Sections in this article
- About Vault SafetyDocs
- Controlled Access
- Version Control
- Content Binders
- Automated PSMF Logbook Entry Generation
- Electronic Signature and Manifestation
- Comprehensive Audit Trail
- Real-time Collaborative Authoring
- Document Taxonomy
- Configurable Workflows
- Validation Ready
About 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.
Vault SafetyDocs enables internal and external users to securely access safety documents on any device from a major web browser. Users can only see and perform tasks based on their assigned security role.
Automated versioning and document version comparisons make it easy to see how the content has changed while maintaining a full audit trail.
You can quickly organize and manage complex documents, such as pharmacovigilance system master files (PSMF), with binders. You can link to source documents in the safety, quality, regulatory, clinical, or other Vaults in the same domain to ensure a single source of truth for safety related content.
Automated PSMF Logbook Entry Generation
When merging to a PSMF PDF, a logbook is automatically generated for each major version of a PSMF Document. This tracks the following details:
- The document name
- The date of the changes
- The person who made the changes
- The document version number
- A summary of the changes
Electronic Signature and Manifestation
Users can approve documents using electronic signatures and manifestations that are compliant with Title 21 CFR Part 11 and Annex 11.
Comprehensive Audit Trail
Your company can 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, including aggregate report authoring.
Note Vault SafetyDocs does not include automated table generation for aggregate reports. You must have a full Vault Safety license to generate aggregate report tables.
You can easily establish a document taxonomy and standard picklists for safety documentation to facilitate harmonization and collaboration of safety information across quality, regulatory, clinical, and other departments or organizations.
You can automatically route content for review and approval to align with business processes with the ability to schedule tasks based upon document expiration or periodic reporting intervals.
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).
Vault Online Help provides information on Vault document authoring, collaboration, and management.