Labeling challenges for the innovator
Innovator pharmaceutical companies generate numerous labeling documents spanning multiple therapeutic areas, across different geographies. The labeling process is quite complicated as it can require stakeholders around the world to pool the necessary information and documentation. Often even fairly simple chores like communication and tracking of documents tend to be a protracted and complex exercise. Considerable stress is placed on the system due to time critical activities like safety updates and the follow-on regional/local labels that need to be consistent with the CCDS and compliant with regulatory and language requirements across different geographies.
How does Managed Services solve these challenges?
Sciformix’s Managed Services provides a centralized and integrated ecosystem for creating new labels and labeling updates. It fosters organization-wide proactive collaboration, communication and management of the labeling process. On receiving a requirement for a new label or a communication for an update for an existing label, the manager of the process is able to communicate to all the stakeholders (internally and externally to the organization). Users can accumulate, share or distribute the source document (i.e. existing label, CCDS, IB, CO, etc.) to the stakeholders, allowing them to create, import and track information through a single interface. Our Managed Service platform can plug into existing legacy systems, allowing users to access and edit information, and track their actions through a single interface.
Structured, customizable process and workflow management
A safety update that has to be reflected in the global label and regional labels within a stipulated period of time can be actively managed and delivered through our Managed Service platform. It allows you to set timelines for critical activities and prioritize them against parallel projects. The countdown for the delivery day is shared with all the stakeholders to ensure focus, prioritization, synchronization and tracking.
Source data is accumulated through the customizable information capture template that acts as the common source of data for all stakeholders through the entire label cycle, thus minimizing downtime accessing and sharing data from multiple sources. It also enables tracking of documents and managing the edits or changes in label.
Standard templates, like QRD and PLR for the EU and US are built into the engine, allowing you to chose the default style and format to keep you compliant. The templates also allow you to auto populate information in the template, ensuring significant time saving and quality enhancements.
The QC module allows you to compare the template and highlight the difference in content, style and format. The engine’s two-way and three-way comparison tables and the auto generation of change logs play a vital role in documenting and ensuring compliance towards audit readiness. This reduces manual intervention by allowing quick review of labels by the labeling experts and quality personnel.
Unique request IDs are created to tag and manage other child requests and can be linked to dependent labels/countries. The engine detects and maps CDS changes to all applicable LPDs, as part of the same project file and allows you to manage non-English language LPDs as well through a reporting and analytics dashboard.