In regulated environments, risk is generally understood as the combination of the probability of the occurrence of harm and the severity of that harm. In the life science industry, the U.S. FDA emphasizes risk management in relation to patient safety. As part of the risk management process that the FDA expects from the industry, life science companies must perform risk assessment, which entails an analysis of potential exposure to hazards. Many companies use risk assessment applications to make informed decisions in their operations and to fulfill their compliance requirements.
The FDA’s 2006 guidance called “Q9 Quality Risk Management” provides the pharmaceutical industry with a basic framework for the assessment, control, communication, and review of risks to the quality of a product. Under Q9, risk assessment consists of identification of hazards and the analysis and evaluation of risks associated with exposure to those risks. This guidance has influenced many risk assessment applications in the market today, which typically include tools for identifying hazards and evaluation of exposure to those hazards.
The FDA categorizes risk management activities into two areas: premarketing risk assessment and post-marketing risk assessment. The former refers to evaluation of risks during clinical development, including drug interaction risks and the potential for misadministration of drugs. For pharmaceutical companies and their CROs looking to buy a risk assessment application, make sure this type of premarketing risk assessment is covered by the application.
With regard post-marketing risk assessment, the FDA requires adverse event reporting to the agency, either as voluntary reporting by health professionals or as part of mandatory reporting. A robust risk assessment application should have the capability to manage adverse event reports and complaints from patients and health care providers.
Risk assessment figures prominently in GAMP 5, released in 2008, which offers guidance with regard validation of computer systems for pharmaceutical and biotech companies complying with GxP regulations.
Companies using risk management and risk assessment applications should take advantage of the framework and principles provided by GAMP 5 in validating their systems. GAMP 5 reinforces the fundamental risk management principles under the Q9 guidance, ICH Q10 (Pharmaceutical Quality System), and the FDA’s “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.”
GAMP 5 does not prescribe a method, but it offers a structure of good practices to ensure that your computer systems, including any risk management and risk assessment applications that you use, are compliant. Use GAMP 5 along with other industry guidelines, standards, and best practices to determine the best approach for your computer validation.
MasterControl quality and compliance software is widely used in life science, food and beverage, and other regulated industries that require effective risk management processes and need a robust risk assessment application as part of their quality management system (QMS).
MasterControl Risk: This risk management and risk assessment application provides a single platform for all risk management documentation, tasks, and activities for compliance purposes. It can serve as the centerpiece of your risk management efforts and will bring all stakeholders together for a holistic approach to compliance. It offers robust risk assessment application tools such as risk matrix, which can measure acceptable and unacceptable risks. MasterControl also offers robust analytics and reporting tools to help you evaluate risks and address them promptly.
MasterControl Clinical Suite: For pharmaceutical and medical device companies and CROs conducting clinical research, 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 with the help of risk management and risk assessment application tools.
MasterControl Documents: Life science, general manufacturers, and other regulated companies use this solution for compliance purposes and to increase their efficiency. MasterControl Documents can serve as the core of any quality management system, supporting all document- or forms-based processes such as CAPA, change control, training control, audit management, and risk management processes. It automates distribution/routing, review, follow-up, escalation, and approval of documents and forms. It includes risk assessment application tools such as analytics and reporting capability.
MasterControl Validation Services: Validation of computer systems is one of the most expensive and time-consuming aspect of automating or upgrading a QMS. MasterControl offers a full, front-to-back validation services and solutions—from planning to protocol creation and definition of the project, systems configuration, risk management through customized validation testing and reporting. With MasterControl, validation of your QMS, including any risk management and risk assessment applications, will be according to GAMP 5 principles.
For more information about risk assessment Applications offered by MasterControl, contact a MasterControl representative or by calling 800-942-4000.
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