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 19R3 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 19R3.0, so our maintenance releases for this version are 19R3.0.2, 19R3.0.3, 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 19R3 Maintenance Releases.
Last Updated: December 12, 2022
March 31, 2020
Release Number: 19R3.0.11 | Build Number: 943
| Description | Issue No. |
|---|---|
| Fixed an issue where Narrative Text was being cut off in the overflow page of Section 7+13 of CIOMS I forms. | SAF-5198 |
March 11, 2020
Release Number: 19R3.0.10 | Build Number: 898
| Description | Issue No. |
|---|---|
| Fixed an issue where the Initial Reporter's address was being cut off in Section E.1 of FDA 3500A forms. | SAF-3721 |
| Fixed an issue where the name of the Manufacturer/Compounder was being cut off in Section G.1 of FDA 3500A forms. | SAF-3722 |
| Fixed an issue where Product Dosages and Indications were being cut off when they exceeded field character limits in Section C of 3500A forms. Additional information will now be mapped onto an overflow page. | SAF-3724 |
| Fixed an issue where information was not overflowing onto additional pages when it exceeded field character limits in FDA 3500A forms. | SAF-3794 |
| Fixed an issue where the Manufacturer Report Number was being cut off if it exceeded 20 characters in Section G.9 of FDA 3500A forms. | SAF-4061 |
| Fixed an issue with follow-up transmission records where the Receipt Date was being used to calculate the Due Date even when a New Info Date was entered. | SAF-4079 |
| Fixed an issue where footers were not up to date with the newest version of the CIOMS I form. Footers will now display the date and time of report generation as well as the case version. | SAF-4344 |
| Fixed an issue where Sender’s Comments were not appearing at the end of Section B.5 or its overflow field on FDA 3500A forms. | SAF-4407 |
| Fixed an issue where, when multiple dosages were entered, only one was being populated onto Section C.2 of FDA 3500A forms. | SAF-4412 |
| Fixed an issue where Dose Text was not being populated in Sections C.2 and C.3 of FDA 3500A forms. | SAF-4467 |
| Fixed an issue where fields were not overflowing onto an additional page when they exceeded their character limits in Section 22 of CIOMS I forms. | SAF-4544 |
| Fixed an issue where text in overflow fields was not being indented when it exceeded one line. | SAF-4554 |
| Fixed an issue where Suspect and Concomittant Products were being cut off when they exceeded field character limits in Section C of 3500A forms. Multiple products will now be listed in repeated sections, and additional information will be mapped onto an overflow page. | SAF-4661 |
March 2, 2020
Release Number: 19R3.0.9 | Build Number: 870
| Description | Issue No. |
|---|---|
| Fixed an issue where only primary suspect drugs, doses, indications, and RoAs were appearing in Section II of CIOMS I forms. | SAF-3723 |
| Fixed an issue where the full name and address of the manufacturer was not appearing in Section 24a of CIOMS I forms. | SAF-3735 |
| Fixed an issue where Section 25b detailing Reporter Information was missing from CIOMS I forms. | SAF-3774 |
| Fixed an issue where page breaks appeared in between sections on the overflow page of CIOMS I forms. Overflow sections will now flow continuously with standard line and paragraph spacing. | SAF-3783 |
| Fixed an issue where additional seriousness criteria and multiple doses, indications, and RoAs were not being populated on CIOMS I forms. The form has now been updated with these additions and the layout has been adjusted to increase clarity. | SAF-3790 |
| Fixed an issue with E2B imports where the most recent New Info Date was not being mapped onto the Date Received by Manufacturer field on CIOMS I and FDA 3500A forms. | SAF-4106 & SAF-4105 |
| Fixed an issue where test results were not being displayed in order in Section 7+13 of CIOMS I forms. Test results will now be sorted alphabetically and from oldest to latest in both Section 7+13 and its overflow page. | SAF-4288 |
| Fixed an issue where test results were not being displayed in order in Section B6 of FDA 3500A forms. Test results will now be sorted alphabetically and from oldest to latest in both Section B6 and its overflow page. | SAF-4290 |
| Fixed an issue where patient's weight was not being mapped onto Section 3a of CIOMS I forms. | SAF-4305 |
| Fixed an issue where fields were not overflowing onto additional pages when they exceeded permissible character limits on CIOMS I forms. | SAF-4337 & SAF-3792 |
| Fixed an issue where footers were not up to date with the newest version of the CIOMS I form. Footers will now display the date and time of report generation as well as the case version. | SAF-4344 |
| Fixed an issue where Sender’s Comments were not appearing in the overflow field of Section 7+13 on CIOMS I forms. | SAF-4405 |
| Fixed an issue where dosage text was not being mapped onto Section 15 of CIOMS I forms. | SAF-4406 |
| Fixed an issue where a field label was misspelled on CIOMS I forms. | SAF-4417 |
| Fixed an issue where auto-calculated whole number values for Therapy Duration were appearing with decimal places in Section 19 of CIOMS I forms. | SAF-4460 |
| Fixed an issue where the continued sign (...) was appearing at the end of the second last line rather than the last line of Section 7+13 on CIOMS I forms. | SAF-4491 |
| Fixed an issue where the continued sign (...) was not appearing when the text in Section 1 of CIOMS I forms exceeded the permissible character limit. | SAF-4502 |
