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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
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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 20 February 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 February 20] 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
AuthorMatej Lončar
Mentor(s)Dean Vučinić (thesis advisor)
Mirko Kohler (thesis advisor)
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
Keywords21 CFR Part 11 computer system GAMP 5 pharmaceutical industry validation
Parallel title (English)The role of computer science in the pharmaceutical industry and validation of computer systems according to 21 CFR Part 11 norm
Committee MembersDean Vučinić (committee chairperson)
Ivica Lukić (committee member)
Mirko Kohler (committee member)
GranterJosip Juraj Strossmayer University of Osijek
Faculty of Electrical Engineering, Computer Science and Information Technology Osijek
Lower level organizational unitsDepartment of Software Engineering
Chair of Visual Computing
PlaceOsijek
StateCroatia
Scientific field, discipline, subdisciplineTECHNICAL SCIENCES
Computing
Process Computing
Study programme typeuniversity
Study levelgraduate
Study programmeGraduate University Study Programme in Computer Engineering
Academic title abbreviationmag.ing.comp.
Genremaster's thesis
Language Croatian
Defense date2017
Parallel 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
Parallel keywords (Croatian)21 CFR Part 11 farmaceutska industrija GAMP5 računalni sustav validacija
Resource typetext
Access conditionOpen access
Terms of usehttp://rightsstatements.org/vocab/InC/1.0/
URN:NBNhttps://urn.nsk.hr/urn:nbn:hr:200:908060