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Nadzor upravljanja dokumentacijom u farmaceutskim tvrtkama


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Perko, Toni. (2016). Nadzor upravljanja dokumentacijom u farmaceutskim tvrtkama. Diploma Thesis. Filozofski fakultet u Zagrebu, Department of Information Science > Chair of Archivistics . [mentor Rajh, Arian].

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This master’s thesis provides an overview of documentation management in pharmaceutical companies. The author begins the paper with a short introduction into the documents and regulations that are aimed at the pharmaceutical industry, after which he provides an analysis of the ISO standard 17025:2007 and the Good Manufacturing Practices. While analyzing the two documents, the author focuses primarily on the chapters concerned with documentation and records management. The paper explains and discusses the needs and regulations for records keeping. After the author introduces the terms of documentation management, he writes about the agencies in charge of auditing pharmaceutical companies and their role in documentation management is described and analyzed. The author gives special attention to the retention period of archival documentation that was produced by pharmaceutical companies. As a display of importance of documentation management, the author provides a brief analysis of the job market for documentation specialist in the pharmaceutical industry.

Item Type: Diploma Thesis
Uncontrolled Keywords: ISO 17025:2007, GMP, FDA, HALMED, supervision, documentation, record, regulation, management, law, regulations, jobs
Subjects: Information sciences > Archivistics and documentation
Departments: Department of Information Science > Chair of Archivistics
Supervisor: Rajh, Arian
Date Deposited: 18 Apr 2016 13:44
Last Modified: 18 Apr 2016 13:44

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