See how Low-code, BPM, Dynamic Case Management 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 leverages the process orchestration and Low-code capabilities combined Robotic Process Automation 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 leverages capabilities of the Low-code, BPM and RPA 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 triggered, the Labeling solution routes the change request for review and approval from headquarters and the impacted countries. The user enters initial information about the label change request, attaching any necessary documentation and provides required dates.

The Robot then compares the documents of the current Label change request with the one associated with the previously approved label. The Robot also pulls the latest Artwork for the drug from the Artwork Management system.

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.

Label mob
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Unified Dashboard for Real-time Updates

Drill down into a specific update request and see all the detailed information for that item. See how the request is progressing through the process, view details about the request including all the related documentation. View information that the robot was able to gather for parallel artwork requests.

Key Highlights

Combining Human and Digital Workforce

Applying Low-code automation to Labeling.

Collaboration between humans and robots automates the label change process and orchestrates tasks while providing real-time transparency into the status of a label change request at a global level.

  • Create simple workflows to handle multiple review and approvals (Low-code)
  • Routine and mundane tasks are handled by robots (RPA)
  • Exception handling and special approvals are escalated to human users (RPA)
  • Overall coordination between humans, robots and system tasks are handled by BPM (BPM)
  • Statutory SLA Compliance: Accurate monitoring and reporting of SLA compliance.
Labeling automation solution for Life Sciences

Business Impact

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