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CyberMetrics Corp.

FDA Compliance

Product News: GAGEtrak Validation Guide

For when the FDA says it’s up to you but you haven’t a clue.

Published: Friday, December 18, 2009 - 11:05

(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.

To assist users in accomplishing validation, CyberMetrics validates GAGEtrak gauge calibration software before its original release and continues to validate it prior to each subsequent update release to ensure gauge standards and calibration compliance with QS-9000 and ISO 9001 standards alongside 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 users in validating software package and also provides help in:

  • Testing the software’s functionality
  • Preparing standard operating procedures (SOP) for this software
  • Training the users of the software
  • Documenting the formal validation report

 

For more information on the GAGEtrak Validation Guide, visit online at http://gagetrak.com.

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CyberMetrics Corp.’s picture

CyberMetrics Corp.

Founded in 1988, CyberMetrics Corp. develops, markets, and supports high-quality, open-standards software solutions for calibration and quality management, preventive maintenance, and supplier quality assurance that are affordable, scalable, and easy to implement, manage, and use. More than 12,000 facilities worldwide use CyberMetrics’ products to manage their assets, calibrations, preventive maintenance and supplier quality while maintaining standards compliance and reducing costs. CyberMetrics provides extensive support and maintenance services and backs every solution with a money-back guarantee.