Quality Risk Software


Enterprise Risk Management Software Systems

Enterprise Risk Management Software Systems and Its Role in Regulated Industries

Risk management is now a core requirement for all industries regulated by the FDA and other global regulatory agencies. The requirements vary, but proactive enterprise risk management systems help regulated companies protect themselves from a host of liabilities and possible enforcement action. Well executed risk management programs can even be a source of competitive advantage.

MasterControl Risk™

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MasterControl's enterprise risk management software is designed to automate the entire risk process, and to ease the major issues and challenges associated with managing risk. Moreover, a risk management solution from MasterControl allows regulated companies to connect their risk management process with other quality processes, such as CAPA management and audit management, to control their organizational risk in an enterprise-wide fashion.

Enterprise Risk Management Software Helps Regulated Companies Reduce Enterprise Risk and Add Organizational Value

As the regulatory environment continues to shift toward a more risk-based approach to quality management, more and more regulated companies are relying on enterprise risk management software systems to develop strategies to minimize risks related to products, processes, and services. An enterprise risk management solution may be called upon to address a number of challenges related to assessing and managing risk such as how to identify the most risk prone areas, how to define risk categories, and how to document and store risk mitigation activities in product and process design. In a large or growing company, it is almost impossible to manage risk and demonstrate compliance without an integrated risk software solution. Of course, the benefits of effective risk management go far beyond avoiding compliance violations. Well managed compliance planning can add real value to the organization, which is why so many best-in-class life sciences companies view it as a strategic imperative.

MasterControl's enterprise risk management software, MasterControl Risk™, is robust and flexible enough to manage all types of risk that can affect the safety and reliability of products and directly impact brand equity. It enables organizations to identify measure, categorize, monitor, and manage all of their risk-related activities in a single repository, giving the organization a complete and accurate picture of its entire risk landscape. This comprehensive view is a key component of the most effective enterprise risk management systems, and is essential for any company that hopes to remain compliant, profitable, and competitive in today's evolving global market.

Tackle the Most Critical Risk Management Challenges with MasterControl's Enterprise Risk Management Software

  • Systems that are disjointed: Huge amounts of time, money, and resources are wasted in companies that lack a standard method of analyzing and assessing risk. Organizational silos and outdated documentation systems are preventing effective integration of risk management structures and responsibilities. This is a major challenge as integration is the key to achieving risk mastery.
  • MasterControl Solution: MasterControl is an integrated solution. It connects users, data, and processes under a centralized system, so it vastly improves communication, oversight, and visibility across the entire organization. And because MasterControl's enterprise risk management software is Web-based, third-party suppliers and off-site employees are able to participate in key risk decision-making processes from virtually anywhere, at any time.
  • Inconsistency in Assessing Risk: It's vital to have a mechanism in place to standardize risk assessments so that risk evaluations do not vary from one assessor to the next. Otherwise, similar issues may end up being treated entirely differently. MasterControl Solution: MasterControl streamlines the entire risk management process. Because the system was designed based on the best practices of the most effective enterprise risk management systems, it guarantees that corporate risk tolerance thresholds are employed and followed for all risk-related activities across the enterprise.
  • Processes that are disconnected: When separate data repositories are created, as is often the case in manual systems, documentation changes often fall through the cracks. An integrated method for tacking and recording comprehensive documentation across all processes is needed. MasterControl Solution: MasterControl's enterprise risk management software seamlessly connects all documentation relating to the company's risk assessment and mitigation activities. The solution offers electronic workflows and signatures for execution, review, and approval of risk activities and documentation. Multiple processes, such as corrective action preventive action management, supplier qualification, and non-conforming material disposition, can be integrated to optimize efficacy and efficiency.

Features That Set MasterControl's Enterprise Risk Management Software Apart

The marketplace reality is that effective management of compliance risks is necessary for an organization's survival and success, and nowhere is this more true than in the life sciences industry where there is zero tolerance for risk. MasterControl's enterprise risk management software provides a single platform for all risk management tools, data, and activities to not only drive an organization's compliance goals, but also its business objectives. Here are some features that make MasterControl Risk one of the industry's premier enterprise risk software systems:

  • Easy-to-use Features: Employee adaption is typically high with MasterControl largely due to the software's user friendly features. Users can manage risks by project and launch risk assessments for each individual project. Users can easily view and report risk assessments for each project as well.
  • Risk File Management: MasterControl simplifies the complexity of risk by providing users with a single collection point for all risk-centric activities and documentation pertinent to a given project, process. In addition, risk files may be routed for approval and electronically authorized in accordance with 21 CFR Part 11.
  • Robust Analytics and Reporting Tools: MasterControl's enterprise risk management software offers its users robust analytics and reporting features that analyze risk assessments, files, etc. The solution gives users the option of selecting preconfigured reports or creating custom reports to address specific organization needs. In addition, the solution allows for reports to be scheduled regularly for more effective enterprise-wide oversight.
  • Risk Matrix: MasterControl's risk matrix is designed to measure acceptable and unacceptable risks, and to help users quickly recognize the high risks that require mitigating action. A very useful tool, and one that should be included in all enterprise risk management software systems, MasterControl's risk matrix helps organizations avoid wasting time, money, and resources on infrequent or low impacting risks.
  • Best-Practice Form: MasterControl's best-practice form is a handy tool for risk management that prompts users to compile and track relevant data for assessing risks.
  • Risk Assessment Tools: Unlike other enterprise risk management software 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, for example, change control, supplier, etc. Risk assessments launched from an item in any MasterControl software module are then linked automatically to related InfoCards within the MasterControl system.
  • Connectivity and Collaboration: By integrating all of the different quality management processes that could impact product quality and increase risk, MasterControl makes it easier for different departments and geographically dispersed employees to participate in risk management activities. Risk-based planning is most effective when done in a collaborative environment where all of the organization's monitoring groups are free to exchange and refine ideas. Enterprise risk management systems that do not promote this level of connectivity and collaboration leave an organization more vulnerable to risk and therefore liabilities and sanctions.

For More Information on MasterControl's Enterprise Risk Management Software

To learn more about MasterControl's enterprise risk management software, contact MasterControl representative.

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