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Title:Zagotavljanje neprekinjenosti delovanja track and trace sistema v proizvodnji izbranega farmacevtskega podjetja
Authors:ID Gašperšič, Matija (Author)
ID Jereb, Borut (Mentor) More about this mentor... New window
ID Orel Šanko, Nena (Comentor)
Files:.pdf UN_Gaspersic_Matija_2025.pdf (5,83 MB)
MD5: 9A9AA701B4E30A2987280856F9FB52C6
 
Language:Slovenian
Work type:Bachelor thesis/paper
Typology:2.11 - Undergraduate Thesis
Organization:FL - Faculty of Logistic
Abstract:Diplomsko delo obravnava zagotavljanje neprekinjenosti delovanja sistema za sledenje (angl. Track and Trace, v nadaljevanju: T&T) v proizvodnji farmacevtskih izdelkov v izbranem podjetju. V teoretičnem delu so predstavljeni pomen sledljivosti izdelkov v farmacevtski industriji, načini upravljanja informacijskih tehnologij ter okvir nadzornih ciljev za informacijsko in sorodno tehnologijo (angl. Control Objectives for Information and Related Technologies, v nadaljevanju: COBIT) 2019, katerega uporaba se obravnava z vidika razpoložljivosti in neprekinjenosti delovanja. V raziskovalnem delu je bila izvedena analiza obstoječega stanja sistema T&T po korakih dela okvira COBIT 2019, namenjenega upravljanju neprekinjenosti. Analiza temelji na teoretičnih izhodiščih ter podatkih, pripravljenih v okviru študije primera na osnovi razpoložljive dokumentacije in opisov procesov, obdelanih za potrebe diplomske naloge. Prepoznana so bila ključna tveganja, kot so enojne točke odpovedi, nezadostna frekvenca varnostnega kopiranja ter omejeno usposabljanje zaposlenih. Oblikovani so bili tehnični in organizacijski ukrepi, med drugim odprava enojnih točk odpovedi v kritičnih komponentah sistema, pogostejše varnostno kopiranje, izboljšano upravljanje dostopov zunanjih izvajalcev ter dodatna usposabljanja zaposlenih. Predlagani ukrepi povečujejo zanesljivost sistema ter zmanjšujejo vpliv izpadov na proizvodnjo, kakovost in skladnost izdelkov.
Keywords:sistem sledljivosti, neprekinjenost delovanja, farmacevtska proizvodnja, informacijska tehnologija, COBIT 2019
Place of publishing:Maribor
Publisher:[M. Gašperšič]
Year of publishing:2025
PID:20.500.12556/DKUM-95044 New window
UDC:658.5(043.2)
COBISS.SI-ID:252229891 New window
Publication date in DKUM:08.10.2025
Views:177
Downloads:14
Metadata:XML DC-XML DC-RDF
Categories:FL
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Licences

License:CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Link:http://creativecommons.org/licenses/by-nc-nd/4.0/
Description:The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.
Licensing start date:02.09.2025

Secondary language

Language:English
Title:Ensuring business continuity of the track and trace system in the production of a selected pharmaceutical company
Abstract:This thesis addresses business continuity for the Track and Trace system (T&T) in pharmaceutical manufacturing within a selected company. The theoretical part presents the importance of product traceability in the pharmaceutical industry, approaches to IT management, and the COBIT 2019 framework, whose application is considered from the perspective of availability and continuity. In the research part, an analysis of the current state of the T&T system was carried out by following the steps of the COBIT 2019 framework for business continuity management. The analysis is based on theoretical foundations and on data prepared within the case study using available documentation and process descriptions processed for the purposes of the thesis. Key risks were identified, such as single points of failure, insufficient backup frequency, and limited employee training. Technical and organizational measures were proposed, including eliminating single points of failure in critical components, more frequent backups, improved access management for external contractors, and additional employee training. The proposed measures increase system reliability and reduce the impact of outages on production, quality, and regulatory compliance.
Keywords:Track and Trace, business continuity, pharmaceutical manufacturing, information technology, COBIT 2019


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