Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory electronic Document Management System (eDMS) in the pharmaceutical industry

Florentina Zymberi (Abschlußjahr: 2013)

Summary
Language: English
The pharmaceutical industry is a subject of a complex regulatory framework of laws, regulations and guidelines, which requires a professional and skilled handling of document collections and management of R&D information globally. Today the pharmaceutical companies are under pressure to accelerate the time market for their drug products, to improve their product line and to adherence strictly to quality and regulatory requirements. Many regulations such as FDA rule 21 CRF Part 11, EU Annex 11 and GxP guidelines as well as the new submission requirements concerning electronic submission create in their implementation and in particular in compliance with regulatory requirements a challenge to the pharmaceutical companies and organizations. The big challenge today for pharmaceutical companies is to identify early the emerging regulatory and technology changes, to understand the IT systems and rules correctly and interpret them in order to proper manage the huge volumes of data, to avoid regulatory risks and finally to meet the global regulatory requirements. Nevertheless, the approval process of bringing new drugs to pharmaceutical market must be always stringently transparent, efficient and well documented. Without an accurate electronic document management system can be difficult to achieve transparently and efficiently in the complexes R&D process. If we look today at the pharmaceutical market and compare with the developments in recent years, we can realize, that the pharmaceutical regulatory standards, IT-technologies and requirements for electronic document system have changed rapidly and positively in last years. For understanding such of rapidly changes and the current regulatory standards according EDMS first of all we have to understand the terminology, the technology, regulatory standards and the processes involved.
Some of already established IT- and pharmaceutical regulations and compliance tools and solutions enable the easy practical implementation of standards and regulations in relation to EDMS.
By using the adequate EDMS solution platform that is specified for the pharmaceutical sector, pharmaceutical companies and organizations can better manage their documents, ensure the document lifecycle during research and development activities, deliver high-quality medicinal products for the pharmaceutical market, minimize the costs, reduce the risks of noncompliance and meet legal obligations. In this context, a sophisticated specific pharmaceutical related electronic document management systems (EDMS) open for paperless documentation new solutions and new horizons in the pharmaceutical area. This thesis presents an updated overview of EDMS system for the readers and professionals in the pharmaceutical industry. It gives information on the regulatory requirements according to various criteria and quality standards for EDMS in the highly regulated pharmaceutical environment and makes them understandable. In addition, special attention is being paid to the regulatory requirements of 21 CRF Part 11 and EU Annex 11 pertaining to electronic records, signatures, audit trials and system validation.
Pages: 55
Annexes: 3