SafetyDocs Feature Enablement Overview

Learn how to update your Vault’s configuration to enable SafetyDocs features.

When Safety Suite releases an update, new features may require changes to your Vault’s configuration to be available to end users. The following sections provide information for administrators to make features available for use:

• Enable PSMF Features
• Enable Literature Features
• Enable PVA Features
• Enable Signal Management Features
• Enable Aggregate Reporting Features
• Enable Risk Management Features

Enable PSMF Features

Release Added or Changed	Feature
24R2	PSMF Version Binding Validation
24R2	Order PSMF Logbook by Section/Annex
24R1	Exclusion of Obsolete Documents from the PSMF PDF
24R1	PSMF Document Deletion
23R3	PSMF Automatic Logbook Generation
23R3	Automatic Generation of PSMF Documents from Vault Reports
23R2	PSMF Periodic Reviews
23R2	PSMF Version Binding

Enable Literature Features

Release Added or Changed	Feature
25R2 Updated	Literature Review Process Management
25R1	Literature Integration to PubMed
25R1	Literature Abstract Translation
25R1	Importing Literature References from Databases
24R3	Literature Multi-Product Support
24R3	Create Inbox Items from Literature Articles in CRO Vaults
24R3	Literature Coding to Product Family
24R2	JAPIC Literature Intake
24R1	Creation of Inbox Items from Literature Articles

Enable PVA Features

Release Added or Changed	Feature
25R1	PVA Scheduling
25R1	PVA Management
24R3	Customize Sender Email Address for PVA Document Distribution
24R1	PVA Document Distribution via Vault Task
24R1	PVA Document Distribution via Email

Enable Signal Management Features

Release Added or Changed	Feature
25R2 New	Multiple Product Families on Safety Investigations
24R3	Open Safety Investigations from Literature Articles
24R3	Capture Additional Information for Safety Investigations
24R3	Add MedDRA Terms and Queries for Safety Investigations
24R2	Code Product-Event Combinations to MedDRA Queries
24R2	Create Safety Investigations from PEC Periods
24R2	Signal Management

Enable Aggregate Reporting Features

Release Added or Changed	Feature
25R2 New	Literature Inclusion in Aggregate Reports
24R2	Partner Distribution Tracking and Generate Final Aggregate Report ZIP
24R1	Generating Tabulations Using Aggregate Report Sections in SafetyDocs
24R1	Aggregate Report Management

Enable Risk Management Features

Release Added or Changed	Feature
24R3	Risk Management