Quality Risk Management Database

How a Quality Risk Management Database Helps Regulated Companies Assess and Manage Risk

In regulated environments, successful quality management hinges upon having a consistent method for assessing and managing risk. The need for effective quality risk management can be found in numerous regulations and guidelines, such as ICH Q9 and ISO 14971. To ensure the safety and efficacy of its products, and to minimize its exposure to the many liabilities and penalties associated with non-compliance, a regulated organization should have a proactive risk management program and risk management database in place.

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