Risk Management Database

How a Risk Management Database Helps Regulated Companies Assess and Manage Risk

In regulated environments, successful quality management hinges upon having a consistent method for assessing and managing risk. The need for effective risk management can be found in numerous regulations and guidelines, such as ICH Q9 and ISO 14971. To ensure the safety and efficacy of its products, and to minimize its exposure to the many liabilities and penalties associated with non-compliance, a regulated organization should have a proactive risk management program and risk management database in place.

The Benefits of a Having a Risk Management Database

While some regulated organizations lack a formal, comprehensive process for properly identifying, analyzing, evaluating, and controlling risk, all regulated organizations are likely to have some basic processes in place to address and respond to operational risks smoothly and effectively.

For companies that do not have a formal risk management process, a simple risk management database may be a beneficial tool. The size of the company, nature of its business, and the regulations and standards it is required to comply with are some of the factors that determine whether the tool can be relatively straightforward (for example, a spreadsheet) or requires more sophistication (for example, an electronic system). Risk management has many connotations depending upon its audience (i.e., a drug manufacturer as opposed to a medical device maker). Whether the tool is a spreadsheet or an electronic system, it is crucial that the risk management database be in accordance with the regulations and standards applicable to the particular company.

For example, ISO 14971 has become the "de facto" global standard for risk management for medical device companies. The standard, of which the latest revision was published in 2007, specifies a process for a manufacturer to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the lifecycle of a medical device. In this context, a medical device manufacturer creating a risk management database should consider how the database would help not only in estimating and evaluating the quality problems that could expose the company to harmful risk, but also how it can help in reducing, controlling, and monitoring that risk moving forward.

Establishing a Proactive Risk Management Database with MasterControl

MasterControl Risk™ is a web-based software solution that is easy-to-use, easy-to-implement web-based and unifies all risk-related activities and documentation in a single, centralized repository. The solution is designed to integrate the risk management process with other quality processes, such as document control, audit management, and supplier management. MasterControl's "one-stop shop" risk solution can serve as framework for a risk management database and a platform for all risk-related practices throughout an organization. Consider the following features:

• Risk Assessment Capabilities: MasterControl allows users to configure multiple risk types for evaluating different categories of operational risk. Risk assessments can be launched from anywhere within the MasterControl system to analyze hazards associated with any process or activity. MasterControl's best practice process also includes risk mitigation and reassessment, essential components of any risk management database.
• Advanced Reporting Tools: MasterControl's advanced analytics and reporting capabilities allow for the analysis of risk files and risk assessments. The system's scheduled reporting capability increases management awareness and provides assurance that corporate risk tolerance thresholds are being followed for all risk-related activities.
• 21 CFR Part 11-Compliant: MasterControl provides time-stamped audit trail, electronic signatures, and reporting capabilities designed to be Part-11 compliant. Risk files may be routed for approval and electronically authorized in accordance with 21 CFR Part 11. These features are critical for FDA-regulated companies that are establishing a risk management database.
• One-Stop Shopping: By automating all paper-based or hybrid risk management processes in a centralized repository, MasterControl's "one-stop shop" solution can provide a regulated organization with a complete, accurate picture of its entire risk landscape-across product lines, business processes, and business units. MasterControl Risk has been specifically designed for professionals who need quick access to full search capabilities and electronic workflows and signatures for the execution, review, and approval of all risk-related activities and documentation typically included in a risk management database.

Electronic Risk Management Database Offers Many Additional Benefits

Creating a proactive risk management database with MasterControl is easier and faster than creating one manually. In addition, MasterControl offers the following additional benefits:

• Uniformity: MasterControl provides regulatory and quality departments with uniform methods for conducting consistent risk analyses. Using MasterControl Risk, engineering and manufacturing personnel can easily document and store risk mitigation activities in product and process design, which greatly increases efficiency.
• Integrated Processes: The risk management process, including the risk management database, should be part of a holistic quality management system. With MasterControl, risk management can be integrated with other critical quality processes such as audit management, document management, and supplier management. For companies that use other electronic systems, MasterControl can be seamlessly integrated with document repositories and enterprise applications, such as ERP, without the need for expensive custom coding and without changing critical business process the organization spent years implementing.
• Compliant System: In a regulated environment, a risk management database, just like the risk management process itself, must be compliant. MasterControl helps regulated organization's document and demonstrate an effective risk management program and achieve compliance during audits and inspections.

For Additional Information on MasterControl's Risk Management Database

For more information about MasterControl's risk management database software, contact a MasterControl representative or by calling 800-942-4000.