In Life Sciences arena, global health authorities always guide and mandate the manufacturers to demonstrate the safety and efficacy of a product through compliant labeling procedures. It is because the labels act as key channels of communication between the product and the end user. Companies must ensure compliance in communicating its safety data right from Core Data Sheet (CDS) to Local Prescribing Information. At the same time, companies are obliged to track and implement the labeling changes and local variations in real-time. Failure to respond quickly to changing product information or market requirements can result in non-compliance issues and rejected product registrations, which may affect the revenues overall.
Given the dynamic nature of Regulatory scenarios, and manufacturer’s wide market presence and product portfolios, it is challenging to keep track of global changes and to ensure their accurate implementation in real-time. Hence, they are in dire need of a single stop labeling solution that takes control of the end-to-end labeling process right from content to carton. But what should they consider while choosing such a labeling platform? Ideally, the tool should address the below-mentioned key features:
- Label Management
- Tracking and Traceability
- Commercial Implementation
A product with a wide geographical footprint would require labels in each region/country to comply with specific regional Regulatory requirements. However, for most companies, the primary processes involved in developing such labels are prone to procedural lags and gaps as multiple stakeholders are involved in the labeling process. That increases the complexity in label management and therefore increases the labeling cost.
Hence, a holistic, transparent, cost-effective, and globally connected label management system, which integrates processes across the product lifecycle, is necessary.
Tracking and Traceability
In a product’s lifecycle, depending on the regional or global requirements, a label change can be triggered. It may, in fact, affect some or all the components of a label. In such a scenario, label status tracking by manually integrated processes or through legacy systems might be insufficient to keep track of the change for impeccable implementation.
Hence, a labeling tool, which provides end-to-end traceability of information from ‘content’ to ‘carton’ is necessary. Such a labeling tool enables real-time intelligence on global label changes and their implementation all through the upstream and downstream labeling processes.
Once a label change is tracked, the proposed change must be implemented across upstream labeling processes (like CDS) and across the downstream processes (like LPD, Artwork, Printing, Supply Chain, etc.).
For this to happen, manufacturers require a system to realize the content changes in real-time and ensure they are implemented without a fail. The system should maintain a linkage between product registrations to artwork components to supply chain items.
With those features decoded, we are certain that you would like to find one such single-stop labeling solution that can track, manage, validate and implement all the global label changes in real-time. Be game for the reality check with our one-stop labeling solution – Freyr LABEL 360. Request a demo.