Regulatory Requirements as the Basis of Risk Management Applications
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.
Quality Management System and Risk Management Applications
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.
- Document Control: SOPs, policies, and procedures are meant to instruct employees how to perform tasks or conduct certain operations. In regulated environments, these documents must be controlled because they have direct impact on product quality and safety. The assumption is that following these documents (especially SOPs) will help ensure uniformity, which in turn help ensure quality. Most risk management applications provide tools for the document control process.
- Training Control: Employees must be qualified to perform their jobs. In addition, they must be trained on specific tasks and documents (SOPs, policies, etc.). In regulated environments, the training process must be controlled and documented as part of overall compliance. Effective risk management applications will be able to assess the impact of training completion on compliance.
- Change Control: Change is essential for continuous product improvement. In terms of risk management, any change in processes, design, equipment, raw materials, etc., must be documented and evaluated to make sure that the change has no impact on quality and safety. A risk management application typically makes sure that the change does not inadvertently create new risks.
- Corrective Action and Preventative Action: Regulations (e.g., FDA's 21 CFR Part 820), guidances (e.g., ICH E6 GCP Consolidated Guidance), and standards (e.g., ISO 13485) generally require that when quality issues arise, CAPA should be implementedâ€”including investigation of how widespread the problems are, correction of the problems, and efforts to help prevent their reoccurrence.
- Risk Management: While risk management should be part of each quality process, robust risk management applications also provide tools specially designed for this purpose and consolidate different risk management components from individual quality processes for a holistic approach.
What Makes MasterControl Different From Other Risk Management Applications
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:
- User-Friendly Features: Users can manage risks by project and launch a risk assessment for every project. With MasterControl, a user can easily view and report risk assessments for each project, as well as their statuses.
- Robust Reporting Tools: MasterControl's risk management application features analytics and reporting tools that analyze risk files and risk assessments. Users can choose preconfigured reports or customize them to address specific needs. Reports can be scheduled regularly for increased oversight.
- Risk Matrix: MasterControl's risk matrix is designed so that high risks will require users to perform mitigating action. It can measure acceptable and unacceptable risks. For example, in managing clinical research, the risk matrix can help assess the risks of certain clinical sites, including facilities, equipment, support staff qualifications, etc.
- Various Integration Points: Unlike other risk management applications, MasterControl allows users to launch risk assessments from different places within the system. Keywords are used to launch them from any MasterControl Process form (e.g., CAPA, supplier, change control, etc.).
For More Details on Risk Management Applications
To learn more about MasterControl's risk mananegment applications, contact MasterControl representative.