Computerized System Validation (CSV) is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
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: Almost all computer software requires some features to be present on a computer system before it can be used with the computer. ...
User Requirements Specification: What the system needs to do for its user(s)
Functional Requirements Specification: How each feature of the system functions
Design Requirements Specification: How each feature of the system is built
Hardware Requirements Specification: Minimum hardware required to support the system
See also: http://www.mnl-limited.com/services.htm for a full explanation of CSV. [Phil Latham 5/7/06] Software testing is the process used to help identify the correctness, completeness, security and quality of developed computer software. ... Software engineering (SE) is the profession of people who create and maintain software systems by applying technologies and practices from computer science, project management, engineering, application domains and other fields. ... This list complements the software engineering article, giving more details and examples. ... In engineering and manufacturing, quality control or quality engineering is a set of measures taken to ensure that defective products or services are not produced, and that the design meets performance requirements. ...
In the past, vendors who submitted their computerizedsystems to this type of review and were found to be satisfactory, received a letter stating that FDA found the computerizedsystem, as evaluated, to meet the intent of the regulations.
Computerizedsystems are used not only for the generation of LACF processing records, but for control functions such as: formulation control, process deviation calculations, process temperature, process pressure, process timing and container closure examination.
However; as long as the computerizedsystem controls or records part of or the entirety of a manufacturing process, the manufacturer is responsible for establishing that the computerizedsystem functions as it was intended to function.
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