Vault SafetyDocs
Vault SafetyDocs centrally manages safety content and pharmacovigilance documents for greater operational efficiency and compliance. Collaborate globally in teams, across organizations, or with partners.
Benefits
Improve Compliance
Detailed audit trail, version control, intuitive search capabilities, and real-time status visibility improves compliance for audits and inspections.
Enable Collaboration
Easily share content internally or externally and collaborate across quality, regulatory, clinical, safety, and other organizations.
Increase Efficiency
Intuitive solution that is easy to use and maintain for more effective pharmacovigilance document management.
Stay Current
Access new capabilities and the latest regulatory requirements with easy and automatic upgrades.
Features
Controlled Access
Securely enable internal and external users to access safety content and pharmacovigilance documents, and centrally manage pharmacovigilance (PV) agreements and pharmacovigilance system master file (PSMF) on any device from a major web browser. Users can only see and perform tasks based on their security role.
Version Control
Automate versioning and easily compare pharmacovigilance documents to previous versions to see how the safety content has changed.
Content Binders
Quickly organize documents with binders for the pharmacovigilance system master file (PSMF) or an inspection. And, link to source documents in the safety, quality, regulatory, clinical, or other Vaults to ensure a single source of truth for regulated content.A centralized structure, improves coordination of PSMF management and execution of audits.
Electronic Signature and Manifestation
Approve documents using electronic signatures and manifestations that are compliant with Title 21 CFR Part 11 and Annex 11.
Comprehensive Audit Trail
Demonstrate compliance with detailed audit trails capturing every event in a document’s history – including document approvers and reviewers, status changes, execution of a signature, and more.
Real-time Collaborative Authoring
Seamless integration between Vault and Microsoft Office Online provides real-time collaborative authoring and does so in a compliant way. See a demo.
Interactive Dashboards and Reports
Self-service reporting and dashboards enable users to see the status of content and processes, making it easy to identify bottlenecks or compliance risks. Click through the report for more detail or easily share information with your team or partners.
Document Taxonomy
Easily establish a document taxonomy and standard picklists for safety content and pharmacovigilance documentation to facilitate harmonization and collaboration of safety information across quality, regulatory, clinical, and other departments or organizations.
Configurable Workflows
Automatically route content for review and approval to align with business processes, and trigger workflows based on document expiration and periodic review notification.
Validation Ready
Veeva performs and documents all elements of Infrastructure Qualification (IQ) and Operational Qualification (OQ) for each major release. A sandbox / test environment and user acceptance testing (UAT) scripts are also provided that can be leveraged and adapted for Performance Qualification (PQ).
Resources on Content Management for Pharmacovigilance
