Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Informatics and Labelling Management Systems - Recent Developments and Description of a State-of-the-Art Labelling Management Software in the Pharmaceutical Industry ***

Justin-Christopher Bell (Abschlußjahr: 2023)

Summary
Language: English
Document Management (DM), sometimes referred to as Enterprise Content Management (ECM), is a concept that is widely used by companies in order to control and manage the steadily increasing number of paper and electronic documents. This is also the case for the pharmaceutical industry. However, many companies operate an overarching ‘one-size-fits-all’ Document Management systems (DMS) for all departments that does not fit all individual department’s needs. Other enterprises only use a DMS in certain departments or for certain tasks, e.g. for accounting or for procurement.
This thesis points to the importance of a state-of-the-art Labelling Management system for PI handling within RA departments. The technical specifications, functionalities and non-technical requirements that are needed for state-of-the-art Labelling DMS are elaborated through an in-depth market analysis of the DM/ECM applications on the market. The market analysis provides a scientifically based list of ‘must’ and ‘want’ specifications for a suitable DMS for the management of PI documents. However, the evaluation of the market analysis has also shown that selecting the right software solution also depends highly on the pharmaceutical company’s special needs and the needs of future users in that company.
In addition, an analysis of Regulatory Informatics (RI) projects in the EU concludes that for each new IT software solution to be implemented in RA departments, there are specific requirements for interoperability and harmonization of data sets and systems. The electronic Product Information (ePI) project and the International Organisation for Standardisation (ISO) Identification of Medicinal Products (IDMP) implementation via the Substance, Product, Organization, Referentials (SPOR) master data system are important RI projects that must be considered with any new Labelling management software, as they place special requirements on PI management tools.
All in all, the results clearly show that a software solution with a specialized set of functionalities, technical specifications and vendor services is needed to meet the requirements of a state-of-the-art Labelling management software. When selecting an ‘off-the-shelf’ DMS/ECM solution for PI document handling, adjustment programming is required to fulfil all the requirements for a proper PI management.
Pages: 86
Annexes: 7, Pages: 26