Benefits from paperless computer system validation in pharmaceutical industry

Simonovski, Nikola and Gjorgjeska, Biljana (2022) Benefits from paperless computer system validation in pharmaceutical industry. Macedonian pharmaceutical bulletin, 68 (1). pp. 123-124. ISSN 1857 - 8969

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Abstract

Computer Systems Validation (CSV) is a process used to ensure that a computer-based systems will produce information or data that meet a set of defined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed.
The concept of validation was first proposed by Ted Byers and Bud Loftus in the mid-1970s to improve the quality of pharmaceutical products. Currently, in the pharmaceutical manufacturing industry, validation plays a vital role in producing high-quality pharmaceutical products that meet good manufacturing practice (GMP) guidelines.
Paperless validation is an electronic process of ensuring that a computer-based systems are compliant to the requirements. All steps of the validation process are registered in digital documents, or items, rather than on paper. By not using a single sheet of paper, the paperless validation presents many benefits to companies, professionals, and the environment. One of them is to convert a most common, system validation such as ERP (Enterprise Resource Planning), which usually uses almost 2,500 sheets of paper, converting it into ‘zero paper’.

Item Type:	Article
Subjects:	Medical and Health Sciences > Health sciences Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Biljana Gorgeska
Date Deposited:	27 Jan 2023 10:10
Last Modified:	27 Jan 2023 10:10
URI:	https://eprints.ugd.edu.mk/id/eprint/30905

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