Using Risk Analysis Applications in the FDA Environment
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.
Using Risk Analysis Applications to Address ISO 14971
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 Provides Risk Analysis Applications for Regulated Companies
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:
MasterControl Risk Management:
This solution is ideal for all types of companies in regulated environments. It standardizes assessment and management of risks for compliance purposes. It provides a centralized location for all risk management-related documents. This risk analysis application allows users to launch risk assessments from different places within the system. Users can utilize keywords to launch a risk assessment from any MasterControl Process form (e.g., CAPA, supplier, change control, etc.). It includes risk analysis application tools such as a risk matrix, which measures acceptable and unacceptable risks.
MasterControl Clinical Suite:
For pharmaceutical and medical device companies and CROs, this solution streamlines and manages all documents, tasks, processes, training, and audits throughout the clinical trial. It manages risk throughout the life of a clinical trial using reporting and analytics and other risk analysis application tools.
This solution can serve as the centerpiece of a quality management system, supporting all other document- or forms-based processes such as CAPA, change control, training control, and audit management, among others. It automates distribution/routing, review, follow-up, escalation, and approval of documents and forms. It includes risk analysis application tools such as analytics and reporting capability.
With MasterControl, the entire process for routing, escalation, and approval of CAPAs can be automated and connected to other quality processes, including any application for risk analysis. MasterControl can track quality incidents that can escalate into a CAPA, strengthening the risk management process and supplementing any risk analysis application in use.
For More Information on MasterControl Risk Analysis Applications
To get more detailed information on risk analysis applications, feel free to contact MasterControl representative.