LABEL DEVELOPMENT
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.
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.
LPD Management
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.
https://www.freyrlabel.com/
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.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.
