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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.

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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)

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Safety Signal Log
DCDS & CCSD Management
RPI Management
Tracking
Proof Reading
Comparison
User Management
Documents Library
Inbox
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Label Comparison & Alignment

The ability to compare labels and manage content from version to version or label to label

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Management of Simultaneous Labels in Review

The ability to track and manage simultaneous label updates, ensuring compliance with the latest approved version

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Track & Monitor Label Compliance

The ability to track and monitor label compliance from source label to local labels

Features

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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

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INFORMATION MANAGEMENT

  • Core data sheet
  • Regional product information
  • Drug listing
  • Labeler code
  • Establishment
  • Translations

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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
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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

Let's start the conversation

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