Labeling

AUTOMATION SOLUTION FOR LIFE SCIENCES

See how Low-code, Workflow Automation and RPA can automate and streamline the labeling process.

The Labeling solution creates and manages label changes, addresses country-specific regulatory compliance requirements, and provides real-time visibility into the execution process. It augments your existing systems such as Veeva by leveraging the process orchestration, data integration and Low-code capabilities to streamline the labeling process from end-to-end.

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Business Drivers

Managing label changes is a core Life Sciences business process. Label changes require complex workflows to coordinate tasks and activities across a large team 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 changes to the local regulatory authority. The cost of error in not matching the regulatory requirements could result in heavy fines, product recalls and also compromise on patient safety.

Following are key business drivers for Labeling:

Global Spread: The Labeling request is created and approved at a global level and executed by teams spread across multiple countries.
Country Specific Workflows: Each country follows its own guidelines for submitting the label change.
Process Visibility: Real time transparency into the status progression across the countries.
Access to Documents: Availability of the right documents relating to the Labeling request.
Statutory SLA Compliance: Accurate monitoring and reporting of SLA compliance.

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Managing Label Changes

The Labeling solution from Princeton Blue augments your existing systems such as Veeva to automate the workflow and orchestrates collaboration for processing label changes swiftly. It leverages Low-code and BPM technologies 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.

How the Labeling Solution Works

Once a Label Change is initiated, the Labeling solution routes the change request for review and approval from headquarters and the impacted countries. The solution provides a comparison of the document associated with the current Label change request with the one associated with the previously approved label.

The solution integrates with the Artwork Management system to pull in the necessary artwork and provides a comparison of the new label vs the previously approved label. This provides the required visibility into the changes during approval.

Once the label change request has been approved it is released to impacted countries. The workflow splits into multiple paths – one each for the countries involved in the label change process. As the tasks are performed by the representatives of each country, the status is tracked at a global level for the label change request.

Unified Dashboard for Real-time Updates

The labeling solution enables business users to drill down into a specific label change request and see all the detailed information for that request. It provides visibility into how the request is progressing through the process, provide updates about the request from all countries involves and provide access to all the related documentation.