Oblikovanje sistema kakovosti za validacijo računalniških sistemov – primer farmacevtske industrije
DOI:
https://doi.org/10.37886/Ključne besede:
sistem kakovosti, validacija računalniških sistemov, farmacevtska industrijaPovzetek
Raziskovalno vprašanje (RV): Raziskovalno vprašanje članka je, kateri so osnovni elementi sistema kakovosti validacije računalniških sistemov, ki jih zahtevata evropska in ameriška zakonska ureditev farmacevtske industrije.
Namen: Namen članka je prikazati oblikovanje sistema kakovosti za validacijo računalniških sistemov v farmacevtski industriji, ki bo skladen z evropskimi in ameriškimi zakonskimi zahtevami.
Metoda: S pomočjo deskriptivne metode in metode komparacije prikažemo evropske in ameriške zakonske zahteve. S pomočjo metode klasifikacije ugotovimo osnovne elemente sistema kakovosti in jih na podlagi medsebojne primerjave evropske in ameriške zakonodaje z metodo kompilacije opredelimo.
Rezultati: Opredelitev elementov v obliki splošnih in temeljnih postopkov, ki jih mora organizacija opredeliti in vpeljati za vzpostavitev sistema kakovosti. Za primer smo vzeli farmacevtsko industrijo, ker je le ta zaradi zagotavljanja varnosti uporabnikov zdravil podvržena strogim zakonskim zahtevam.
Družba: V članku prikazan sistem je lahko osnova za vsa podjetja, v katerih imajo računalniški sistemi pomembno vlogo in je zato vzpostavitev sistema kakovosti za njihovo validacijo nujen pogoj ustreznega obvladovanja računalniških sistemov.
Organizacija: Prikazan sistem je osnova za dejansko izvajanje posameznih validacij računalniških sistemov v konkretnem podjetju.
Originalnost: V literaturi nismo zasledili opredelitev elementov sistema kakovosti za validacijo računalniških sistemov.
Omejitve/nadaljnje raziskovanje: Glavna omejitev prikazanega sistema kakovosti je, da je oblikovan za farmacevtsko panogo, ki je zaradi svoje narave močno regulirana. Nadaljnje delo mora biti usmerjeno v testiranje primernosti oblikovanega sistema z njegovo uporabo na konkretnih primerih znotraj farmacevtske industrije in v analizo potrebnih prilagoditev/ poenostavitev oblikovanega sistema za manj regulirane dejavnosti.
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