Document management systems as basis for the electronic submission of dossiers for the marketing authorisation process

The Regulatory Affairs department depends enormously on the timely delivery of the required documentation by the Research and Development departments. The documents have to be prepared in the correct format and structure if time-consuming editing and reformatting procedures are to be avoided before the documents can be integrated into electronic dossiers. Electronic submission may well speed up communication between the applicant and the authorities, but the main potential benefit of electronic document management is to the company itself, by speeding up the preparation and unproving the quality of documents for submission. If electronic submission is not seen merely as a question of providing an interface between Regulatory Affairs and the authorities but rather as the logical consequence of installing an electronic data and document management system within the entire company, then the scope of development and implementation can be designed accordingly. Only e-submission in combination with an interdepartmental document management system within the company can effectively speed up the preparation and improve the quality of documentation. Electronic document management revolutionises work processes by promoting the standardisation of content, format and structure of documents. Responsibilities have to be redefined. Whole process steps either become redundant or are fully automated. For the development and introduction of a DMS, the basic framework and a multitude of details have to be considered. The following guideline aims to provide support to enable a DMS project to be successfully carried out in a pharmaceutical company.