A Review on Computer System Validation (CSV) and Recent Computer System Violations Leading to USFDA Warning Letter for the Pharmaceutical Industry

Abstract: Validating computer systems is crucial to meet regulatory requirements, as the lack of proper system integrity can lead to USFDA 483 warning letters. Over the past 5 years, approximately 50 warning letters have been issued for violating computer system requirements, with major comments. Computer System Validation (CSV) is an evaluation process used to test and ensure that the computerized systems used in the pharmaceutical industry are fit for their intended use and meet all regulatory requirements. The major regulations for computer system validation are GAMP and 21 CFR Part 11. In the 1990s, GAMP was established, which mainly focused on the computer systems in industries. Later, 21 CFR Part 11 was issued by the US FDA in 2002. The mainstream and most effective way of computer system validation begins with planning and concludes with result reporting. For a new computer system, its effect on product quality should be checked first; if the system affects the product quality, then system validation is required. If product quality is not affected, then system validation is not required. Various tools can be used for validating different kinds of computer systems. Some of these tools include risk assessment Tools, FEMA, Testing and Validation Tools, Document Management Tools, Change Control Management Tools, Data Management Tools, and Analytics Tools.