Medical product document production

摘要

A method of producing a document for regulatory approval of a medical product, comprising entering data objects pertaining to a study of the medical product into a database, providing a document format defining delimited data fields for insertion of data objects, providing a user interface for selection of the data objects to be included in the document, extracting data objects pertaining to the study from the database, using the extracted data objects as defined by the document format to generate the document compatible with a document publishing system, and publishing the generated document. The invention also relates to an apparatus for computer-aided composition and generation of a medical product document.