Abstract

COMPUTERISED SYSTEM VALIDATION: REGULATORY COMPLIANCE AND PHARMACEUTICAL INDUSTRY

Shaik Abida*, G. Ramakrishna and M. V. Nagabhushanam

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Abstract

Computerised System Validation (CSV) is a critical process in the pharmaceutical industry, ensuring that computer-based systems used in the manufacture, testing, and distribution of pharmaceutical products operate in a consistent and compliant manner. This review highlights the principles of CSV, its role in meeting regulatory expectations, and its application across the pharmaceutical sector. Emphasis is placed on Good Automated Manufacturing Practice (GAMP), data integrity, and the alignment with regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines.

Keywords: Computerised System Validation (CSV), Pharmaceutical industry, pharmaceutical products, Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines.