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.
LABEL TRACKING
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:
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.
Implementation Management
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.
ACCELERATORS
Some of the accelerators in Freyr LABEL 360 include its integration component which can be used for integration with Regulatory Information Management Systems (RIMS), MedDRA, and with Regulatory Intelligence systems and so on. The system maintains a repository of Label and Artwork Templates and Literature (such as: Illustrations, Journals, CT and other supporting data).
Label Comparison
In Freyr LABEL 360, labels can be compared in different ways and their key differences are highlighted clearly, such that global teams identify the labels which need to be updated. Labels of different regions can be compared with one another or they can be compared against the core label. The comparisons can be made based on the following criterion:
- Component-wise Dynamic Comparison: The components of a label can be filtered and compared with one another. The system enables comparison of different versions of the components; the differences are either strike through (to show deletions) or highlighted in a certain color to make the differences stand out.
- Text & Contextual Comparison: The system enables comparison between labels based on certain metadata or section(s) of the labels and based on their versions.
- Side-by-Side Comparison outputs for HA submission.
Integration with Regulatory Insights
Freyr LABEL 360 is integrated with Freyr IMPACT, an in-house Regulatory Intelligence tool. This integration enables the Intelligence tool to push the Regulatory updates related to product(s) or molecules(s) available in any of the labeling documents in Freyr LABEL 360. These updates are sent as notifications to the concerned line functions and enables them to acknowledge and further contemplate on the updates.
Repository to Store and Link Literature (Supporting Data)
Freyr LABEL 360 maintains a repository of all the supporting documents, clinical overviews, non-clinical data, journals, illustrations, etc. These documents can either be uploaded while creating a label or directly into the repository. The literature is linked to the metadata in the label documents and it can be linked to other documents, too. The system also maintains a repository of generic labels (both CCDS and LPDs) and product labels.
REPORTS
Freyr LABEL 360 can produce pre-defined static reports. It can also generate dynamic reports, as and when required.
Compliance Reports for HA Submission
The system provides detailed compliance reports based on product(s), region(s), and priorities highlighting the count of each report type (compliant or compliant with a condition); it represents the data in the form of graphs and statistics. All these reports can be exported at any given point in time.
Static and Dynamic Report Generation
The system provides some reports on the ‘Impact Assessments’, ‘Deviations’, and ‘Global/Local Initiated changes. Dynamic reports can also be generated in the system to provide the real-time data.
VALUE ADDITIONS
Below provided are some of the key features in the system, which makes the labeling process in the respective modules simpler and streamlined.
Impact Assessments (Global and Local Impact Assessments)
Both global and local impact assessments can be performed individually. Non-safety changes at a local level can also be subjected for global impact assessment. The system identifies and notifies the impacted countries as soon as the impact assessment is performed.
For the downstream processes like LPD, Artwork, Printing and Supply chain, the impact assessment can be performed individually. Furthermore, product registrations of countries can be grouped/bundled, and their impact can be assessed together.Deviation Management
Freyr LABEL 360 has a looping mechanism for maintaining and tracking the deviations. The variations ‘rejected’ or ‘partially accepted’ by the regional teams are routed to the global teams for further repercussions. This back and forth communication between the teams is maintained with transparency. Not just the dates, the system also maintains a record of the rationale provided by the regional affiliates for rejecting or partially accepting a given change.
The agreed deviations can be grouped and implemented together in the system. The system can also accommodate partial implementation of grouped changes such that few are implemented immediately and the others in the subsequent cycle. The system categorizes the deviations as ‘Action Immediately’ and ‘Action Later’, which makes it easier for the users to identify and plan the pending deviations. The system does not allow the users to proceed with the new deviations, unless the pending deviations are readdressed.
Content to Carton Traceability
In Freyr LABEL 360, product registrations are linked to pack sets, pack sets to components and the components are in turn linked to finished products. This link is established to provide traceability of the product at all locations, right after its dispatch from the warehouse and distribution to destination countries, until they reach the shelves in the pharmacy stores. With this level of traceability, it is also possible to trace a supply chain item back to the product, which is further linked to the product request created in the system.