Integriteta podatkov skozi validacijo računalniško podprtega laboratorijskega sistema

RAMIĆ, JASMIN (author), Solina, Franc (mentor)

Diplomska naloga obravnava zagotavljanje regulatorne skladnosti in validacijo računalniško podprtega laboratorijskega sistema v farmacevtski industriji. Opisuje delovanje in pomen regulatornih organov, pojasnjeni so standardi in primeri dobre prakse, ki se morajo upoštevati v procesu validacije. Z aktivnim uvajanjem zakona na področju elektronskih zapisov in elektronskih podpisov so agencije za prehrano in zdravila uspele postaviti jasne zahteve in smernice v farmacevtski industriji in tako pridobile pravno veljavo. S tem informacijska in računalniška tehnologija postaja pomembno področje v proizvodnji zdravil. V nadaljevanju je skozi primer razvoja validacijske dokumentacije opisan proces validacije računalniško podprtega laboratorijskega sistema od začetka do zaključka, ko tak sistem postane uporaben v reguliranem okolju in ga kot takega lahko sprostimo v produkcijsko okolje. Proces validacije računalniškega sistema je močno povezan s pojmom “integriteta podatkov” in je z vidika regulatornih zahtev ključnega pomena za obstoj farmacevtskega podjetja. Kaj “integriteta podatkov” z vidika regulatornih organov pomeni in kako jo zagotavljamo je opisano v zadnjem delu diplomskega dela. Zaradi kompleksnosti sistemov in stroškov zagotavljanja skladnosti ter vse natančnejših pregledov inšpektorjev je validacija računalniškega sistema v farmacevtski industriji eden izmed ključnih elementov v življenskem ciklu proizvodnje zdravil. S pomočjo validacijskega procesa preprečujemo odstopanja od regulatornih zahtev in tako se podjetje lahko še bolj osredotoči na razvoj in proizvodnjo visoko kakovostnih zdravil.

• Language: Slovenian
• Keywords: validacija, računalniski sistem, regulatorne zahteve, integriteta podatkov
• Work type: Bachelor thesis/paper
• Organization: FRI - Faculty of Computer and Information Science
• Year: 2017
• PID: 20.500.12556/RUL-89001
• Publication date in RUL: 06.02.2017

RAMIĆ, JASMIN, 2017, Integriteta podatkov skozi validacijo računalniško podprtega laboratorijskega sistema [online]. Bachelor’s thesis. [Accessed 24 July 2025]. Retrieved from: https://repozitorij.uni-lj.si/IzpisGradiva.php?lang=eng&id=89001

Secondary language

• Language: English
• Title: Data integrity by validation of a computer based laboratory system

Abstract

The thesis deals with the assurance of regulatory compliance and validation of computer supported laboratory systems in the pharmaceutical industry. It describes the functioning and importance of regulatory authorities and explains the standards and good practice examples to be observed in the validation process. By actively introducing the act on electronic records and signatures, food and drug agencies have succeeded in setting up clear requirements and guidelines in the pharmaceutical industry and thus in gaining their legal validity. Consequently, the information and computer technology are becoming increasingly important in manufacturing pharmaceutical drugs. The described example of the validation documentation development presents the validation process of a computer-supported laboratory system from the beginning to the end, when such a system becomes usable in the regulated environment and it can be released as such in the manufacturing environment. The computer system validation process is strongly connected with the conception of "data integrity" and is of key importance for the existence of a pharmaceutical company from the viewpoint of regulatory requirements. The last part of the thesis focuses on the meaning of "data integrity" from the viewpoint of regulatory authorities and on some methods of how it can be assured. Due to the complexity of such systems, compliance assurance costs, and increasingly severe inspections, the computer system validation in the pharmaceutical industry is one of the key elements within the life cycle of pharmaceutical drug manufacturing. The validation process helps to prevent deviations from regulatory requirements and thus enables the pharmaceutical company to focus more intensively on the development and manufacturing of high quality drugs.

• Keywords: Validation, Computerized System, Regulatory Requirements, Data Integrity