Design of an information system following GMP standards in the pharmaceutical industry

Blaž Lemut (2017) Design of an information system following GMP standards in the pharmaceutical industry. EngD thesis.

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Abstract

Every day, the meaning of information technology increases in all aspects of our daily lives. Due to the fact that in the past twenty years we have witnessed a tremendous increase of information technology being used in the pharmaceutical industry, there is a need to regulate and control it. Agencies around the world which are responsible for protecting animal and public health established that organizations and companies need to follow good manufacturing practices in order to normally operate in the pharmaceutical industry. In the scope of the diploma thesis we first concentrate on the impact of information technology in the pharmaceutical industry, which we then follow up with a summary of the GMP practices and a detailed description of the implementation of a new information system in a pharmaceutical laboratory following generally accepted guidelines.

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