exchange: E2B Export | Fixed an issue for E2B (R3) XML expression rules for Section F where, to support the values or combination of E2B (R3) data elements, XML needed to be structured based on the populated values. | SAF-7433 |
| Safety Data Exchange: E2B Export | Fixed an issue for E2B (R3) XML expression rules for Section E where, to support the values or combination of E2B (R3) data elements, XML needed to be structured based on the populated values. | SAF-7431 |
| Safety Data Exchange: E2B Export | Fixed an issue for E2B (R3) XML expression rules for Section G where, to support the values or combination of E2B (R3) data elements, XML needed to be structured based on the populated values. | SAF-7323 |
| Safety Data Exchange: E2B Export | Fixed an issue where, when a Case contained more than one Case Assessment with the same outboundRelationship fields populated (i.e. Start and End Date, Recurrence), the outboundRelationship fields were exported in an incorrect order in the generated E2B (R3) file. | SAF-7322 |
| Safety Data Exchange: E2B Export | Fixed an issue where an error appeared when uploading an EMA E2B (R3) XML file to EVWEB and submitting the same file through EMA Gateway. | SAF-7279 |
June 17, 2020
Release Number: 20.1.0.8 | Build Number: 657
| Category | Issue Description | Issue No. |
|---|---|---|
| Submissions: Follow-Ups | Fixed an issue where a Submission record was not automatically generated for Follow-Up Cases when the initial imported Case did not have a Submission. | SAF-6672 |
| Submissions: Follow-Ups | Fixed an issue where the system was automatically generating Submission records for non-SUSAR and non-SAE Follow-Up Cases. | SAF-5988 |
| Submissions: Follow-Ups | Fixed an issue for Follow-Up Study Cases where, to automatically create the follow-up Submission, the system required the initial Case to have a completed Submission. Now, for Follow-Up Study Cases, the system generates a Submission when the current or previous Case version is a SUSAR, regardless of the initial Case Submissions. | SAF-6834 |
| Case Processing: Data Entry | Fixed an issue where a Read-only Value field was left blank in Case Product when its Unit field was blank. Now, the system will issue an “Invalid” icon when a Unit field is left blank. | SAF-6804 |
| Case Processing: Follow-Ups | Fixed an issue where an error message appeared without stating the actual cause of the error after creating a Follow-Up Case with two open Case versions. | SAF-6669 |
| Submissions: Follow-Ups | Fixed an issue for Submission and Distribution records in Follow-Up Study Cases where a Transmission record was created for all possible scenarios (i.e. Product and Study, Registration/Country/Agency) because there were no rules to identify when a Transmission record should be created. Now, for Follow-Up Study Cases, a Transmission record is created only when a Registration exists for the Study associated with the Case. | SAF-7453 |
| Submissions: Follow-Ups | Fixed an issue where reporting rules were generating additional Submissions and Distributions on Follow-Up Study Cases when the Study was not associated with those reporting rules. | SAF-7445 |
| Case Processing: Data Entry | Fixed an issue where, when multiple dosages with invalid Unit values were inputted in a Case Product, an “Invalid” icon appears for the last dosage only. | SAF-7417 |
| Case Processing: Data Entry | Fixed an issue where, when a dosage with invalid values was deleted from the Case Product, the user was unable to save the Case Product. | SAF-7415 |
| Case Processing: Data Entry | Fixed an issue where, when a Dose value was inputted without a unit, an error message did not appear and the user was allowed to save the Case Product successfully. | SAF-4712 |
June 8, 2020
Release Number: 20.1.0.7 | Build Number: 602
| Category | Issue Description | Issue No. |
|---|---|---|
| Intake: E2B Import | Fixed an issue where, when using B.4.k.5.3 in an E2B (R2) file, product dosages were aggregated on import. | SAF-6655 |
| Security: Object Administration | Fixed an issue where a server error appeared when a user without permissions to read User security tried to create records on Safety objects with an api_name field. | SAF-6828 |
| Submissions: EMA Gateway | Fixed an issue where EVWEB XSD validation failed after selecting “Cyclical”, “As Necessary”, or “Total” for Frequency instead of a value. | SAF-6806 |
May 2020
May 22, 2020
Release Number: 20.1.0.6 | Build Number: 570
| Category | Issue Description | Issue No. |
|---|---|---|
| Aggregate Reports: Table Generation | Fixed an issue where the interval column did not include the latest New Info Date in range for PBRER Number of Product Reactions by Term for Postmarketing Sources table. | SAF-6648 |
| Aggregate Reports: Table Generation | Fixed an issue where cumulative case calculations were not considering the correct start date when generating aggregate reports. | SAF-6605 |
May 20, 2020
Release Number: 20.1.0.5 | Build Number: 550
| Category | Issue Description | Issue No. |
|---|---|---|
| Case Processing: Notifications | Fixed an issue where a descriptive error message did not appear when Follow-Up Case creation failed due to a Case field referencing an inactive Controlled Vocabulary record. | SAF-6449 |
| Case Processing: Relatedness | Fixed an issue where Case Relatedness was not properly set to Not Related when Case Assessment Result(s) referenced custom Controlled Vocabulary records for the company source using E2B values 2 or 4. | SAF-6447 |
| Case Processing: Audit Log | Fixed an issue where the audit log recorded that the system created Follow-Up Cases instead of the user who triggered the action. | SAF-6344 |
May 14, 2020
Release Number: 20.1.0.4 | Build Number: 525
| Category | Issue Description | Issue No. |
|---|---|---|
| Case Processing: Follow-Ups | Fixed an issue where Follow-Up Cases created from a non-expedited closed Case were being expedited. | SAF-6341 |
| Case Processing: Expectedness | Fixed an issue where after you manually changed the auto-calculated Expected field to set the value to Yes (Overriden), the system updated the Expedited field to No instead of leaving the Expedited field as-is. | SAF-6123 |
| Case Processing: Follow-Ups | Fixed an issue where the Expected (expectedness) fields on Follow-Up Cases did not match the field values from the initial Case. | SAF-6096 |
| Case Processing: Notifications | Fixed an issue where users were unable to open links to documents or Cases from vault notifications. | SAF-5874 |
May 6, 2020
Release Number: 20.1.0.3 | Build Number: 497
| Category | Issue Description | Issue No. |
|---|---|---|
| Case Processing: Follow-Ups | Fixed an issue where you could not create a Follow-Up Case from a Case containing multiple Case Product or Case Adverse Event records with identical names. | SAF-6157 |
April 2020
April 30, 2020
Release Number: 20.1.0.2 | Build Number: 454
| Category | Issue Description | Issue No. |
|---|---|---|
| Form Generation: FDA 3500A | Fixed an issue where the value from the Event (Reported) - English field was not populated in section B.5 of the FDA 3500A form. | SAF-5872 |
| Form Generation: CIOMS I | Fixed an issue where the value from the Event (Reported) - English field was not populated in section 7+13 of the CIOMS I form. | SAF-5871 |
| Case Processing: Triage | Fixed an issue where, when a preconfigured Study Site had a blank Registration field, a NullPointerException error appeared when a user tried to complete the Triage task. | SAF-5620 |
