Quality Risk Management Strategies for Computer Systems Validation
Sepúlveda Figueroa, Héctor
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Quality Risk Management is something that has been gaining attention in the regulated industry because it is listed as regulation in various regulatory agencies such as FDA, ICH, ISO, ISPE and other involved regulatory agencies, but all with the same goal of improving the and manufacturing quality of a product manufactured for the patient to be administered. From this part briefly assess how QRM strategy works by Good Manufacturing Practices, and regulatory requirements and associated guidance documents, making certain methodology on QRM to CSV is presented. We must take into account that there is no fixed for all situations that arise in a given time methodology. The competent professional is the best person to select which type of methodology will do the QRM to be adjusted to the problem presented in the areas related to computer systems. In this article we present how we can achieve risk reduction through QRM in CSV. Key Terms - Computer Systems Validation, Quality Risk Management, Risk Reduction, Strategies.