
Labelling
Traceable, generative, automated.

Labelling on the CARA Life Sciences Platform simplifies your processes and automates the traditionally complex challenges.
Challenges Managed:
Working with all types of documents: from 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 Directories
Company Core Data Sheet (including building from data)
Generate labels in MS Word, PDF, or Component-Based Authoring
Generate translations and automate relationships and workflows
Create and manage Artwork and Product Packaging
Submit, track HA status, manage correspondence, registration
Portal for Print Shops & Affiliates
Trigger and manage Change Requests (HA Request, Safety Trigger etc.)
Update components based on 'where used' tracking

Authoring
Create template components or documents
Build a complete document from 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
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

Benefits
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.
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