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 21R1 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 21R1.0, so our maintenance releases for this version are 21R1.0.1, 21R1.0.2, 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 21R1 Maintenance Releases.
Last Updated: December 12, 2022
August 1, 2021
Release Number: 21.1.0.13 | Build Number: 682
| Description | Issue No. |
|---|---|
| Fixed an issue where the DSUR Appendix: Cumulative Summary Tabulation of SARS was including unrelated serious adverse events in the report. | SAF-20205 |
| Fixed an issue with the DSUR Cumulative Tabulation of Serious Adverse Events from Clinical Trials report where, when a Case was downgraded from Serious to Non-Serious, the report did not display the latest Case version within the reporting period. | SAF-20231 |
| Fixed an issue with the unmasked DSUR Cumulative Tabulation of Serious Adverse Events from Clinical Trials report where the same adverse event could be counted in both the Blinded and Placebo columns when there are multiple versions of the Case. | SAF-20353 |
July 22, 2021
Release Number: 21.1.0.12 | Build Number: 673
| Description | Issue No. |
|---|---|
| Fixed an issue where the Cumulative Dose was not calculated correctly on the Case Product. | SAF-18289 |
| Fixed an issue with central MedDRA where the generated auto-expectedness didn't adhere to the Include Lower Levels option on the Local Datasheet. This resulted in the Expectedness field being incorrectly populated on the Expectedness record. | SAF-19406 |
| Fixed an issue where asynchronous MDNs were not sent after receiving an ICSR through the AS2 gateway. This resulted in the same ICSR being resent and duplicate AERs being created. A temporary configuration fix was deployed last week for a customer who experienced this issue. This maintenance release deploys a permanent fix for all Safety customers. | SAF-19759 |
July 15, 2021
Release Number: 21.1.0.11 | Build Number: 661
| Description | Issue No. |
|---|---|
| Fixed an issue where E2B-imported Follow-Up Cases were not tagged with a Case Tag or Watchlist Tag. | SAF-16825 |
| Fixed an issue where a conflict warning appeared during E2B import when some Case Assessment Results were left blank or null. | SAF-18389 |
| Fixed an issue where, after promoting an AER to Case and specifying it as a Follow-Up Case during duplicate detection, a duplicate Reporter Case Contact record was created. | SAF-18442 |
| Fixed an issue where partial dates were not accepted for the Date of Death field (D.9.1) on E2B(R3) import. | SAF-18560 |
| Fixed an issue where E2B imports were failing due to an intermittent conflict with Vault rendition processes. Document renditions will now be suppressed during the E2B import process and will generate once a user views the document. | SAF-18902 |
| Fixed an issue where an ACK from Health Canada could not link to the Transmission record in the user's Vault. | SAF-19091 |
July 8, 2021
Release Number: 21.1.0.10 | Build Number: 640
| Description | Issue No. |
|---|---|
| Fixed an issue where duplicate detection did not find any potential matches for Cases with matching Worldwide UIDs. | SAF-16097 |
| Fixed an issue where the Outcome field on the Case Adverse Event record was not populated with "Unknown" and was left blank when the E2B(R2) source file had an invalid code for B.2.i.8 (reactionoutcome). | SAF-18449 |
| Fixed an issue where, when an E2B file was imported manually or through the API to an AS2 Transmission Profile, the logs displayed a NullPointerException (NPE) error. | SAF-18759 |
June 29, 2021
Release Number: 21.1.0.9 | Build Number: 605
| Description | Issue No. |
|---|---|
| Fixed an issue with VAERS E2B(R3) validation where the FDA.FDA.D.2.1b-2 validation rule failed when a valid decade unit was entered. | SAF-17373 |
| Fixed an issue with the Localized Case data model to better support object hierarchy links (grandchildren records). New lifecycle states were also added to support Closed Localized Cases. The data model migration is auto-on and will not impact customers. | SAF-18358 |
