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Thursday, August 11, 2011

Data-Handling Software for a GLP Environment: Development and Validation Requirements
As the use of digital computers escalated over the past forty years the financial costs of software failure increased correspondingly, and the importance of software testing grew.
Software development and validation are simultaneous processes. The processes of software testing start at the birth of the product and go on during the whole of its construction. Verification and validation are difficult because a developer cannot test the software forever and it is hard to estimate how much evidence is sufficient.
When applied to a computer system, validation, as defined by the FDA, can be interpreted as documented evidence, which provides a high degree of assurance that a computer system performs its intended functions accurately and reliably.1
The standard definition of verification is based on the question "are we building the product right?" (i.e., assuring that the software is developed correctly). The software should perform to predefined specifications and an analysis is done to ensure that all required specifications are met. Validation is the process of finding out "whether the product being built is right" (i.e., it should do what the user expects it to do, meaning it should satisfy all functional requirements set by the user). Validation is done during and at the end of the software development process.
N. Matthijs , B. Dejaegher , Y. Vander Heyden.
LCGC Europe, 01 December 2006.


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