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.

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.

Request Management

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.

Change Management

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.

Freyr label 360 is a Pharmaceutical Labeling Software that Supports End to End Label Management, Label Tracking and Deviation Management for Pharmaceutical Companies across the Globe.