(Cybermetrics: Phoenix) -- The Food and Drug Administration (FDA) defines validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.”

Software validation, as it applies to GAGEtrak gauge calibration software, involves making sure that GAGEtrak functions as designed. Software validation involves both assuring that the software itself works properly and that it works under the purchaser’s actual conditions.

FDA Validation good manufacturing practices (GMP) require that purchasers of vendor-supplied software are responsible for performing the software validation under its normal operating conditions and maintaining international standards.

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