System validation is essential in pharmaceutical, biological and medical device manufacturing and distribution. In terms of environmental monitoring applications, a poorly executed validation is a risk to the quality of your monitoring software implementation.  Not only does validation prove that your monitoring system is fit for its intended use, it helps fulfill the ultimate goal of protecting consumers by ensuring product quality. Additionally, an inadequately qualified monitoring system will result in unwanted observations at inspection time and uncomfortable questions during customer audits.

To ensure that your implementation of the Vaisala viewLinc monitoring software complies with Good Manufacturing Practice (GMP), we recommend using the ISPE Good Automated Manufacturing Practice (GAMP) methodology for system validation as guide to ensure your monitoring system software performs as expected and helps you achieve compliance. GAMP provides a risk-based approach to the deployment and maintenance of GxP-compliant computerized systems using pragmatic and practical industry guidance to ensure your system performs effectively.

 

 

 

 

 

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