COMPUTERIZED SYSTEM VALIDATION – A REVIEW Authors: Savitha S* And Kathiresan K
ABSTRACT
In the pharmaceutical industry, computers are an integral part of day-to-day operations.
In the last 20 years, data administration in the GMP area has transitioned from paper-based
approaches to computerized solutions. We use an established, effective, and controlled
computer system to improve the integrity of our quality assurance system. Software issues can
have a negative impact on environmental production and result in a drop in product quality.
Validation assessment is required in the pharmaceutical industry to assure compliance with
medication cGMP criteria and consistent quality.
Keywords: Computer System Validation, Life cycle model, Requirements of Regulated
Electronic Records, Qualification of CSV
Publication date: 01/11/2022 https://ijbpas.com/pdf/2022/November/MS_IJBPAS_2022_6567.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.11.6567
