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Reg

Labelling

Traceable, generative, automated.

Manage the entire lifecycle of labels from CCDS through to labels and their translations, ongoing simultaneous variations, and artwork, including Change Requests and print shop sharing via the CARA Hub.

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

Step 1

Company Core Data Sheet (including building from data)

Step 2

Generate labels in MS Word, PDF, or Component-Based Authoring

Step 3

Generate translations and automate relationships and workflows

Step 4

Create and manage Artwork and Product Packaging

Step 5

Submit, track HA status, manage correspondence, registration

Step 6

Portal for Print Shops & Affiliates

Step 7

Trigger and manage Change Requests (HA Request, Safety Trigger etc.)

Step 8

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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