Veeva Vault SafetyDocs
Vault SafetyDocs centrally manages pharmacovigilance content for greater operational efficiency and compliance. It enables global collaboration within teams and across clinical, quality, regulatory, and other organizations.
- 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 document management.
CONTROLLED ACCESSSecurely enable internal and external users to access safety documents on any device from a major web browser. Users can only see and perform tasks based on their security role.
VERSION CONTROLAutomate versioning and easily compare documents to previous versions to see how the content has changed.
CONTENT BINDERSQuickly organize and manage documents with binders for the pharmacovigilance system master file (PSMF) or an inspection. Link to source documents in the safety, quality, regulatory, clinical, or other Vaults to ensure a single source of truth for regulated content.
ELECTRONIC SIGNATURE AND MANIFESTATIONApprove documents using electronic signatures and manifestations that are compliant with Title 21 CFR Part 11 and Annex 11.
COMPREHENSIVE AUDIT TRAILDemonstrate 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 AUTHORINGSeamless integration between Vault and Microsoft Office Online provides real-time collaborative authoring and does so in a compliant way. See a demo.