The term "risk" as defined in ICH Q9 Guidance refers to the combination of the probability of occurrence of harm and the severity of that harm. While risk is practically impossible to avoid, one can mitigate its occurrence. In life science and other regulated industries, the ultimate risk that must be continuously managed pertains to the safety of patients and consumers. Guidances such as ICH Q9 (for pharmaceutical companies) and other regulations and standards provide risk management principles and tools. Risk management applications are available in the market to help regulated companies comply with regulations.
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Risk management is as broad as the variety of products and therapies available in the global market that are currently regulated. Its purpose can range from protection of intellectual property (patents) to mitigation of product liability to ensuring patient safety. The good news is that there is likely to be a risk management application already in the market for any and all of these things.
In the pharmaceutical industry, companies are increasingly turning to risk management applications to comply with international guidances such as ICH Q9 Quality Risk Management. This document provides specific guidelines on the establishment of a quality management system (QMS), as well as the use of tools and processes for the purpose of ensuring product quality and safety. Guidances from the U.S. Food and Drug Administration (FDA) such as the "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring" help sponsors conduct safe clinical research and at the same time ensure the integrity of the clinical trial.
In the field of medical device, manufacturers under the jurisdiction of the FDA or those selling their products in the European Union must adhere to ISO 14791:2007, which specifies a process for identifying risks in all stages of a life cycle of a medical device, controlling those risks, and monitoring the effectiveness of the controls. While manufacturers can conduct risk management using home-grown systems, many are taking advantage of risk management applications specially developed for this purpose.
In regulated environments, risk management is considered an essential component of a quality management system (QMS). Companies are required to establish a QMS as a means for ensuring, evaluating, and documenting product quality and safety. It also serves as a structure for assessing and managing risks. Risk management applications are generally based on the concept that risk management should be embedded within the QMS.
The following are some of the key elements of a QMS. An effective risk management application should cover these elements.
MasterControl Risk provides a single platform for all risk management tools, documentation, tasks, and activities for compliance purposes and for the accomplishment of business goals. Here are some features that set MasterControl Risk apart from other risk management applications:
To learn more about MasterControl's risk mananegment applications, contact MasterControl representative.