Implementing laboratory computerized systems in pharmaceutical industry : regulatory compliance

Peklaj, Kristian (author), Cerovšek, Mitja (author)

The implementation of computerized systems in pharmaceutical industry must meet the compliance with regulatory requirements, assure high level of data integrity (DI) and product quality. This study reviews European legislation, the European and U.S. pharmacopoeias, and global guidelines, such as GAMP 5 and ALCOA++, to identify the necessary standards and best practices. Key directives of European and U.S legalisation emphasize the importance of system validation, quality risk management and secure data handling. The study highlights validation processes categorized by system complexity according to GAMP 5. Additionally, guidelines like ALCOA++ provide a robust framework for achieving DI throughout the data lifecycle. By adhering to these requirements, pharmaceutical manufacturers can ensure regulatory compliance, maintain high-quality standards and safeguard patient safety.

• Language: English
• Keywords: compliance, computerized systems, data integrity, GAMP 5, regulations, pharmacy, validation
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FS - Faculty of Mechanical Engineering
• Publication status: Published
• Publication version: Version of Record
• Year: 2025
• Number of pages: Str. 26-32
• Numbering: Letn. 31, št. 1
• PID: 20.500.12556/RUL-167819
• UDC: 615:34
• ISSN on article: 1318-7279
• COBISS.SI-ID: 228730115
• Publication date in RUL: 13.03.2025

Record is a part of a journal

• Title: Ventil : revija za fluidno tehniko in avtomatizacijo
• Shortened title: Ventil
• Publisher: Univerza v Ljubljani, Fakulteta za strojništvo
• ISSN: 1318-7279
• COBISS.SI-ID: 54233856

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Title: Regulativna skladnost ob implementaciji laboratorijskih računalniških sistemov v farmacevtski industriji

Abstract

Implementacija računalniških sistemov v farmacevtski industriji mora zagotavljati skladnost z regulativnimi zahtevami, visok nivo integritete podatkov ter kakovost izdelkov. Študija pregleduje evropsko zakonodajo, evropsko in ameriško farmakopejo ter globalne smernice, kot sta GAMP 5 in ALCOA++, da bi opredelila potrebne standarde in najboljše prakse. Ključne direktive evropske in ameriške zakonodaje poudarjajo pomen validacije sistemov, upravljanja tveganj kakovosti in varnega ravnanja s podatki. Študija izpostavlja procese validacije, razvrščene glede na kompleksnost sistema v skladu z GAMP 5. Poleg tega smernice,kot so ALCOA++, zagotavljajo trden okvir za doseganje integritete podatkov skozi njihov celotni življenjski cikel. S študijo želimo ugotoviti, ali lahko ob upoštevanju smernic farmacevtski proizvajalci zagotovijo regulatorno skladnost, vzdržujejo visoke standarde kakovosti in zagotavljajo varnost pacientov.

• Keywords: skladnost, računalniški sistemi, integriteta podatkov, GAMP 5, regulative, farmacija, validacija