| Fixed an issue where the continued sign (...) was not appearing when the text in Section 25b of CIOMS I forms exceeded the permissible character limit. | SAF-4503 |
| Fixed an issue where overflow formatting was not appearing correctly when indications, RoAs, or dosages exceeded their permissible character limits on CIOMS I forms. | SAF-4504 |
| Fixed an issue where the continued sign (...) was not appearing when the text in Section 24b exceeded the permissible character limit, and a double border was appearing on the overflow page of CIOMS I forms. | SAF-4540 |
| Fixed an issue where, when multiple medical history records were included, the continued sign (...) was appearing at the end of the second last line rather than the last line of Section 23 on CIOMS I forms. | SAF-4545 |
| Fixed an issue where dates were being inconsistently formatted in Section 24c of CIOMS I forms. | SAF-4574 |
| Fixed an issue where the continued sign (...) was being cut off when Dose text exceeded the permissible character limit in Section 15 of CIOMS I forms. | SAF-4582 |
February 13, 2020
Release Number: 19R3.0.8 | Build Number: 803
| Description | Issue No. |
|---|---|
| Fixed an issue where test result ranges were not appearing in Section B6 of FDA 3500A forms and Section 7+13 of CIOMS I forms if data was entered in the Result (text) field. | SAF-3959 & SAF-3964 |
| Fixed an issue where codes were being populated instead of simplified descriptors when users selected Reason Omitted values for Start and End dates on FDA 3500A and CIOMS I forms. | SAF-4005 |
January 30, 2020
Release Number: 19R3.0.7 | Build Number: 769
| Description | Issue No. |
|---|---|
| Fixed an issue so that the patient’s age in Section 2a is populated with the patient’s age group if no other age details are available on CIOMS I forms. | SAF-3741 |
| Fixed an issue where, in the absence of information about the product being compounded, Section C.6 was populated with No on FDA 3500A forms. | SAF-3867 |
| Fixed an issue where incorrect report type checkboxes were populated for SAEs and Serious Cases on FDA 3500A forms. | SAF-3879 |
| Fixed an issue where the initial Receipt Date instead of the New Info Date was mapped to Section G.4 on FDA 3500A forms. | SAF-3957 |
| Fixed an issue where the initial Receipt Date instead of the New Info Date was mapped to Section 24c on CIOMS I forms for Follow-Up Cases. | SAF-3961 |
| Fixed an issue where Dose amounts in Sections C.2 and C.3 were being rounded off on FDA 3500A forms. | SAF-4009 |
| Fixed an issue where the patient’s weight in Section A.4 was being rounded off on FDA 3500A forms. | SAF-4013 |
January 20, 2020
Release Number: 19R3.0.6 | Build Number: 723
| Description | Issue No. |
|---|---|
| Fixed an issue where the Foreign checkbox was filled in section G.3 on the FDA 3500A form when the reporter country was blank on the Case. | SAF-3467 |
| Fixed an issue where product registration numbers were populated in section C.1 on the FDA 3500A form. | SAF-3720 |
| Fixed an issue where blank dates were populated as question marks (???) on FDA 3500A and CIOMS I forms. To improve clarity, blank dates are now populated as dashes (---). | SAF-3727 SAF-3726 |
| Fixed an issue where the Foreign checkbox was filled in section G.3 on the FDA 3500A form when the reporter country was blank on the Case. | SAF-3729 |
| Fixed an issue where the reported (verbatim) event text was not populated before the MedDRA term on the FDA 3500A form. | SAF-3730 |
| Fixed an issue where the reported (verbatim) event text and the MedDRA term for adverse events were not populated at the start of section 7+13 on the CIOMS I form. | SAF-3731 |
| Fixed an issue where calculated ages were populated as a decimal number instead of a whole number on the FDA 3500A and CIOMS I forms. | SAF-3732 |
| Fixed an issue where the global manufacturer name and address were not populated on FDA 3500A and CIOMS I forms when generated to preview the Case. This issue did not affect FDA 3500A and CIOMS I forms generated for Distributions and Submissions. | SAF-3736 |
| Fixed an issue where concomitant product generic names were not populated on the FDA 3500A and CIOMS I forms. | SAF-3738 |
| Fixed an issue where, during an E2B import, an assessment method and result were used to populate two Case Assessments when the second assessment was missing the method and result. | SAF-3740 |
| Fixed an issue where product registration numbers were populated in Section 14 on the CIOMS I form. | SAF-3775 |
January 10, 2020
Release Number: 19R3.0.5 | Build Number: 658
| Description | Issue No. |
|---|---|
| Fixed an issue where a trailing space or double space in the Product (Reported) field caused issues with automatically populating and running the WHODrug search query. | SAF-3337 |
| Fixed an E2B import issue where the Case Receipt Date was set to the date when the E2B file was uploaded instead of mapping the Date of Creation from the E2B file. | SAF-3458 |
| Fixed an issue where generating multiple Transmission records for the same Case, such as a Submission and a Distribution, sometimes lead to the same E2B file being attached to each Transmission. | SAF-3498 |
December 18, 2019
Release Number: 19R3.0.4 | Build Number: 605
| Description | Issue No. |
|---|---|
| Fixed an issue where unblinded Cases with blind-protection enabled were not counted in DSUR or PBRER aggregate reports. | SAF-3403 & SAF-3394 |
| Fixed an issue where if the Study Blinded field was not set to a value (Yes or No), the Case was not counted in DSUR or PBRER aggregate reports. | SAF-3466 |