| Fixed an issue where AS2 gateway communication failed when the external gateway required the entire SSL Certificate Trust Chain. | SAF-18760 |
| Fixed an issue where the Narrative Preview field was left blank on Imported Cases even when the narrative document was created. | SAF-18799 |
| Fixed an issue where the reporting rules engine did not generate Submissions when the Event Country did not match the Product or Study Registration Country, even if both countries share the same agency (such as EMA). | SAF-18881 |
June 17, 2021
Release Number: 21.1.0.8 | Build Number: 563
| Description | Issue No. |
|---|---|
| Fixed an issue with VAERS E2B validation where the Validation Result listed Autopsy Performed as a required field when the Date of Death field was left blank, set to a Reason Omitted, or masked. | SAF-16797 |
| Fixed an issue where two Inbound Transmissions were generated for a single E2B file during manual import. | SAF-18050 |
| Fixed an issue where the ICH.E.i.7 validation rule was missing at the Case level and Submission level for the EMA E2B(R3) file format. | SAF-18243 |
| Fixed an issue where, when the Drug Role field was set to Similar Device, "null" appeared in the Product header. | SAF-18490 |
June 3, 2021
Release Number: 21.1.0.7 | Build Number: 513
| Description | Issue No. |
|---|---|
| Fixed an issue where CIOMS submission section headers 7 and 13 were labelled as [LOWER LEVEL TERM] when PT (Preferred Term) was enabled. | SAF-17762 |
| Fixed an issue by increasing the number of decimal places for Case Product Substances and Study Product Substances. | SAF-17884 |
| Fixed an issue where if the Patient section was collapsed, after verifying the Date of Death validation error ("The date cannot be later than the Date of Death"), the user could not save the section and the error persisted. | SAF-18038 |
| Fixed an issue where the Strength field on Case Product Substances did not support decimals. This change is not auto-on in 21R1.0.7. Contact Managed Veeva Services to request this change in your Vault. | SAF-18268 |
May 27, 2021
Release Number: 21.1.0.6 | Build Number: 495
| Description | Issue No. |
|---|---|
| Fixed an issue where some EMA-supported units of measurement were unavailable in Vault Safety. | SAF-10756 & SAF-17995 |
| Fixed an issue where duplicate MedDRA records were created when updating local MedDRA to a new version. | SAF-17476 & SAF-17449 |
| Fixed an issue with local MedDRA dictionary imports where LLT term and code fields were left blank when importing a MedDRA record. | SAF-17710 |
May 20, 2021
Release Number: 21.1.0.5 | Build Number: 471
| Description | Issue No. |
|---|---|
| Fixed an issue where the DSUR Interval Line Listings report was being generated with the incorrect file tab name. | SAF-17286 |
| Fixed an issue where, when importing an E2B(R2) file, the Source field in the second generated Case Assessment Result was populated with Non Health Care Professional instead of being left blank. | SAF-17522 |
| Fixed an issue where the system was not populating certain tokens in the created Email Distribution. | SAF-17637 |
| Fixed an issue where, when importing an E2B(R2) file, Case Assessments and Case Assessment Results were created for non-suspect or concomitant Products. | SAF-17638 & SAF-17592 |
| Fixed an issue where Vaults that do not have the event_meddra_pt__c field were unable to generate the PADER Non-Primary Suspect Product Report. | SAF-17818 & SAF-17768 |
| Fixed an issue where encrypted Inbox Item field values were not shown in the audit trail. | SAF-17847 |
May 17, 2021
Object to Picklist Field Type Change
On May 17, 2021, all Units of Measurement and Reason Omitted fields on all objects are being changed from object-type to picklist-type fields.
See FAQ: Units of Measure and Reason Omitted Object Type to Picklist Change Control for details.
