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 20R2 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 20R2.0, so our maintenance releases for this version are 20R2.0.2, 20R2.0.3, 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 20R2 Maintenance Releases.
Last Updated: August 12, 2022
December 3, 2020
Release Number: 20.2.0.13 | Build Number: 551
| Description |
Issue No. |
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Fixed an issue where incorrect Code System Version (CSV) values were being populated in system-generated E2B R3 files, resulting in ACK errors. To comply with ICH guidelines, E2B R3 files are now formatted with the latest CSV values.
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SAF-12374 |
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Fixed an issue where E2B files failed to generate when placeholder literature documents had the Retransmit field set to Yes.
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SAF-12664 |
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Fixed an issue where empty patient and parent sections were included in system-generated EMA E2B R3 files. To comply with EMA specifications, if patient or parent information is not provided, the empty sections are now omitted from generated EMA E2B R3 files.
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SAF-12865 |
Fixed an issue where, when a Case Test Result contained two or more of the below three values, all values were included in exported EMA E2B R3 files:- Test Result (code) (F.r.3.1)
- Test Result Value (F.r.3.2) or Test Result (unit) (F.r.3.3)
- Result Unstructured Data (F.r.3.4)
To comply with EMA specifications, only one of these values are now included in the message. Priority is given to structured data over free text.
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SAF-12867 |
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Fixed an issue where a Test Result "Normal Low Value" (F.r.4) and "Normal High Value" (F.r.5) were being exported as text in E2B R3 files. To comply with ICH guidelines, these elements will now be transmitted as numeric values.
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SAF-12919 |
November 19, 2020
Release Number: 20.2.0.12 | Build Number: 546
| Description |
Issue No. |
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Fixed an issue where documents that were placeholders or had no content were not being included in E2B (R3) generation despite being marked for Retransmit. The title and description of such documents will now be included in E2B (R3) exports in the Documents Held by Sender field.
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SAF-12210 & SAF-12208 |
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Fixed an issue where combination products and their device constituents were not being imported properly from E2B files. Vault Safety now supports reporting of combination products by including the Product Reported and Lot Number fields for device components in E2B (R3) imports for the EMA.
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SAF-12278 |
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Fixed an issue where combination products and their device constituents were not being mapped properly for EMA E2B (R3) reports. Vault Safety now supports reporting of combination products by including the Product Reported and Lot Number fields for device components in E2B (R3) exports to the EMA.
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SAF-12289 |
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Fixed an issue where Age and Age Group were being included in EMA E2B exports even when a complete Date of Birth was provided. To comply with ICH guidelines, Age and Age Group information will now only be included in EMA E2B exports if Date of Birth information is incomplete.
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SAF-12341 |
November 12, 2020
Release Number: 20.2.0.11 | Build Number: 540
| Description |
Issue No. |
|
Fixed an issue where EMA ELISA, ELU, and hp_X Units of Measurement were not provisioned. These Units of Measurement have now been provisioned. Note that the new units are only applicable to EMA, but all users will be able to see them in their vaults.
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SAF-11735 & SAF-10892 |
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Fixed an issue where Case Medical History Text was not being imported or exported in the correct format for EMA E2B files.
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SAF-12262 |
October 29, 2020
Release Number: 20.2.0.10 | Build Number: 537
| Description |
Issue No. |
|
Fixed an issue where if the Frequency number was 6, it was being incorrectly rounded off to 5 on Sections 15 and 22 of CIOMS I forms.
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SAF-11645 |
October 14, 2020
Release Number: 20.2.0.9 | Build Number: 536
| Description |
Issue No. |
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Fixed an issue where Reason Omitted values for Batch/Lot numbers were not being mapped to Vault during E2B (R3) Import.
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SAF-11358 & SAF-10687 |
October 8, 2020
Release Number: 20.2.0.8 | Build Number: 535
| Description |
Issue No. |
|
Fixed an issue where some configurations were allowing child records to be added to Superseded Cases.
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SAF-7599 |
September 24, 2020
Release Number: 20.2.0.7 | Build Number: 1095
| Description |
Issue No. |
|
Fixed an issue where E2B exports from a Transmission record did not consider the Expedited field on the Transmission record when populating the Does This Case Fulfill the Local Criteria for an Expedited Report? data element.
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SAF-10480 |
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Fixed an issue where Follow-Up Cases could not be created if the Case contained a Facility-type Case Contact that was selected in the Administration Facility field on the Case Product Dosage.
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SAF-10548 |
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Fixed an issue where a warning about the Dose Form value being truncated was appearing when generating E2B (R3), EMA E2B (R3), and FDA VAERS E2B (R3) files.
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SAF-10578 |
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Fixed an issue where, if Dosage Frequency was not entered, a warning about a non-standard frequency being entered was appearing when generating E2B (R2) files.
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SAF-10585 |
September 17, 2020
Release Number: 20.2.0.6 | Build Number: 1050
| Description |
Issue No. |
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Fixed an issue where Follow-Up Cases could not be created from the Potential Matches page if the original Case had both Reporter and Sender Case Contacts listed.
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SAF-9419 |
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Fixed an issue where Parent Gender was not being exported in Masked E2B (R3) files.
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SAF-10272 |
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Fixed an issue where the file name was being populated in an incorrect format when auto-generating E2B (R2), (R3), and FDA E2B (R2) files through a Transmission.
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SAF-10472 |
September 10, 2020
Release Number: 20.2.0.5 | Build Number: 983
| Description |
Issue No. |
|
Fixed an issue where PSUR line listings failed to generate with a large data set.
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SAF-9311 |
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Fixed an issue where after creating a Follow-Up Case from an initial Case in the Closed state, Case descendant objects did not transition to the Active state.
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SAF-9589 & SAF-9469 |
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Fixed an issue where AERs could not be promoted to Cases when the AER Report Type was Study, the Study was double-blinded, and the Study Product was external (not in the product library).
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SAF-9893 |
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Fixed an issue where Inbound Transmissions received through AS2 Gateway failed to return an ACK to the sender.
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SAF-10114 |
August 28, 2020
Release Number: 20.2.0.4 | Build Number: 887
| Description |
Issue No. |
|
Fixed an issue with E2B file generation where data element B.4.k.7 was set to blank when only the Dose Form Term ID field was populated.
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SAF-9267 |
August 20, 2020
Release Number: 20.2.0.3 | Build Number: 791
| Description |
Issue No. |
|
Fixed an issue causing the page load time for Cases to be extended.
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SAF-9461 |
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Fixed an issue where an error appeared when selecting “Keep blinded” during an unblinding task for a Case.
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SAF-9617 |
August 18, 2020
Release Number: 20.2.0.2 | Build Number: 788
| Description |
Issue No. |
|
Fixed an issue where after creating a Follow-Up Case from an initial Case in the Closed state, all Case descendant objects remained in the Closed state and could not be edited.
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SAF-9570 |