Labelling
End-to-End Labelling Management
Labelling
Learn more about managing the RIM process on the Platform
Learn more about managing the RIM process on the Platform
Labelling on the CARA Life Sciences Platform simplifies your processes and automates the traditionally complex challenges.
Challenges Managed:
Working with all types of documents - Core Data Sheets to Individual Labels
Automating Translation Process
Regulatory Affairs Interactions (Internally and with Health Authorities)
Changing Industry Regulations
Interacting with Product Supply
Integrating Feedback Loops from New Safety / Efficacy Data & Regulatory Directives
HOVER
Company Core Data Sheet (including building from data)
Update components based on 'where used' tracking
Generate labels in MS Word, PDF, or Component-Based Authoring
Trigger and manage Change Requests (HA Request, Safety Trigger etc.)
Learn about managing correspondence in our RIM solution
Correspondence & Commitments
RIM
Generate translations and automate relationships and workflows
Portal for Print Shops & Affiliates
Submit, track HA status, manage correspondence, registration
Create and manage Artwork and Product Packaging
Authoring
• Create template components or documents
• Build a complete document from the these components
• Reuse components across documents (from Core Data Sheet to Labels, PI etc)
• Compare labels (e.g. master label and derived label)
• Reconcile local market changes back to the master label
• Build labelling documents using data from other disciplines e.g. Clinical, ensuring that updates in the source data flags the requirement to update labelling documentation
Submission
• Use the labels directly in the CARA Regulatory Submission documents
• Easily track which versions of which components or compiled labelling documents were submitted where, when, and whether a regulatory change request must be reflected in other markets
• Push labelling information through to Product Supply and artwork production
• Output files in format required by different regulatory authorities including SPL
Learn about submission documents on the CARA Life Sciences Platform
Learn about submission documents on the CARA Life Sciences Platform
Use & Maintenance
• Push labelling information through to product supply and artwork production
• Create change requests using the CARA QMS to manage ongoing changes
• Manage production options (continue using existing packaging, destroy all packaging etc)
• Automate translations
Structured Content Authoring
Author individual components that are collated into single labels
Submission & Product Integration
Seamlessly integrate the labelling documents with both labelling production systems and submission systems
Where Used
Easily track and trace where each version of each label has been submitted and approved during which date period
Reconcile Multiple Labels
As labels are changed in local markets, identify changes and reconcile back to master labels
Translations
Manage translations of labels including providing a portal access via CARA to translation companies
