Development and Production of the Electronic Virtual Pharmaceutical Dossier

This dissertation proposes the implementation of a new electronic document management system (EDMS) to assist a United States pharmaceutical company in the filing of an electronic or virtual drug submission to the Food and Drug Administration (FDA). The goal of this EDMS was to reengineer the process of producing pharmaceutical submissions by creating a digital document repository providing a single point of reference and control for all document versions, thereby decreasing the cycle time of business-critical documents circulating among departments and between the company and the FDA. Another objective was to clarify the document standards that form the basis for the compound document management architecture of this emerging technology (ET) by incorporating object oriented technology. The project management approach was used to define requirements, maintain funding continuity and evaluate progress. A project manager served as the integrative force throughout the project, and he selected a project team composed of people from the path of critical document production. The project team selected the EDMS that met all the technical requirements, price and an intuitive and user-friendly graphical user interface (GUI). A pilot project using a discrete set of documents tested this ET. The success of this project was judged on testing the usability and effectiveness of the GUI of the EDMS in 16 participants and shortening the cycle time of business critical documents within the company. Critical success factors included the availability of immediate benefits such as the direct access to different file formats from a common digital document repository offering version control and an audit trail of documents via workflow, the ability to search the company\u27s knowledge base, improved internal communication, and the reusability of information by all process members. Test results and post implementation feedback from users demonstrated that the EDMS pilot project was the path to the electronic submission. A quicker time to market of pharmaceutical products plus a greater market share for the company are the anticipated longer-term business deliverables of this ET. The major innovation is that knowledge workers will now have the means to create an electronic submission by processing the documents electronically instead of manipulating physical documents