diplomsko delo
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;
Data
Language: |
Slovenian |
Year of publishing: |
2014 |
Typology: |
2.11 - Undergraduate Thesis |
Organization: |
UM FERI - Faculty of Electrical Engineering and Computer Science |
Publisher: |
P. Plut |
UDC: |
004.728.8:661.12(043.2) |
COBISS: |
19130646
|
Views: |
946 |
Downloads: |
154 |
Average score: |
0 (0 votes) |
Metadata: |
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Other data
Secondary language: |
English |
Secondary title: |
Incremental person recognition using reasoning approach |
Secondary 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. |
Secondary keywords: |
validation;GAMP;V-model;critical assessment of computerized system; |
URN: |
URN:SI:UM: |
Type (COBISS): |
Bachelor thesis/paper |
Thesis comment: |
Univ. v Mariboru, Fak. za elektrotehniko, računalništvo in informatiko, Računalništvo in informacijske tehnologije |
Pages: |
VII, 39 str. |
ID: |
9063603 |