21R1 Maintenance Releases

A maintenance release contains fixes for issues that affect customers in production environments.

Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.

A maintenance release contains fixes for issues affecting customer Vaults. Maintenance releases can occasionally include enhancements, for example, a time-sensitive regulatory requirement.

We communicate 24 hours prior to a maintenance release when there will 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.

The contents is subject to change until the release occurs. When we identify items for 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 an update early enough for full testing. In situations like this, we postpone the update for a later release and strike out the description in this list.

Veeva frequently delivers maintenance releases for the Vault Platform. Vault Safety deploys these Vault Platform maintenance releases at a later date. For details on the Vault Platform fixes in these maintenance releases, see Vault 21R1 Maintenance Releases.

August 2021

August 1, 2021

Release Number: 21.1.0.13 | Build Number: 682

Category Issue Description Issue No.
Vault Safety
Aggregate Reporting: DSUR Fixed an issue where the DSUR Appendix: Cumulative Summary Tabulation of SARS was including unrelated serious adverse events in the report. SAF-20205
Aggregate Reporting: DSUR 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
Aggregate Reporting: DSUR 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

July 2021

July 22, 2021

Release Number: 21.1.0.12 | Build Number: 673

Category Issue Description Issue No.
Vault Safety
Case Processing: Auto-Calculation Fixed an issue where the Cumulative Dose was not calculated correctly on the Case Product. SAF-18289
Case Processing: Auto-Expectedness 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
Transmissions: Gateway Transmissions 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

Category Issue Description Issue No.
Vault Safety
Intake: E2B Import Fixed an issue where partial dates were not accepted for the Date of Death field (D.9.1) on E2B(R3) import. SAF-18560
Intake: E2B Import Fixed an issue where a conflict warning appeared during E2B import when some Case Assessment Results were left blank or null. SAF-18389
Intake: E2B Import Fixed an issue where an ACK from Health Canada could not link to the Transmission record in the user's Vault. SAF-19091
Intake: E2B Import 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
Intake: Duplicate Detection 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
Case Processing: Follow-Ups Fixed an issue where E2B-imported Follow-Up Cases were not tagged with a Case Tag or Watchlist Tag. SAF-16825

July 8, 2021

Release Number: 21.1.0.10 | Build Number: 640

Category Issue Description Issue No.
Vault Safety
Intake: E2B Import 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
Intake: E2B Import 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
Intake: Duplicate Detection Fixed an issue where duplicate detection did not find any potential matches for Cases with matching Worldwide UIDs. SAF-16097

June 2021

June 29, 2021

Release Number: 21.1.0.9 | Build Number: 605

Category Issue Description Issue No.
Vault Safety
Case Processing: Narratives Fixed an issue where the Narrative Preview field was left blank on Imported Cases even when the narrative document was created. SAF-18799
Transmission: E2B Validation 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
Transmission: Reporting Rules 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
Transmission: Gateway Transmissions Fixed an issue where AS2 gateway communication failed when the external gateway required the entire SSL Certificate Trust Chain. SAF-18760
System: Object Administration 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

June 17, 2021

Release Number: 21.1.0.8 | Build Number: 563

Category Issue Description Issue No.
Vault Safety
Intake: E2B Import Fixed an issue where two Inbound Transmissions were generated for a single E2B file during manual import. SAF-18050
Transmission: E2B Validation 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
Transmission: E2B Validation 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
Vault Safety.AI
Intake: Verification 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

Category Issue Description Issue No.
Vault Safety
Case Processing: Data Entry Fixed an issue by increasing the number of decimal places for Case Product Substances and Study Product Substances. SAF-17884
Case Processing: Data Entry 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
Report Generation: CIOMS 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
Vault Safety.AI
Case Processing: Data Entry 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

May 2021

May 27, 2021

Release Number: 21.1.0.6 | Build Number: 495

Category Issue Description Issue No.
Vault Safety
Coding: MedDRA Fixed an issue with local MedDRA dictionary imports where LLT term and code fields were left blank when importing a MedDRA record. SAF-17710
Coding: MedDRA Fixed an issue where duplicate MedDRA records were created when updating local MedDRA to a new version. SAF-17476,
SAF-17449
Case Processing: Data Entry Fixed an issue where some EMA-supported units of measurement were unavailable in Vault Safety. SAF-10756,
SAF-17995

May 20, 2021

Release Number: 21.1.0.5 | Build Number: 471

Category Issue Description Issue No.
Vault Safety
Aggregate Reporting: PADER 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
Aggregate Reporting: DSUR Fixed an issue where the DSUR Interval Line Listings report was being generated with the incorrect file tab name. SAF-17286
Intake: E2B Import 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
Intake: E2B Import 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
Transmissions: Email Distributions Fixed an issue where the system was not populating certain tokens in the created Email Distribution. SAF-17637
Vault Safety.AI
System: Audit Log 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

Category Issue Description Issue No.
Vault Safety
Report Generation: CIOMS I/FDA 3500A 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
Intake: E2B Import 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
Intake: E2B Import Fixed an issue where a Case was being blind protected even when there was no blinded study in the Library. SAF-17077
SAF-17051
Intake: E2B Import Fixed an issue where A.1.3, ICSR Message Sender ID, was not mapped in the generated ACKs. SAF-17431
Coding: MedDRA/WHODrug Fixed an issue where a server error appeared when a user with Business Admin permissions tried to navigate to the Dictionary page. SAF-17265
System: Security Fixed an issue where migration failed in a Vault without Safety Management enabled. SAF-16652

May 6, 2021

Release Number: 21.1.0.3 | Build Number: 419

Category Issue Description Issue No.
Vault Safety
Transmissions: Submissions Fixed an issue where the blind protected case narrative was generated in the E2B(R2) submission instead of the updated case narrative. SAF-17047
Intake: E2B Import Fixed an issue where the Assessment Results were not imported from the E2B(R2) XML file. SAF-17032
Intake: E2B Import Fixed an issue where the Case Assessment Results were not created after importing the E2B file and promoting it to Case. SAF-16018
Intake: E2B Import Fixed an issue where an incorrect failure notification appeared for manual E2B imports. SAF-17310
Intake: E2B Import 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
Intake: Case Promotion 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
Case Processing: Data Entry Fixed an issue where, if one record failed when updating records in batch, all the records in the batch failed. SAF-17501
Coding: MedDRA 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
Report Generation: E2B Export 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
Report Generation: E2B Export 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
Report Generation: CIOMS I/FDA 3500A 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
Vault Safety.AI
Intake: E2B Import 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

April 2021

April 30, 2021

Release Number: 21.1.0.2 | Build Number: 393

Category Issue Description Issue No.
Vault Safety
Transmissions: E2B Validation 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
Transmissions: E2B Validation 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
Transmissions: E2B Validation 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
Transmissions: E2B Validation 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
Transmissions: E2B Validation Fixed an issue where Substance TermID and TermID Version always passed the FDA.G.k.2.3.r.2a validation rule. SAF-16407
Transmissions: E2B Validation 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
Intake: E2B Import 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
Intake: E2B Import 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
Intake: E2B Import Fixed an issue where some sections in ACK were missing when a single E2B file was not imported with errors. SAF-16971
Intake: E2B Import 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
Intake: E2B Import Fixed an issue where the Inbound Transmission Origin field was not being set by the source document's Origin field. SAF-17467
Case Processing: Watchlists 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
System: Lifecycles & Workflows 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

20R3 Maintenance Releases
21R2 Maintenance Releases