Labeling

Overview

Label changes require complex workflows to coordinate tasks and activities across a large team that’s spread out globally. Once a Label Change is reviewed and approved at the global level, each country follows its own guidelines for submitting the label change to the local regulatory authority. The ability to automate these tasks while providing real-time transparency into the status of a label change along with access to the right documents at a global level is a key requirement for automating label changes. The Labeling process is also governed by stringent regulatory SLAs.

Pain points to traditional approach of Labeling include:

• Rigid workflows
• Complex global workflow involving multiple approvals from impacted countries
• Limited visibility into the process such as status of activities across countries
• Disparate and siloed systems
• Documentation relating of a label change request resides in silos of multiple applications

Key Features & Functionality

The Labeling solution from Princeton Blue augments your existing systems such as Veeva, to automate the workflow and orchestrate collaboration for processing label changes swiftly. It leverages the Appian platform to create a controlled label change process. With multiple reviews, it ensures quality and adherence to regulatory standards. The solution automates the entire workflow and orchestrates collaboration required from various stakeholders to process a label change.

Benefits & Business Impact

• Configurable Approval Workflows
  • Label change approval levels based on fully configurable business rules enables your organization to quickly respond to the changing business conditions
• End-to-end Automation
  • Complete automation of label change request submission, review and approval process enables multiple reviews and approvals to ensure the time-to-market for any drug is low.
• Transparency
  • End-to-end visibility provides a complete audit trail of the entire labeling process allowing for any modification or change.
• Interactive Dashboards
  • With visibility into process execution via interactive dashboards and reports, your organization can pick up early signs of process friction and bottlenecks for continuous improvement of the label change process.
    

2018 AppMarket Award Winner in “App Innovation in Business Operations”