Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11
) 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:
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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.
See also
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Software testing
Software testing is the act of examining the artifacts and the behavior of the software under test by validation and verification. Software testing can also provide an objective, independent view of the software to allow the business to apprecia ...
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Software engineering
Software engineering is a systematic engineering approach to software development.
A software engineer is a person who applies the principles of software engineering to design, develop, maintain, test, and evaluate computer software. The term '' ...
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List of software engineering topics
The following outline is provided as an overview of and topical guide to software engineering:
Software engineering – application of a systematic, disciplined, quantifiable approach to the development, operation, and maintenance of software ...
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Quality assurance
References
External links
Guidance Compliance Regulatory Information
{{DEFAULTSORT:Computerized System Validation
Quality control
Software quality