As compliance environments become progressively more rigorous, a consistent approach to managing risk and anticipating quality issues is easiest to achieve with the implementation of an all-inclusive risk management solution. Automated risk management systems allow organizations to evaluate critical events more thoroughly and help them appropriately assess whether or not corrective measures are successful.
Every organization must able to accurately assess risk levels across product lines, business processes, and business units in real time. If the risk assessment systems in use are manual and (by default) disconnected it is nearly impossible to track and record comprehensive, up-to-date documentation. The company may even be generating several duplicate data repositories simultaneously. An automated risk management solution can bring all risk-related activities and documentation together under a single secure repository that can be accessed and leveraged across the enterprise.
With so many risk management solutions on the market, however, how do you know what you need and what can you do without? Here are a few key factors to consider:
If a risk management solution isn’t uniform and connected, it is useless. MasterControl’s risk management solution gives quality and regulatory teams a consistent means of performing dependable risk assessments. Engineering and manufacturing personnel can also use the MasterControl system to document and gather risk assessment/mitigation documentation in product design and process areas. MasterControl ensures that a risk assessment generated from any source throughout the enterprise (such as a bill of materials, risk-related document, etc.) is automatically connected to associated links within the risk management system.
MasterControl’s off-the-shelf functionality makes it particularly appealing, but the solution’s flexibility truly sets it apart from the field. Users have the ability to configure multiple risk types for evaluating different categories of operational risk. Risk assessments can be launched from virtually anywhere within the system in order to analyze dangers associated with any activity or procedure. Also, the risk management solution’s best practice process includes risk mitigation and reassessment capabilities. Because it has been designed with regulatory environments in mind, the system allows risk files to be routed for approval and electronically authorized in accordance with strict regulatory standards such as the FDA’s 21 CFR Part 11.
Another distinctive characteristic of MasterControl’s risk management solution is its incomparable reporting tools. The system’s analytics capabilities allow for in-depth analysis of risk assessments and other risk-related reports. The system also boasts scheduled reporting features and intelligent threshold rules that further entrench risk awareness throughout the enterprise.
Perhaps most importantly, the MasterControl risk management solution offers a single collection point for all risk-related activities that are relevant to a given project, process, or supplier. This is extremely beneficial in that it allows companies to effectively integrate risk assessments, documentation, and other risk management processes (FMEA, FTA, surveys, etc.).
For more information about risk management solutions offered by MasterControl, contact a MasterControl representative or by calling 800-942-4000.
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