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Title:VALIDACIJA RAČUNALNIŠKIH SISTEMOV SKOZI UVEDBO CELOVIITIH INFORMACIJSKIH REŠITEV
Authors:ID Erznožnik, Tom (Author)
ID Sternad Zabukovšek, Simona (Mentor) More about this mentor... New window
Files:.pdf MAG_Erznoznik_Tom_2015.pdf (1,03 MB)
MD5: FCD15B7EFA7CE777D1C57AE79807D0B4
 
Language:Slovenian
Work type:Master's thesis/paper
Typology:2.09 - Master's Thesis
Organization:EPF - Faculty of Business and Economics
Abstract:V magistrskem delu je prikazan postopek validacije v farmacevtski industriji. Opisani in pojasnjeni so zakonski predpisi, standardi in primeri dobre prakse, ki se morajo pri sami validaciji upoštevati. Navedeni so postopki, kvalifikacije in dokumentacija, ki mora v procesu nastati. Posebna pozornost je namenjena postopku validacije računalniških sistemov oz. celovitih informacijskih rešitev. Postopek validacije je opisan v sklopu posamezne faze uvedbe celovite informacijske rešitve. Po fazah življenjskega cikla so navedene validacijske aktivnosti, ki se morajo izvesti, da celovita informacijska rešitev lahko dobi naziv validirane rešitve. V magistrskem delu so omenjeni tudi postopki ravnanja z validirano rešitvijo po uvedbi celovite informacijske rešitve. Spremembe po uvedbi je potrebno ustrezno evidentirati, da rešitev obdrži status validiranega sistema. Tudi upokojitev sistema mora biti primerno dokumentirana in izvedena po protokolu. Sama validacija mnogim organizacijam povzroča veliko breme, saj je časovno zelo potratna, posledično pa je uvedba celovite informacijske rešitve veliko dražja. Zato smo v magistrskem delu predstavili prednosti in namen validacije celovite informacijske rešitve, ki lahko upraviči višje stroške.
Keywords:Validacija, Prednosti Validacije, Postopek validacije, Celovite informacijske rešitve, Uvajanje celovitih informacijskih rešitev, Kvalifikacija namestitve, Kvalifikacija obratovanja, Kvalifikacija delovanja, Validacijski načrt, Validacijski protokol, Specifikacija uporabniških zahtev.
Place of publishing:Maribor
Publisher:[T. Erznožnik]
Year of publishing:2015
PID:20.500.12556/DKUM-54768 New window
UDC:659.2:004
COBISS.SI-ID:12128028 New window
NUK URN:URN:SI:UM:DK:E3TCKOSX
Publication date in DKUM:09.11.2015
Views:2613
Downloads:361
Metadata:XML DC-XML DC-RDF
Categories:EPF
:
ERZNOŽNIK, Tom, 2015, VALIDACIJA RAČUNALNIŠKIH SISTEMOV SKOZI UVEDBO CELOVIITIH INFORMACIJSKIH REŠITEV [online]. Master’s thesis. Maribor : T. Erznožnik. [Accessed 12 April 2025]. Retrieved from: https://dk.um.si/IzpisGradiva.php?lang=eng&id=54768
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Secondary language

Language:English
Title:COMPUTER SYSTEM VALIDATION IN AN ERP IMPLEMENTATIONS
Abstract:This masters work describes computer system validation in pharmaceutical industry, explains the legal regulations, standards and best practices that should be taken into account in the actual validation. It also mentions the procedures, qualifications and documentations, which must be implemented in the process. Special attention is devoted to the procedure of computer system validation. The validation process is described in the context of individual implementation phase. Validation activities are set according to the life cycle stages. All validation activities must be implemented into integrated information solutions, so that ERP solution can be titled as validated solution. In this masters work we have also mentioned how validated ERP solution should be handled after the implementation. Changes, following the implementation, should be properly recorded and documented, so that the ERP solution retains the status of a validated system. Even the ERP solution retirement must be properly documented and conducted according to the protocol. System validation represents a significant burden to many organizations, because it is very time consuming and consequently, the implementation of ERP solution is much more expensive. Therefore, in the masters work we have presented the benefits and purpose of the validation of ERP solution, which can justify the higher cost.
Keywords:Validation, Validation Benefits, Validation Process, Enterprise Resource Planning, Enterprise Resource Planning Implementation, Installation Qualification, Operational Qualification, Performance Qualification, Validation Plan, Validation Protocol, User Requirement Specification.


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