DirectusPRO
A unique label management, tracking, and reporting solution.
The only comprehensive global labeling system that addresses the market gap in providing a system that can effectively and efficiently enable a global end-to-end labeling process.
Drive Operational Excellence
Ensuring efficient information flow from source label (CCDS or other) to local labels and across all local labels
Stay Compliant
Ensuring consistent scientific, medical, and administrative information across all labels globally
Streamline Tracking and Reporting
Ensuring traceability of historic changes globally at the content level (not only at the document level)
Safety Signal Log
DCDS & CCSD Management
RPI Management
Tracking
Proof Reading
Comparison
User Management
Documents Library
Inbox
Label Comparison & Alignment
The ability to compare labels and manage content from version to version or label to label
Management of Simultaneous Labels in Review
The ability to track and manage simultaneous label updates, ensuring compliance with the latest approved version
Track & Monitor Label Compliance
The ability to track and monitor label compliance from source label to local labels
Features
CORE FUNCTIONALITY
- Structured content and component based authoring
- MS Word-like document editor with an XML-like backbone
- SPL conversion
- Structured document templates
- Redlined and annotated label management
- Label history and health authority correspondence management
- Management of label summary of changes and label dissemination
- Document content indexing and search
- Automated naming and versioning convention (no manual entries)
- Configurable workflows
- Searchable document repository
- Single-view/click document associations
- Intuitive user interface and experience
- Notifications within system and to external emails
- Visual cues and reminders
INFORMATION MANAGEMENT
- Core data sheet
- Regional product information
- Drug listing
- Labeler code
- Establishment
- Translations
TRACKING AND REPORTING
- Core data sheet dissemination and actions
- Regional product information dissemination and actions
- Regional product information health authority submissions and
interactions - Compliance of label to both source label and to supporting
information - Workflow status (including internal and health authority
approvals) - Simultaneous variations and versioning
TECHNICAL CONSIDERATIONS
- Robust configurable access and permissions
- Validated
- Client audited
- API-enabled integrations (SSO and other systems)
- Dedicated virtual private cloud
- Complete data isolation for tenants
- 21 CFR Part 11 compliance
- Audit trail
- Encrypted data at rest and in-transit