Today enterprises of the life science industry and related lines of business such as the chemistry, cosmetics or food industry see themselves confronted with higher official requirements in regard to quality assurance and consumer or patient protection. Thus for example the manufacturing process - not only of medicine - is subject to both the tightened guidelines of the GMP (Good Manufacturing Practice) and the principles of GLP (Good Laboratory Practice) and GCP (Good Clinical Practice). Today these points are summarized under the primary concept of GxP. An important aspect of the listed guidelines is a proactive, comprehensive risk management. This emphasizes the beginning shift of both authorities and industry towards prevention oriented improvement of product quality and consumer protection.

With the obligation to traceability life science enterprises are required to supply a complete documentation and archiving of the respective documents and their contents while taking the stipulated workflow into account. Different national and international authorities such as the European Medicines Agency (EMEA) and the American Food and Drug Administration (FDA) order enterprises to present a detailed, complete and understandable documentation of their development and production processes starting with the product's introduction and continuing through the complete lifecycle of the product. The accuracy and transparency of the data including the changes carried out (change management) along the entire product lifecycle are of great importance for the observance of the regulations.

Companies from strictly regulated industries can rely on existing, comprehensive solutions based on COI-PharmaSuite for creating and managing of all GxP-relevant documents and contents. Aside from the pharmaceutical industry companies from areas such as biotechnology, cosmetics as well as the food industry also profit from our experience and long-standing know-how. This flows continuously into the further development of this solution. It assists companies in the observance of international standards, such as 21 CFR Part 11, EU GMP Vol. 3 and 4 Annex 11, ISO 9001 and the WHO. This process-oriented solution supports for example complete lifecycles and workflows, SOPs (Standard Operation Procedures), quality and management manuals as well as the officially demanded production documentation. Thus far-reaching chances arise for lasting competitive advantages.