The process of manufacturing a product is filled with risks, but especially in regulated environments, where risks are double-edged: business and compliance. Regulatory bodies incorporate the concept of risk management in regulations and guidances to help manufacturers mitigate risk. Risk analysis is a key part of risk management and risk management applications are designed to make it easier to manage risks.
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The U.S. Food and Drug Administration’s 2003 initiative called “cGMPs for the 21st Century—A Risk-Based Approach” emphasizes the importance of scientific risk-based management to ensure product quality. Risk analysis is key to this initiative, greatly influencing risk analysis applications today.
The FDA also released a guidance in 2006 called “Q9 Quality Risk Management” to provide the industry with a framework for the assessment, control, communication, and review of risks to the quality of a product. FDA-regulated companies looking to use a risk analysis application should make sure that the software covers all those key areas.
The Q9 guidance identifies the following as key components of the risk management process: risk identification, risk analysis, risk evaluation, risk reduction, risk acceptance, and risk review. These are key elements that should be addressed in a robust risk analysis application. For the pharmaceutical industry, the FDA also requires a “risk evaluation and mitigation strategy” (REMS) as part of the submissions during the approval process for a new medicine. Sometimes REMS may be required for an approved drug when new safety information is available. In terms of REMS submission, a sponsor or a CRO could greatly benefit from a risk analysis application.
ISO 14971, a quality standard on risk management for medical device firms, requires manufacturers to perform a risk analysis for every medical device. Section 4 specifically requires manufacturers to identify “hazards” for each medical device and also estimating the risk for each hazardous situation.
In evaluating risk analysis applications, medical device firms should choose one that will facilitate documentation of the intended use of the product, including product features that could affect safety. Choose a risk analysis application that will streamline the process of identifying risks, estimating the likelihood of such risks or hazardous situations, and evaluating the risks for each hazardous situation.
MasterControl is an end-to-end quality and compliance software that addresses the risk management requirements of regulated companies. It offers robust risk analysis application tools in the following solutions:
To get more detailed information on risk analysis applications, feel free to contact MasterControl representative.