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.
This list only covers fixes for issues that impact 25R1 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 Veeva Vault General Release is 25R1.0, so our maintenance releases for this version are 25R1.0.2, 25R1.0.3, and so on.
Veeva 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 25R1 Maintenance Releases.
Last Updated: May 9, 2025
May 13, 2025
Release Number: 25R1.0.5 | Build Number: TBD | Platform: TBD
| Description | Issue No. |
|---|---|
| When generating PMDA E2B(R3) files, in some instances, Vault names files using more than 60 characters and cover letters using more than 100 characters, resulting in NACKS from the PMDA. | SAF-77146 |
| In Vaults with the "Use Product Coded for HC E2B(R2)" Submission and Distribution Settings application setting enabled, when generating Health Canada E2B(R2) files, Vault exports the Product (Coded) value from External Products to the B.4.k.2.1 data element, resulting in NACKs from Health Canada. | SAF-77437 |
| When generating EU Convention E2B(R2) files with Patient Content Protection set to Mask PII, Vault does not apply masking correctly, which sometimes results in NACKs. | SAF-77512 |
| When an Inbox Item with a Localization value is being merged to an in-flight Case or promoted to a follow-up Case and is matched to a global Case, if two (2) or more Case Products are being deleted, Vault displays an error message and prevents the action. | SAF-77846 |
| When generating an MFDS E2B(R3) file for a domestic study Case with a value in the Local Assessment Result field on the Localized Case Assessment Result, Vault populates an E2B code in the G.k.9.i.2.r.3.KR.1 data element. | SAF-77880 |
| FDA E2B(R3) generation fails for Cases with attachments in the .docx format. | SAF-77883 |
| Vault does not generate CIOMS I Distributions for Cases with multiple Case Test Result records when at least one (1) includes a partial date in the Test Date field. | SAF-77924 |
| When generating E2B(R2) formats, Vault exports more than five (5) characters to the B.4.k.13.1a and B.4.k.13.2a data elements, resulting in NACKs. | SAF-78049 |
| If any Inbox Item or Case that generates email correspondence is missing a Reporter-type Case Contact, Vault cannot send any scheduled email correspondence. | SAF-78091 |
May 6, 2025
Release Number: 25R1.0.4 | Build Number: 286 | Platform: 10547
| Description | Issue No. |
|---|---|
| When promoting an Inbox Item with invalid data to multiple Cases, Vault creates a single Case with no Case Number. Upon further investigation this fix was included in 25R1.0.3 | SAF-76061 |
| When creating a new Case using the Copy Case action, Vault does not populate the Case Unique Number field. | SAF-76549 |
| When creating a domestic follow-up Case to a global initial Case, Vault leaves the Use Domestic State Code checkbox unselected, resulting in the text value instead of the state code being exported for the State/Province field. | SAF-76587 |
| When creating a domestic follow-up Case to a global initial Case with unblinded Products, Vault creates duplicate records on the follow-up Case, requiring users to delete these records manually. | SAF-77598 |
| When the A.2.2 or C.4.r.1 Literature Reference(s) data element exceeds 500 characters, Vault does not truncate the value, resulting in NACKs from agencies. | SAF-77604 |
| Transmission documents are not generated for Submissions to Health Canada as HC E2B(R2) files are not validated due to a missing Document Type Definition (DTD). | SAF-77884 |
| When generating FDA E2B(R3) files, validation fails when the FDA.C.5.5a IND Number where AE Occurred data element is populated and the associated Transmission Profile is a postmarket CDER or CBER. | SAF-78067 |
| For Product Registrations with a Registration Applicant/Holder value that exceeds 60 characters, Vault prevents saving the related Case Product on a domestic Case because the number of characters cannot be mapped to the same field on the Localized Case. | SAF-78265 |
April 30, 2025
Release Number: 25R1.0.3 | Build Number: 278 | Platform: 10547
| Description | Issue No. |
|---|---|
| This update optimizes code for lifecycle state changes. This will be available for configuration in a future release. | SAF-77832 SAF-78311 SAF-78312 SAF-78315 |
| When promoting an Inbox Item with invalid data to multiple Cases, Vault creates a single Case with no Case Number. | SAF-76061 |
| When generating Transmissions from Transmission Output Templates that include a Reporting Family, Vault considers the Exceptions to PII Masking field of the related reporting rule parameter instead of the Exceptions to Patient Content Protection field on the Transmission Output Template. | SAF-77878 |
| In Vaults configured to isolate blinded clinical trial information and with the Exclude reporting rule parameter set to Placebo, for a double-blinded study Case with an unblinded Case Product record for the Placebo, the reporting rule engine evaluates the blinded record instead of the unblinded record. | SAF-77879 |
| In some instances, Vault does not create any Correspondence records due to an exceedingly large number of MedDRA Criteria object records with the Include Lower Level field set to Yes. | SAF-78204 |
| When generating FDA E2B(R3) and FDA VAERS E2B(R3) reports, if both the Race and Ethicity fields are populated and at least one (1) has a Reason Omitted value, Vault either leaves the FDA.D.12 Patient Ethnicity Code data element blank or exports the Race nullFlavor to it. | SAF-78194 |
April 23, 2025
Release Number: 25R1.0.2 | Build Number: 250 | Platform: 10481
| Description | Issue No. |
|---|---|
| In Vaults with the "Suppress File Generation for Auto-Submit Transmissions" application setting enabled, for Email Profile-type Transmission Profiles with Auto-Submit set to "Yes", after running the Case-level "Async Submit to Gateway" action, the Transmission remains in the "Queued for Submission" state and no Submission document is generated. | SAF-78134 |