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Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. In the field of computer science, the term means the ability of software to meet its stated requirements. For the FDA, validation of a computer system incorporates all activities that go into a computer system and these should be documented and made available to the FDA. We could use the word “verification” to associate the same meaning and understanding of what “validation” means to the FDA.
Computer System Validation is the technical discipline that Life Science companies use to ensure
that each Information Technology application fulfills its intended purpose.
Validation: is Establishing the documented evidence which provides a high degree of assurance that a specific process will consistently produce a product of predetermined specifications and quality attributes
Computer System validation so important because its :
