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 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.