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 21R2 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 21R2.0, so our maintenance releases for this version are 21R2.0.1, 21R2.0.2, 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 21R2 Maintenance Releases.
Last Updated: August 12, 2022
December 1, 2021
Release Number: 21.2.0.14 | Build Number: TBD
| Description |
Issue No. |
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Fixed an issue where, when an AER from E2B import was promoted to a Follow-Up Case, the Study Registration was not downloaded from the Study library and was not added to the Case.
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SAF-23799 |
November 24, 2021
Release Number: 21.2.0.13 | Build Number: 553
| Description |
Issue No. |
|
This patch doesn't fix any issues but features logging improvements in Vault Management Console (VMC).
|
no issue number |
November 18, 2021
Release Number: 21.2.0.12 | Build Number: 550
| Description |
Issue No. |
|
Fixed an issue where E2B(R3) files with a Dose Text (G.k.4.r.8) value exceeding 1499 characters failed to import. The E2B(R3) standard character limit is 2000 characters.
|
SAF-23559 |
November 11, 2021*
| Description |
Issue No. |
|
Fixed an issue with the PADER Summary of ADR from Postmarketing Sources report where, if the Case Assessment Expectedness was overridden, the adverse event was detected as both labeled and unlabeled in the generated report.
|
SAF-22903 |
*This release was rescheduled to a later date.
October 28, 2021
Release Number: 21.2.0.11 | Build Number: 503
| Description |
Issue No. |
|
An enhancement in 21R1 resolved an unidentified long text truncation issue affecting Case Test Result Comments (F.r.6), Result (Text) Field (F.r.3.4), and Medical History Comments (D.7.1.r.5). This occurred when a case was copied for Follow-up or AER case promotion. This fix allows Veeva to identify previously impacted cases and then, with an approved change control (CC), restore the truncated data from the original. Impacted customers have already been contacted to proceed with full impact assessment and repair.
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SAF-21034 |
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Fixed an issue where the Product Registration information on an Open-Label or Single-Blinded Study was not carried over to the Case after promoting an Inbox Item.
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SAF-21367 |
October 14, 2021
Release Number: 21.2.0.10 | Build Number: 480
| Description |
Issue No. |
|
Fixed an issue where the Study field was not set on an imported Case from E2B if the Product did not match any Study Products in the system.
|
SAF-21777 |
October 7, 2021
Release Number: 21.2.0.9 | Build Number: 475
| Description |
Issue No. |
|
Fixed an issue with PADER Interval Line Listings where, if the Case Transmission Date was the same as the Data Period End, the Transmission Date was displayed as "-" in the date column on the aggregate report.
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SAF-21393 |
|
Fixed an issue where the Age field was not populated on the FDA 3500A form after report generation if only Age (normalized) was present. Now, if the Age value is blank on the Case, the Age (normalized) field (if present) will be exported and set as the Age on the FDA 3500A form.
|
SAF-22017 |
September 30, 2021
Release Number: 21.2.0.8 | Build Number: 456
| Description |
Issue No. |
|
Fixed an issue where Case Product Dosages could not be masked during report generation for blinded report previews and masked distributions, including CIOMS I, FDA 3500A, E2B R2, and E2B R3 report formats. You can now request, by support enablement, to mask dosage information for blinded report previews and masked distributions. Unless this behavior is requested and enabled, report generation continues to populate dosage information by default.
|
SAF-21618 |
September 23, 2021
Release Number: 21.2.0.7 | Build Number: 451
| Description |
Issue No. |
|
Fixed an issue by modifying the MFDS and NMPA Controlled Vocabulary Record API Names to match their corresponding picklist value names.
|
SAF-21195 |
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Fixed an issue where the normalized Height and Weight fields were not auto-calculated and were left blank upon promoting an Inbox Item to an Initial Case.
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SAF-21604 |
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Fixed an issue where an error appeared upon E2B(R3) import for the Test Result field (F.r.3.2) due to the value exceeding the maximum value limit. This resulted in the ICSR entering Error state.
|
SAF-21892 |
September 16, 2021
Release Number: 21.2.0.6 | Build Number: 426
| Description |
Issue No. |
|
Fixed an issue where the Receipt Date calendar displayed a different date than the value entered in the field.
|
SAF-20475 |
|
Fixed an issue where, when an AER was created from an E2B(R2) file, two additional Case Assessment Results were generated on the AER if the adverse event was populated with text but the MedDRA Code was missing.
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SAF-20530 |
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Fixed an issue where, when FDA CBER VAERS and FDA ESG were configured with the same Sponsor ID and Health Authority ID, an error appeared when trying to save the Gateway Profiles.
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SAF-20881 |
|
Fixed an issue with multi-Case E2B import where one of the Receipt Date fields was not populated upon import, which led to the Initial Receipt Date field being left blank on Follow-Up Cases.
