Labeling
AUTOMATION SOLUTION FOR LIFE SCIENCES
Automate the global label change workflow to improve process transparency and accountability.
The Labeling solution creates and manages label changes, addresses country-specific regulatory compliance requirements, and provides real-time visibility into the implementation process. It augments your existing systems such as Veeva by leveraging the process orchestration, data integration and Low-code capabilities to streamline the label change management from end-to-end.
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Business Drivers
Managing label changes is a strategic business process for pharmaceutical companies. 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. Lack of compliance with the regulatory guidelines can result in heavy fines, product recalls and compromise patient safety.
Following are key business drivers for Labeling:
- Global Spread: Management of label change requests that are created and approved at a global level and implemented by teams spread across multiple countries.
- Country Specific Workflows: Each country follows its own guidelines for submitting the label change that needs to be incorporated into the process.
- Dependency management: Managing the impact of an approved label version on other in-flight label changes.
- Process Visibility: Real-time transparency into the status progression across the countries including all versions of label changes.
- 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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Automating the Label Change Workflow
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 to create a controlled and fully auditable 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 label changes globally.
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 label change request with the latest approved label.
The solution integrates with your 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 the review and approval portion of the process.
Once the label change request has been approved, it is released to the impacted countries. The workflow splits into multiple paths – one each for the countries impacted by the label change. As the tasks are performed by the representatives of each country, the status is tracked at a global level for each label change request.
When a label version is approved by the local health authority for a specific country, the label change requestor at headquarters is automatically notified about the approval, so the new label can become the basis for future label changes.
Key Features of the Solution
Process Orchestration
Process Visibility
Configurable Workflows
Exception Management
Unified Data View
Document Comparison and Management
Rapid Customization