End to End Labelling Management from Core Data Sheet, through authoring, translations, artwork and change management to registration.
Labelling made simple
Managing Labelling documentation is a complex matter for Life Sciences companies, given not only the variety of the documents (Core Data Sheets through to individual labels for different dosage forms, strengths and markets), but also the need for managing translations, regulatory affairs interactions internally and with authorities, the changing industry regulations for such content, and the need to interact with Product Supply and integrate feedback loops from new safety / efficacy data and regulatory directives. CARA allows this complexity to be handled in a secure and simple way.
- Create your content inside Documentum using CARA – fully configurable next generation UI
- Author in small components (paragraphs, sentences) and build a complete document from the these
- Reuse components across documents (from Core Data Sheet to Labels, PI etc)
- Integrate labelling documents into submissions
- 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
- 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
Submit, track, update
- Update information in CARA on Health Authority approval status – seamless integration with registration tracking
- Understand how an update required on one piece of labelling information has to flow to other label documents for other dosages, markets and translations
- CARA Dashboards allow reporting across documents, products and markets