Veeva Vault Safety unifies pharmacovigilance systems and processes on a single cloud platform to deliver proactive patient safety. The common data model across the suite of applications enables easy collection, management, and real-time oversight of adverse events. Vault Safety is built on Vault and includes the Platform features described in Vault Help for Platform.
Vault Safety applications, including Vault Safety and Vault SafetyDocs, can be used alone or together within a single Vault. The Vault Safety Workbench and Vault Safety Signal applications can be used along with Vault Safety.
Vault Safety
Vault Safety is a modern application for the automation, collection, management, and real-time oversight of adverse events and safety content that offers the following features:
- End-to-end management of safety processes including intake, medical review, case processing, and submission of adverse events for clinical and marketed products
- A simple, intuitive, and collaborative user interface
- A single source of truth for real-time visibility of safety operational and compliance data and documents in one (1) platform
- Aggregate reporting features that support informed decisions and greater compliance
- Open APIs and technology integrations for a connected ecosystem
Vault Safety Signal
Vault Safety Signal is a modern application for signal detection for existing safety databases and includes the following features:
- Complies with a multitude of signal data sources.
- Custom business rules to determine the threshold for signal detection.
- Advanced statistical methods for robust calculations.
- Seamless integration with Vault Safety, Safety Workbench, and the Signal Management process employed by Vault SafetyDocs.
Vault Safety Workbench
Vault Safety Workbench is a modern application for complex reporting and data analysis on high volumes of Vault Safety data. This application uses a powerful OLAP database with a copy of the Vault Safety dataset, and includes the following features:
- Advanced safety views in SQL for complex queries and data manipulation
- Easy-to-use report configuration and generation
- Standard regulatory reports optimized for high volumes of data
- Data analysis through interactive dashboards
- Seamless integration with Vault Safety and SafetyDocs
Vault SafetyDocs
Vault SafetyDocs is a modern application that allows users to manage pharmacovigilance and other safety-related content, including the following features:
- Efficiencies gained through unified management of the following:
- Pharmacovigilance System Master File (PSMF)
- Pharmacovigilance agreements
- Literature
- Embedded automation of a Signal Management process based on GVP Module IX guidelines