Computerized system validation
Encyclopedia
Computer system validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner.
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.
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:
The formal definition of validation
from the US Food and Drug Administration (FDA) is:
“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” (Source: FDA Guidelines on General Principles of Process Validation, 1987) [Phil Latham, Director, MNL Limited, www.mnl-limited.com 5/7/06]
See also: www.mnl-limited.com/services.htm for a full explanation of CSV. [Phil Latham, Director, MNL Limited, www.mnl-limited.com 5/7/06]
IT Pharma Validation Organizations: www.it-validation.eu http://www.it-validation.eu or www.it-validation.org http://www.it-validation.org
GAMP Guide: www.ispe.org http://www.ispe.org
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 requirements
Documented system requirementsSystem requirements
To be used efficiently, all computer software needs certain hardware components or other software resources to be present on a computer. These pre-requisites are known as system requirements and are often used as a guideline as opposed to an absolute rule. Most software defines two sets of system...
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: Details each feature of the system.
- Hardware Requirements Specification: Minimum hardware required to support the system.
The formal definition of validation
Validation (drug manufacture)
Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...
from the US Food and Drug Administration (FDA) is:
“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” (Source: FDA Guidelines on General Principles of Process Validation, 1987) [Phil Latham, Director, MNL Limited, www.mnl-limited.com 5/7/06]
See also
- Software testingSoftware testingSoftware testing is an investigation conducted to provide stakeholders with information about the quality of the product or service under test. Software testing can also provide an objective, independent view of the software to allow the business to appreciate and understand the risks of software...
- Software engineeringSoftware engineeringSoftware Engineering is the application of a systematic, disciplined, quantifiable approach to the development, operation, and maintenance of software, and the study of these approaches; that is, the application of engineering to software...
- List of software engineering topics
- Quality AssuranceQuality AssuranceQuality assurance, or QA for short, is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the production process...
See also: www.mnl-limited.com/services.htm for a full explanation of CSV. [Phil Latham, Director, MNL Limited, www.mnl-limited.com 5/7/06]
IT Pharma Validation Organizations: www.it-validation.eu http://www.it-validation.eu or www.it-validation.org http://www.it-validation.org
GAMP Guide: www.ispe.org http://www.ispe.org