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].
Abstract
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 |
| URI: |
http://darhiv.ffzg.unizg.hr/id/eprint/6347 |
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