May 13, 2021
Release Number: 21.1.0.4 | Build Number: 454
| Description | Issue No. |
|---|---|
| Fixed an issue where the G.4 field on the FDA 3500A and CIOMS I form was populated with Receipt Date instead of New Info Date. | SAF-15725 & SAF-13197 |
| Fixed an issue where migration failed in a Vault without Safety Management enabled. | SAF-16652 |
| Fixed an issue where a Case was being blind protected even when there was no blinded study in the Library. | SAF-17077 & SAF-17051 |
| Fixed an issue where a server error appeared when a user with Business Admin permissions tried to navigate to the Dictionary page. | SAF-17265 |
| Fixed an issue where A.1.3, ICSR Message Sender ID, was not mapped in the generated ACKs. | SAF-17431 |
| Fixed an issue where an E2B file and Inbound Transmission could not be imported due to an invalid value on the Origin field. | SAF-17566 & SAF-17545 |
May 6, 2021
Release Number: 21.1.0.3 | Build Number: 419
| Description | Issue No. |
|---|---|
| Fixed an issue where the Case Assessment Results were not created after importing the E2B file and promoting it to Case. | SAF-16018 |
| Fixed an issue where the system generated another case_product_dosage record if the Dosage field values were the same between drug items in the imported E2B(R2) file. | SAF-16524 |
| Fixed an issue where the system generated duplicate MedDRA records when a user uploaded the same MedDRA version zip file locally more than once. | SAF-16997 |
| Fixed an issue where the Assessment Results were not imported from the E2B(R2) XML file. | SAF-17032 |
| Fixed an issue where the blind protected case narrative was generated in the E2B(R2) submission instead of the updated case narrative. | SAF-17047 |
| Fixed an issue so that transmissions no longer contain unblinded study information and submissions always include the most recent narrative in system-generated E2B(R2) files. | SAF-17074 |
| Fixed an issue so that transmissions no longer contain unblinded study information and submissions always include the most recent narrative in system-generated E2B(R3) files. | SAF-17147 |
| Fixed an issue so that transmissions no longer contain unblinded study information and submissions always include the most recent narrative in system-generated PDF forms (CIOMS I and FDA 3500A). | SAF-17150 |
| Fixed an issue where you could not promote AERs to Cases if there was an inactive custom Drug Role Controlled Vocabulary with an E2B code of 1 (suspect) in the Vault. | SAF-17288 |
| Fixed an issue where an incorrect failure notification appeared for manual E2B imports. | SAF-17310 |
| Fixed an issue where, when an E2B file containing a single ICSR was imported successfully, two Message Acknowledgments (ACKs) appeared, one of which incorrectly stated that the message could not be parsed (transmissionacknowledgementcode = 03). | SAF-17428 |
| Fixed an issue where, if one record failed when updating records in batch, all the records in the batch failed. | SAF-17501 |
April 30, 2021
Release Number: 21.1.0.2 | Build Number: 393
| Description | Issue No. |
|---|---|
| Fixed an issue where a warning was appearing for the ICH.D.7.1.r.6 validation rule when the parent and patient have different Medical History records. | SAF-16352 |
| Fixed an issue where Substance TermID and TermID Version always passed the FDA.G.k.2.3.r.2a validation rule. | SAF-16407 |
| Fixed an issue where the FDA.FDA.D.12-1 and FDA.FDA.D.11-1 validation rules failed for Ethnicity and Race with valid nullFlavors. | SAF-16554 |
| Fixed an issue where, if a case with Registration in U.S. had invalid nullFlavors, it passed the FDA.D.1*-3 validation rule. | SAF-16663 |
| Fixed an issue where a warning was not appearing for FDA VAERS validation rule FDA.FDA.D.8.r.8a when the Patient Age at Vaccination value exceeded three digits. | SAF-16672 |
| Fixed an issue where the DME watchlist tag was not updated on the case if the product has Registration in UK. | SAF-16815 & SAF-16747 |
| Fixed an issue where, when an E2B file containing multiple ICSRs was imported, if one of the cases resulted in an error, an Inbound Transmission for that single case was not generated. | SAF-16856 |
| Fixed an issue where, when a user selected "Re-evaluate Submission/Distribution" and completed the transmission error task on the generated submission record, the system skipped the current workflow and moved the Case to the next workflow. | SAF-16858 & SAF-16857 |
| Fixed an issue where the Vault object case_version_v was being used instead of case_drug_history_v for validation criterias FDA.FDA.D.8.r.8b-1 and FDA.FDA.D.8.r.8b-2. | SAF-16952 |
| Fixed an issue where some sections in ACK were missing when a single E2B file was not imported with errors. | SAF-16971 |
| Fixed an issue where the Last Dose Latency value was not populated on the Case from the imported E2B(R2) file. | SAF-17098 & SAF-16741 |
| Fixed an issue where system-generated E2B(R2) acknowledgment messages (ACKs) were not being populated with any value in the M.1.4 Message Number field. | SAF-17223 & SAF-17334 |
| Fixed an issue where the Inbound Transmission Origin field was not being set by the source document's Origin field. | SAF-17467 |