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What is Computerized Testing Systems | GxP Compliance Testing 2018

DoubleTree by Hilton Hotel San Diego Downtown

Thursday, January 18, 2018

 

 

Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. The assurance that systems perform as intended for their use reduces the overall lifecycle of implementing and operating the system and prevents delays to the use of the system that might have been caused by the need to make corrections to the system. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901363SEMINAR?wooeb-January-2018-SEO

 

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