What is a publishing engine?
A publishing engine is software that automatically generates a dossier from a set of individual electronic files. In the case of a typical paper-based CTD, the publishing engine divides the submission into appropriately sized volumes, adds page numbers, headers and footers if required, resolves cross-references and inserts tables of contents and cover sheets at the beginning of each volume. The output is a typically a collection of PDF files, one for each volume, that can be printed, copied and assembled in the usual way. In the case of an eCTD, the publishing engine creates the eCTD directory structure and populates it with PDF files, resolves hyperlinks, calculates MD-5 checksums and creates the XML backbone automatically. The output is a complete eCTD which can be copied to a CD-ROM. Integrated document management and publishing solutions for CTDs and eCTDs are available commercially from numerous vendors (see our vendor links page).
