What is AssurX Validation Management Services?
With the FDA’s shift to Computer Software Assurance (CSA), AssurX has developed a risk based validation model that provides customized validation services based on a critical thinking approach that supports the GAMP 5 Model. CSA encourages automated testing as well as the acceptable use of vendor documentation and formal testing of the installed software. The new approach reduces the amount of redundant documentation and validation activities and increases the focus on ensuring the software works as intended in the installed environment.
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