Validation of computerized systems category 4 and 5 according to good automation manufacturing practice

Simonovski, Nikola (2023) Validation of computerized systems category 4 and 5 according to good automation manufacturing practice. Doctoral thesis, Goce Delcev University - Stip.

Text PhD_Thessis_Валидација на компјутеризирани системи од категорија 4 и 5 според Добрата автоматизирана производна практика-лекторирано.pdf Download (1MB)

Abstract

Pharmaceutical industry is one of the most regulated industries in the world. Quality assurance in the pharmaceutical industry is a broad concept that encompasses all topics that affect product quality, either individually or collectively. Quality assurance refers to a set of operations aimed at ensuring the necessary quality of pharmaceutical products. Computerized systems validation (CSV) is a process used to test, confirm, and formally document that a regulated computerized system performs exactly what it was designed to do in a consistent and accurate manner that is safe, reliable, and traceable. A risk-based approach to computerized system validation is a regulatory requirement. Because there are so many distinct types and categories of computerized systems in the pharmaceutical industry, the approach to validation planning and the validation process is different and unique for each system.
The focus is put on Category 4 (configured computerized systems) and Category 5 (custom or bespoke computerized systems), which are the most implemented and validated in the pharmaceutical industry, emphasizing the advantages and disadvantages of implementing a system that is categorized as a Category 4 or 5 system.

Keywords: computerized, system, validation, risk-based, GAMP (Good Automated Manufacturing Practice)

Item Type:	Thesis (Doctoral)
Subjects:	Natural sciences > Computer and information sciences Engineering and Technology > Medical engineering Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Biljana Gorgeska
Date Deposited:	27 Dec 2023 08:16
Last Modified:	27 Dec 2023 08:16
URI:	https://eprints.ugd.edu.mk/id/eprint/33132

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