Module 12 2019

Publish & Release for Submission

Create & Review for Submission

1. I can easily identify the product, the procedure and the PI I am working on 2. I can upload my PI in any file format into the Creation Tool 3. I can edit my uploaded PI directly in the Creation Tool if needed 4. The Creation Tool converts my PI (e.g. Word, ePI schema) into any format (e.g. xml, pdf) that is requested by the authorities 5. The Creation Tool recognizes and maintains applied formatting (italics, bold, etc) and transcribes it into the ePI schema 6. The Creation Tool automatically splits the content into QRD relevant sections taking into account existing formatting and the granularity of the ePI schema 7. The Creation Tool automatically converts tabulated information presented in e.g. Word or PDF into the ePI schema 8. The Creation Tool supports automated translations of the fragments generated for the ePI schema 9. The Creation Tool makes use of available and validated SPOR information (intelligent assistance) 10. The Creation Tool allows for version control and tracking of the version history 11. The Creation Tool allows for comparing the previous version of a fragment with the current one and can display changes in content (track change mode) and even across my products (i.e. in case of an alternative strength) 12. The Creation Tool can correctly identify symbols whether they are Unicode or not 13. The Creation Tool can correctly place pictograms/pictures as per the originator document 14. The Creation Tool allows for interim storage of ePI with the capability to follow up on previous tasks later on 15. The Creation Tool allows for adding attributes/metadata such as approval date, procedural details, etc 16. The Creation Tool follows the WYSIWYG principle and can provide a final document preview page 17. Because I am working on fragmented information I can re-use the information across my products 18. Editing several documents in one step with common text 19. Preselection options : excipient list; pre-defined text; 20. Pre-written ‘help’ text for support (tool tips) 21. The creation tool allows editing of several related documents (different strengths) with common details 22. Tool capability to track multiple fragment updates in parallel /generate a section mapping 23. Creation tool has access to the use of a dictionary when providing various sections in different languages 24. The creation tool supports automatic fragmentation of text on upload of any document type. 25. The Creation tool allows creation of fragments beyond QRD sections to support reuse of common text. 26. The Creation Tool allows one MAH to act on behalf of another MAH in order to maintain one common text for specified products 27. The creation tool automatically prefills relevant sections with data from single source for confirmation and check by MAH (e.g. OMS data) 28. The creation tool allows preparation of duplicate texts with a simple ‘copy’ action and automatically adapts relevant fields (e.g. tradename) based on master data. 29. The creation tool can recognise and provide ‘tag’ suggestions for key text such as ‘Unit’ ‘dose’ ‘indication’ to support later downstream use of the data. 30. The creation tool allows comparison to previous major or minor versions and export of such ‘annotated and tracked change’ for internal company use during submission preparation 31. The creation tool support the auto-population of ‘present and proposed’ sections of application forms 32. The creation tool includes real time hints to users e.g. automatic proposals for inclusion of information as attributes and replacement with placeholder information 33. The creation tool supports author assistance to provide suggestions of similar fragments available in other products to allow identification of re-used text in a simple and efficient way 34. The creation tool provides a ‘here used’ functionality to support identification of re-used fragmets. 35. The creation tool provides hints ‘do you also want to update..’ products where fragments have been re-used. • • •

The Creation Tool allows for version control and tracking of the version history The Creation Tool allows for reverting back to the final completed document for reviewing i.e. pdf <-> xml exchange The creation tool should master the same application for text conversion into ePI, CTD document management and eCTD publishing. (Export via standard, rest depends on software vendors and cannot delivered by the Creation Tool) Tool capability to track multiple fragment updates in parallel /generate a section mapping

•

The Organisation for Professionals in Regulatory Affairs