Method for managing a business process related to a document publishing project

#Document publishing projects, such as those involved with the production of new drug/biological product marketing authorization applications (such as Investigational New Drug documentation (“IND”) and New Drug Applications (“NDA”)) for submission to the Food and Drug Administration (“FDA”) or corresponding regulatory bodies in, for example, Europe and Japan, are time consuming and labor intensive. These projects typically involve organizing and processing enormous amounts of documents and data. Such documents and data require specialized handling, as they are typically received in both paper and electronic form, and are in various file formats. In addition, given the large size of these projects, many worker resources are required over long periods of time are necessary to complete them. Issues virtually always arise, either with respect to processing the documents themselves, or with respect to worker resources or timing of projects. For these and other reasons, managing the document publishing process presents many challenges.

#The present invention relates generally to methods for managing business processes relating to document publishing projects.

#The present invention is directed to a method for managing a document publishing project. Document publishing project information is received. Upon receipt of the information, a plurality of work flows based on the information is automatically identified. Each work flow comprises one or more tasks and each task is associated with a capability for completing the task. A worker resource who has the capability associated with the task is automatically identified for each task. A schedule for the project comprising a task sequence and a resource allocation is created.

#The accompanying drawings, which are included to provide further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

#In the drawings:

#FIG. 1A illustrates an exemplary system for carrying out a preferred embodiment of the methods of the present invention.

#Reference will now be made in detail to the preferred embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

#The present invention provides a flexible method for managing projects relating to the production of large publications. The invention is particularly well-suited for managing the production of new drug/biological product marketing authorization applications (such as INDs and NDAs). However, the inventive system and method are equally suitable for managing the process of producing any high content volume publication. The inventive system and method can be used in connection with a project involving a single publication, or a portion thereof, or multiple publications. Publications (also referred to as submissions if submitted to, e.g., a regulatory authority for review), such as NDAs or INDs, typically are comprised of various types of content items that are arranged in accordance with a defined, hierarchical structure. For NDAs and INDs, this structure is specified by the agency that will review the application (i.e., in the United States, the FDA). Currently, publications of this sort are preferably submitted electronically, rather than in paper form given the extremely large volume of paper involved. The present invention can be used in connection with both paper and electronic submissions.

#With reference to FIG. 1A, a system for implementing the present invention is illustrated. The document publishing process may involve a number of actors, each with different roles in the process. For example, upon the receipt of information relating to a document publishing project, a first actor(s) using client 10 may identify the information, determine what steps are required for processing the information, and work to implement schedules for completing the processing. Next, a number of second actors (e.g., worker resources), each using a client 5, are involved with the actual processing of the information. Finally, a third actor(s), using client 15, manages and plans multiple document publishing projects. Each of clients 5, 10, and 15 are networked to server 16, which includes a processor as well as one or more databases 17 for storing data used in connection with implementing the inventive methods. An exemplary data model for database(s) 17 is illustrated in FIGS. 1B through 1E and is described in more detail at various points within this detailed description of the invention.