The Essential Guide to Computer System Validation in the Pharmaceutical Industry

This review aims to provide an essential guide to computer system validation (CSV) in the pharmaceutical industry. CSV is a process for ensuring that computer-based systems produce data and information that meets a set of pre-defined requirements. The pharmaceutical industry relies on data integrity...

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Bibliographic Details
Published in:Curēus (Palo Alto, CA) CA), 2024-08, Vol.16 (8), p.e67555
Main Authors: Raja, Jawahar Rohith, Kella, Alekhya, Narayanasamy, Damodharan
Format: Article
Language:English
Subjects:
Automation
Compliance
Computer peripherals
Design specifications
Distributed control systems
Documentation
Enterprise resource planning
Good Manufacturing Practice
Healthcare Technology
Manufacturing
Other
Personal computers
Pharmaceutical industry
Product quality
Product testing
Quality Improvement
Quality standards
Raw materials
Software
Software development
Systems development
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Summary:This review aims to provide an essential guide to computer system validation (CSV) in the pharmaceutical industry. CSV is a process for ensuring that computer-based systems produce data and information that meets a set of pre-defined requirements. The pharmaceutical industry relies on data integrity to ensure reliable, accurate, and consistent information throughout the product lifecycle. Nowadays, since CSV plays an important role in the production and the final stages of a product, it is vital to ensure the reliability of the computer system, ensuring that it meets predefined requirements. The life cycle of CSV starts from the planning stage to the modification stage. Validation involves design, installation, operational, and performance qualifications (PQ), starting with a master plan and ending with periodic system reviews. Failure to validate the computer system leads to various regulatory compliances. Validating computer systems offers numerous benefits, including improved quality, reduced validation costs and time, and improved GMP compliance with 21 CFR part 11 regulations. Validating the computer system significantly affects how well, securely, and accurately products are made, ensuring they meet GxP requirements.
ISSN:2168-8184
2168-8184
DOI:10.7759/cureus.67555