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Title:ŠTUDIJ ZAHTEV PROCESA RAZVOJA PROGRAMSKE OPREME IN IMPLEMENTACIJA SPLETNE APLIKACIJE V FARMACEVTSKEM PODJETJU
Authors:ID Plut, Peter (Author)
ID Zorman, Milan (Mentor) More about this mentor... New window
Files:.pdf UNI_Plut_Peter_2014.pdf (3,29 MB)
MD5: 6180FF314B9AC5E790D146E472F34BD2
 
Language:Slovenian
Work type:Bachelor thesis/paper
Typology:2.11 - Undergraduate Thesis
Organization:FERI - Faculty of Electrical Engineering and Computer Science
Abstract:Diplomsko delo obravnava dva mednarodno uveljavljena pravilnika, CFR 21 poglavje 11 in Aneks 11. Opisani so dobra praksa GAMP, ki je osnova za validacijo računalniških sistemov, in faze, ki nastopajo v validaciji programske opreme. Validacija je predstavljena na konkretnem primeru razvoja spletne aplikacije v farmacevtskem podjetju Krka, d. d., Novo mesto.
Keywords:validacija, GAMP, V-model, kritičnost računalniškega sistema
Place of publishing:[Maribor
Publisher:P. Plut
Year of publishing:2014
PID:20.500.12556/DKUM-45286 New window
UDC:004.728.8:661.12(043.2)
COBISS.SI-ID:19130646 New window
NUK URN:URN:SI:UM:DK:LJ8AYMLN
Publication date in DKUM:06.11.2015
Views:1579
Downloads:201
Metadata:XML DC-XML DC-RDF
Categories:KTFMB - FERI
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Secondary language

Language:English
Title:REQUIREMENTS STUDY OF SOFTWARE DEVELOPMENT PROCESS AND IMPLEMENTATION OF WEB APPLICATION IN A PHARMACEUTICAL COMPANY
Abstract:This thesis deals with two internationally established regulations – CFR 21 part 11 and Annex 11. It also considers rules of best practice GAMP, which is the groundwork for computer system validation and phases that appear in software validation process. The latter is presented on a solid case of web application in a pharmaceutical company Krka, d. d., Novo mesto.
Keywords:validation, GAMP, V-model, critical assessment of computerized system


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