Computerized system validation
Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11[1]) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules
System requirement
Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the system definition phase. System definition artifacts that reflect these requirements can include, but are not limited to, the following:
- User Requirements Specification: Specifies required aims of the system. As opposed to specifying nice-to-have aims of the system.
- Hardware Requirements Specification: Minimum hardware required to support the system.
Computerized system validation vs Computer software assurance
Since the FDA found validation in the pharmaceutical industry is preventing companies from advancing their computer system technology, the FDA are promoting a new concept to ensure pharmaceutical systems are robust. Transferring from computerized system validation toward computer software assurance, Software assurance in this context computer software assurance is a quality assurance activity which builds quality into systems to prevent the manufacture of adulterated pharmaceutical products. This process enhances the value of validating systems by focusing on assurance and confidence rather than documentation.
See also
References
- ^ Commissioner, Office of the (2020-06-11). "Part 11, Electronic Records; Electronic Signatures - Scope and Application". U.S. Food and Drug Administration. Retrieved 2021-09-10.