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The role of computer science in the pharmaceutical industry and validation of computer systems according to 21 CFR Part 11 norm
Matej Lončar (2017)
Josip Juraj Strossmayer University of Osijek
Faculty of Electrical Engineering, Computer Science and Information Technology Osijek
Department of Software Engineering
Chair of Visual Computing
Cite this document

Lončar, M. (2017). Uloga računarstva u farmaceutskoj industriji i validacija računalnih sustava prema 21 CFR Part 11 normi (Master's thesis). Retrieved from https://urn.nsk.hr/urn:nbn:hr:200:908060

Lončar, Matej. "Uloga računarstva u farmaceutskoj industriji i validacija računalnih sustava prema 21 CFR Part 11 normi." Master's thesis, Josip Juraj Strossmayer University of Osijek, Faculty of Electrical Engineering, Computer Science and Information Technology Osijek, 2017. https://urn.nsk.hr/urn:nbn:hr:200:908060

Lončar, Matej. "Uloga računarstva u farmaceutskoj industriji i validacija računalnih sustava prema 21 CFR Part 11 normi." Master's thesis, Josip Juraj Strossmayer University of Osijek, Faculty of Electrical Engineering, Computer Science and Information Technology Osijek, 2017. https://urn.nsk.hr/urn:nbn:hr:200:908060

Lončar, M. (2017). 'Uloga računarstva u farmaceutskoj industriji i validacija računalnih sustava prema 21 CFR Part 11 normi', Master's thesis, Josip Juraj Strossmayer University of Osijek, Faculty of Electrical Engineering, Computer Science and Information Technology Osijek, accessed 14 November 2019, https://urn.nsk.hr/urn:nbn:hr:200:908060

Lončar M. Uloga računarstva u farmaceutskoj industriji i validacija računalnih sustava prema 21 CFR Part 11 normi [Master's thesis]. Osijek: Josip Juraj Strossmayer University of Osijek, Faculty of Electrical Engineering, Computer Science and Information Technology Osijek; 2017 [cited 2019 November 14] Available at: https://urn.nsk.hr/urn:nbn:hr:200:908060

M. Lončar, "Uloga računarstva u farmaceutskoj industriji i validacija računalnih sustava prema 21 CFR Part 11 normi", Master's thesis, Josip Juraj Strossmayer University of Osijek, Faculty of Electrical Engineering, Computer Science and Information Technology Osijek, Osijek, 2017. Available at: https://urn.nsk.hr/urn:nbn:hr:200:908060

Metadata
TitleUloga računarstva u farmaceutskoj industriji i validacija računalnih sustava prema 21 CFR Part 11 normi
Title (english)The role of computer science in the pharmaceutical industry and validation of computer systems according to 21 CFR Part 11 norm
AuthorMatej Lončar
MentorDean Vučinić (mentor)
MentorMirko Kohler (mentor)
Committee memberDean Vučinić (predsjednik povjerenstva)
Committee memberIvica Lukić (član povjerenstva)
Committee memberMirko Kohler (član povjerenstva)
GranterJosip Juraj Strossmayer University of Osijek
Faculty of Electrical Engineering, Computer Science and Information Technology Osijek
(Department of Software Engineering)
(Chair of Visual Computing)
Osijek
Defense date and country2017, Croatia
Scientific / art field,
discipline and subdiscipline		TECHNICAL SCIENCES
Computing
Process Computing
Abstract
U ovom je radu dan pregled rada računalnog sustava koji se koristi u farmaceutskoj industriji,kao i njegovih podsustava (informacijski, laboratorijski i procesni sustav). Dan je pregledkako se i zašto moraju validirati pojedini računalni sustavi. Također, prikazan je postupakvalidacije računalnog sustava (prema GAMP-u 5) i svih njezinih dijelova: Specifikacijazahtjeva korisnika (URS), Kvalifikacija dizajna (DQ), Kvalifikacija instalacija (IQ),Kvalifikacija operacija (OQ) i Kvalifikacija rada (PQ). Objašnjeno je i kako održavatiračunalni sustav u validiranom stanju. Ukoliko je potrebno validirati računalni sustav,potrebno je to učiniti prema 21 CFR Part 11 gdje su dane smjernice koji zahtjevi moraju bitiispunjeni kako bi se zadovoljio FDA standard. U praktičnom dijelu rada prikazan je postupakvalidacije računalnog sustava u farmaceutskoj industriji koji, u ovom slučaju, nema utjecaj nazdravlje pacijenta
Abstract (english)
In this paper, a review of computer system used in pharmaceutical industry is given, as wellas its subsystems (informational, laboratory and process system). It is reviewed how and whyspecific computer systems are validated. It also shows a procedure of computer systemvalidation (according to GAMP 5) and all its parts, and those are: User request specification(URS), Design qualification (DQ), Installation qualification (IQ), Operation qualification(OQ) and Performance qualification (PQ). It is explained how to keep computer system invalidated state. If computer system needs to be validated according to 21 CFR part 11 youcan find guidelines on requests that need to be fulfilled to satisfy FDA standard. In practicalpart of this paper I have shown a procedure for validation of computer system inpharmaceutical industry which in this case does not affect patient health
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:200:908060
Study programmeTitle: Graduate University Study Programme in Computer Engineering
Study programme type: university
Study level: graduate
Academic / professional title: magistar/magistra inženjer/inženjerka računarstva (magistar/magistra inženjer/inženjerka računarstva)
Type of resourceText
File originBorn digital
Access conditionsOpen access
Terms of usehttp://rightsstatements.org/vocab/InC/1.0/
Created on2017-01-18 17:44:05