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The 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 gage 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 GMPs require that purchasers of vendor-supplied software are responsible for performing the software validation under its normal operating conditions and maintaining international standards.
To assist you in accomplishing this validation, CyberMetrics validates GAGEtrak gage calibration software before its original release and continues to validate it prior to each subsequent update release to ensure gage standards and calibration compliance with QS 9000 and ISO 9000 standards along side the FDA regulations.
The Validation Guide's User's Manual serves as the basis by which the software is validated for international standards. A sample validation database is included in the GAGEtrak Validation Guide to further assist you in validating your software package and also provides help in:
- Testing the software's functionality.
- Preparing your standard operating procedures (SOPs) for this software.
- Training the users of the software.
- Documenting the formal validation report.
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