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SAF-21436 |
September 12, 2021
Release Number: 21.2.0.5 | Build Number: 421
| Description |
Issue No. |
|
Reverted issue SAF-20355 (from 21R.2.0.4), because the fix to leave the Case Due Date field blank when the due date could not be calculated was causing the Evaluate Due Date action to clear the Case Due Date in certain circumstances. With this reversion, the Case Due Date field will no longer be left blank, and instead the previous behavior is restored to default to 30 days for non serious cases and 15 days for serious cases.
|
SAF-21762 |
September 9, 2021
Release Number: 21.2.0.4 | Build Number: 399
| Description |
Issue No. |
|
Fixed an issue where, if the Case Product does not have a registration, the Case Due Date field is set by default to 30 days for non serious cases and 15 days for serious cases. Now, if the Case Due Date field can't be calculated, it will be left blank by default.
(Reverted by SAF-21762 in 21R2.0.5)
|
SAF-20355 |
|
Fixed an issue where a server error appeared when a user tried to view a Case Test Result in Vault Management Console (VMC) > View Configuration.
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SAF-2103 |
|
Fixed an issue where, when two custom gateway profiles with the same Sponsor and Health Authority ID combination were saved, an error notification stated "Error updating profile" instead of stating the required details.
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SAF-21093 |
|
Fixed an issue where, when promoting an AER (from E2B import) with a null receiptdate_date__v field to a Follow-Up Case, a NullPointerException error appeared.
|
SAF-21444 |
September 2, 2021
Release Number: 21.2.0.3 | Build Number: 379
| Description |
Issue No. |
|
Fixed an issue where, when a migration user used the Promote to Case action, a blank Error pop up and a "Server having problems" message appeared.
|
SAF-18164 |
|
Fixed an issue with VAERS E2B(R3) where, in order to generate the Similar Device field in the E2B file, the primary product was required to be a vaccine. Now, if a Product with the Drug Role field set to Similar Device exists, the system populates E2B element G.k.1.a FDA Other Characterization of Drug Role.
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SAF-19460 |
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Fixed an issue where, when promoting an Inbox Item to Case, the Age at Onset and Age Group fields were not calculated and were left blank on the initial Case.
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SAF-20113 |
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Fixed a data compatibility issue with custom dose units entered on Inbox Items.
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SAF-20478 |
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Fixed an issue where duplicates of the MRN field in the Patient section were not detected by duplicate detection and were not displayed on the Potential Matches page upon promoting an Inbox Item.
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SAF-20781 |
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Fixed an issue where a server error appeared when an Inbox Item was imported from E2B or from the Intake API with the Localization field set to Japanese.
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SAF-20864 |
|
Fixed an issue with the DSUR and PBRER Cumulative Tabulation of Serious Adverse Events and the DSUR Cumulative Tabulation of Serious Adverse Reactions, where the aggregate reports failed to generate when the dataset contained one or more Cases with no primary Case Product.
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SAF-20947 |
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Fixed an issue where the Cumulative Dose field was not auto-calculated after Case promotion from an Inbox Item, AER, or from the Case Compare Followup page.
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SAF-21083 |
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Fixed an issue where system performance was slow during the Promote to Case action.
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SAF-21262 |
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Fixed an issue where, when a migration user ran the E2B import to Imported Case action, an error message did not appear, nor did the system prevent the action.
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SAF-21295 |
August 26, 2021
Release Number: 21.2.0.2 | Build Number: 354
| Description |
Issue No. |
|
Fixed an issue where, when the inbound format on the E2B(R2) file and the Transmission Profile did not match, the generated E2B R2 ACK contained incorrect information for A.1.6, A.1.7, and B.1.9.
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SAF-20021 |
|
Fixed an issue where, when generating a PADER without a local datasheet set up, only the expectedness of the primary Case Adverse Event was considered in the PADER Summary of ADR from Postmarketing Sources report. Now, the report evaluates the expectedness on the Case Assessment for each Case Adverse Event.
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SAF-20439 |
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Fixed an issue with the unmasked and masked DSUR Interval Line Listings of Serious Adverse Reactions where the generated report did not include the latest version for a downgraded (serious to non-serious) Case.
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SAF-20464 |
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Fixed an issue with manual and AS2 import where, when an E2B(R2) file with Origin ID set to MHRAUK was imported, the Origin field was not populated on the Inbound Transmission if the Destination ID fields from the E2B file and transmission profile did not match.
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SAF-20843 |
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Fixed an issue where, when a Japanese MedDRA term containing more than one character was searched for, the search did not return any results.
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SAF-21109 |
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Fixed an issue where, when promoting cases in bulk, duplicate Cases were sometimes created from an AER if multiple operations tried to promote the same AER.
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SAF-21288 |