INFORMATION CREATION AND MANAGEMENT SYSTEM

摘要

Information about chemicals (or groups thereof) can be tracked during the drug discovery, approval, and maintenance processes. Such a system reduces the amount of data entry required compared to systems that require re-entry of data from an earlier phase to perform tasks in a later phase. The system further provides (i) a standardized way of recording information, (ii) a secure and accessible environment for storing and managing the information, and (iii) a system for compiling the information into a variety of regulatory dossiers and other documents by re-using the information. By re-using components (e.g., modules), documents can be used as a starting point for the creation of new documents. The previously approved sub-documents or modules can be managed according to a life cycle. Use of the life cycle reduces the chance that a document with errors will be released.