Herzogenaurach 03 September 2008 – The pharmaceutical company Octapharma GmbH from Langenfeld (Rhineland) will employ COI-PharmaSuite for both the preparation of drug dossiers and the publishing of drug certification documentsr the archive, document (DMS), and workflow management system (WMS) COI-BusinessFlow of the software developer COI GmbH from Herzogenaurach.

Before choosing a specialized software to support the drug certification processes, the company took a very close look at the various providers from this sector. In the end, COI-PharmaSuite was able to satisfy all requirements and the innovative solution by COI GmbH was chosen.

COI-PharmaSuite is based on the integrated archive, document, and workflow management system COI-BusinessFlow 4X, in which all streams of information merge across processes and departments. The solution supports the staff in various way, such as in the preparing of new documents, managing of document versions and follow-ups. Access to specific documents can be managed by authorization structures.

For drug admittance, COI-PharmaSuite is employed along with its modules Regulatory Affairs and eCTD Export. The module Regulatory Affairs supports the entire administrative core process of drug admittance in accordance with the official requirements. For instance, as soon as documents relevant for certification are prepared, they are recorded in the system where they are administered and made available for the preparation of dossiers. Predefined document sets and structure envelopes (e.g., the Common Technical Document format, CTD) simplify dossier preparation while clearance and control mechanisms with specific access authorizations provide higher quality and better security. This is complemented by extensive search functions for dossiers, dossier chapters, drugs, components, scientific papers and catalogs. The dossiers are created according to the predefined CTD structure and thus comply with the EMEA requirements (EMEA: European Medicines Agency). The system covers all stages of the certification dossier's life cycle – from creation to approval to market exit.

The related module eCTD Export transfers information to the data system for electronic publishing of drug dossiers, or parts thereof. This is done using the eCTD formats stipulated by the ICH (International Conference on Harmonisation).

Dr. Bettina Gerlach, head of Regulatory Affairs at Octapharma Langenfeld on the purchase of COI-PharmaSuite incenses:

"The concept of an integrated system – having an archive and a document management system alongside the actual certification software – is the most consequential of all those evaluated and thus convinces in both theory and practice. Regulatory Affairs are a highly complex process characterized by countless laws and guidelines. As the number of national and international regulations is growing continuously, the help of such an ingenious software ensures a quick and orderly submission and is therefore an investment in the future."

Information on Octapharma
Since its founding in 1983, Octapharma has been specialized in the development, production, and sale of plasma derivatives. Core business includes ultrapure, virus-inactivated drugs for use in immunology (antibody deficiencies), hemophilia (bleeding disorder), and intensive care (coagulation disorder). The aim of Octapharma is to develop top-quality products by innovations and use of latest technologies as well as to continuously improve the handling of existing products. In this respect, Octapharma is the first company in the world to introduced the solvent/detergent method (S/D) for virus inactivation on an industrial scale. This is a milestone in the making of virus-inactived plasma products.
At the moment, some 2,000 employees of the pharmaceutical company in more than 50 countries ensure that the high-quality products comply with current clinical and regulatory requirements. Four up-to-date fractionation plants in Springe (Germany), Vienna (Austria), Lingolsheim (France), and Stockholm (Sweden) guarantee a worldwide supply for patients while optimally utilizing the valuable plasma.