Pharmaceutical Labeling Software, Regulatory Labeling Management
The entire workflow of the labeling documents can be managed effectively in Freyr LABEL 360. The system has options for authoring at ‘Document Level’ and ‘Component Level’; each having its own significance and ease in label development. Labels can be created, enhanced, versioned and their progress can be tracked, right from the initial stages to the time when they’re finalized and distributed to the impacted countries. The users can either choose Document Level Authoring or Component Level Authoring to develop their labels availing Freyr LABEL 360.
Document Level Authoring
Core Label Documents and Regional Label Documents can be created and managed within the system. They can be linked to the requests created in the system or they can be created and managed independently. The system has secure plug-ins to enable authoring with ‘MS Word’ like features. The system maintains a workflow between the ‘Draft’ stage of a document and it’s ‘Review-Approval’ cycle and notifies all the line functions on the progress of the document. All changes made to the documents are saved in the ‘track change’ mode. Versions of the document can be created for each review, approval or rejection cycle. Supporting documents like illustrations and journals can be uploaded and linked to the documents, which can be associated with documents created in future.
Document Level Authoring
Component Level Authoring
The labeling documents can be split based on their product components. While authoring, each component can be ‘checked-into’ by individual users, which is as good as ‘locking’ the component. The authors can flag and mark each component once the content is ready for review. The entire document can be pushed for the review-approval cycle when all the components are ready for review. Documents can be up-versioned at any given point in time. The system provides ‘version’ wise comparison and it highlights the changes between the document versions. Literature (such as supporting documents, illustrations, journals) can be uploaded and saved for each component of the document; they can be linked to other documents, too.
Document components and subcomponents can be re-arranged, and additional ones can be added at any point, throughout the document workflow and progress. With Component Level Authoring, ‘dynamic’ label comparisons of different components can be done, at any given point in time.
Core Label Management
All core labels like CCDS/CCPI can be collaboratively developed, reviewed and authored in the system by different users. Each document can be linked to ‘Active Ingredients’ and ‘Products’. If the ‘Label Tracking’ and ‘Label Management’ modules in the system are integrated, the change requests created in the system can also be linked to the core label documents. With this integration, tracking dates of the document are generated based on the progress of the document within label management. The system can also be integrated with other document management systems, if required.
Apart from authoring and review-approval of core documents, the system identifies the impacted countries and distributes the core documents to the concerned stakeholders. This distribution is done through the system by sending email notifications to the country affiliates; the system also maintains a record of the list of countries.
All regional level documents, ‘Patient Information’ (PI), ‘Patient Information Leaflets’ (PIL), and ‘Medical Guides’ can be created and managed in the system. The documents can be linked to products, active ingredients, and the change requests associated with them, within the system. The system follows a streamlined workflow to push the documents from the draft stage to the review-approval cycle. Different versions of the documents can be created at each Review-approval/Review-Rejection cycle.
Freyr LABEL 360 has a process integrated tracking module which enables receipt and triage of the proposed variations and tracks their implementation all through the upstream and downstream labeling processes. From performing impact assessments (global and local) to tracking the changes at each functional level, the tool provides end-to-end traceability of information from label ‘content’ to ‘carton’. It is specialized in:
Freyr LABEL 360 enables triage of the incoming requests, for both global and regional labels. Variation requests for ‘Core’, ‘LPDs’, ‘Artwork’, ‘Printing’ and ‘Supply Chain’ can be created and tracked separately in the system. Requests can be prioritized based on their categories, which in turn triggers relevant SLAs and notifications are sent to the cross-functional teams of the impacted countries to ensure timely action on the requests.
Freyr LABEL 360 provides a platform where variations can be proposed, created and tracked until implemented in the core labels. Changes proposed for upstream labeling processes like ‘Core’ are extended sequentially to the downstream processes at each level (such as: LPD, Artwork, Printing and Supply Chain). The system can also identify the countries impacted by the proposed changes and notifies the concerned stakeholders about the change, well before the CCDS distribution. Timely notifications and reminders are sent to the end users based on whether the requests are put on hold or are to be implemented and tracked, or if they are terminated.
With Freyr LABEL 360, ‘Distribution’ of proposed changes can be done seamlessly as it can be integrated with Regulatory Information Management Systems. This makes it easier to identify the countries and the registrations, impacted by the change.
Freyr LABEL 360 is a process integrated tracking tool, which follows the best industry practices. Changes can be tracked at all functional levels (regional labels, artwork, printing and supply chain). The system lets the functional teams decide if the requests are to be submitted to the health authorities or just to notify. Based on these decisions, the system further calculates the SLAs and tracks the action taken at each functional level. In case of Regulatory or procedural dependencies, the system calculates the SLAs of dependent countries based on the predefined SLAs of the lead countries. Furthermore, the system also maintains a record of dates related to individual artwork and supply chain components.
The system ensures the implementation of content changes from product labels to cartons, by maintaining a link between the product registrations, its packets, artwork components and supply chain items.