A consistent approach in assessing and managing risk is crucial to successful quality management. MasterControl's risk management software system is an integrated solution to help companies identify and mitigate long term systemic risks by tracking and analyzing the recurrence of issues.
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Risk Management Challenges
MasterControl Risk Management Solutions
Disjointed Risk Systems:
A lack of standard risk management analysis methodologies and assessments results in enterprise-wide waste of time, money, and resources.
Integrated Risk System:
MasterControl brings together all risk management related documentation in a single location. MasterControl's risk management system has scheduled reporting and full search capabilities to provide insight and easy access into risk assessment and mitigation activities.
Inconsistent Risk Assessments:
In environments where risk assessments are performed but are not standardized, risk evaluations may vary from one assessor to the next. Whether an appropriate action is taken depends on the particular assessor, meaning that similar issues may end up being treated differently.
Standardized Risk Analysis Process:
MasterControl's risk management software insures that a single system is being used to collect and manage risk management related activities. The system guarantees that corporate risk tolerance thresholds are employed and followed for risk-related activities across the enterprise. When used in tandem with MasterControl Process™, standardized risk calculation tools and methodologies can also be implemented.
Disconnected Risk Processes:
The use of manual systems typically results in the creation of separate data repositories (e.g., risk analyses and corresponding CAPAs), making it difficult to track and record comprehensive documentation.
Connected Risk Management Processes:
MasterControl provides employees from different departments with a simple and efficient method for participating in risk assessment and mitigation activities. MasterControl's risk management software offers electronic workflows and signatures for execution, review, and approval of risk activities and documentation. Personnel can leverage a risk-based approach in multiple processes including CAPA, non-conforming material disposition, protocol development, supplier qualification activities, etc.
MasterControl Risk™ is a "one-stop shop" that unifies all risk-related activities and documentation in a single, centralized repository. The MasterControl risk management software system provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units, precluding reputation damage from recalls or regulatory action.
These examples demonstrate how MasterControl's risk management system helps companies efficiently manage consistent risk evaluation and mitigation processes:
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
In general terms, quality risk management is a set of systematized processes designed to help a manufacturer identify, assess and control the risks to the quality of a product across its life cycle.
Since risk management involves processes of identifying, addressing and eliminating potential failures, there is always some degree of managing risk involved in quality management. An integrated solution can unite risk and quality data within a centralized repository and ensure that all related processes stay connected.
Because quality processes rely on accurate risk analyses, a company's greatest risk and quality management challenge lies in its ability to effectively track, assess, prevent and correct problems. Maintaining an accurate overview of the risk landscape across product lines, business processes and business units is key.