Quality Risk Software


Online Risk Management

MasterControl's Online Risk Management Solution Helps Regulated Businesses Identify and Reduce Risk

As the FDA, EMA, and other regulatory bodies worldwide continue their intense scrutiny of quality professionals, risk management is becoming the strongest, most comprehensive way for regulated organizations to benchmark compliance in their quality processes. However, risk management can be confusing for those who are unfamiliar its policies. It can also be expensive to set up and manage risk management software throughout an organization. MasterControl provides an easy-to-use online risk management software solution that guides regulated companies through every phase of the risk management process.

MasterControl Risk™

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MasterControl's software can be accessed quickly and securely through your company's existing web browser. There are options to host the server at your company or have us host it for you so there is no need to manage additional server infrastructure. If you need a robust solution that will enable you to identify, document, treat, and monitor risk - MasterControl's online risk management solution may be right for you.

On-Premise vs. Online Risk Management

Mounting compliance pressures, supply chain complexity, and consumer demand for newer, higher quality products has made it difficult for regulated organizations to stay competitive. As a matter of survival, many organizations are reorganizing their approach to risk and applying risk-based methods, such as risk assessment and risk management, to their business processes to keep up with today's tumultuous business landscape. While this can be quite a challenge, an online risk management solution can simplify the process significantly. What's more, it can do it for a fraction of the start-up cost of a traditional premise-based risk solution.

While there are many benefits to be gained by implementing an automated on-premise risk management program throughout your organization, including the amount of money you'll save in the long run due to fewer penalties and increased efficiency, there is no denying that the initial capital outlay can be cost prohibitive for some organizations. That is why MasterControl offers both a premise-based and an online risk management solution.

Deployed over the Internet, for a low quarterly fee, MasterControl's online or cloud-based solution allows you to quickly implement and enjoy the same powerful MasterControl system leveraged by hundreds of regulated companies worldwide - not a "watered-down" or "lite" version - to achieve your compliance and business goals. If your company is under pressure to comply with stringent regulatory requirements but also concerned about the large up-front infrastructure costs and resource requirements associated with traditional on-premise software ownership, MasterControl's online risk management solution may be just what you need.

Strengthen Your Compliance Program with MasterControl's Online Risk Management Solution

MasterControl Risk™ is a web-based software solution that unifies all risk-related activities and documentation in one centralized repository. Part of the MasterControl suite of quality management products, MasterControl Risk is offered as both an on-premise and online risk management solution, and is designed to integrate risk management with other critical quality processes, including document management, audit management, CAPA event management, and supplier management. MasterControl's risk solution offers compliance professionals "one-stop shopping" for all risk-related practices throughout an organization. Consider the following features:

  • Superior Risk Assessment Capabilities: Proper assessment of risk helps to drive decision making in a quality management system. MasterControl's online risk management solution allows users to configure multiple risk types for evaluating different categories of operational risk. From anywhere within the MasterControl system, users can launch sophisticated risk assessment tools, which will enable them to analyze the hazards associated with any process or activity. Once defined, users can prioritize adverse events and define the action to be taken. Excessive corrective actions or "death by CAPA' can cause a bottleneck in a quality management system. The risk assessment tools provided in MasterControl's risk management software can help filter events and minimize corrective actions.
  • Advanced Reporting Tools: MasterControl Risk, the online risk management solution offered as part of our quality management suite of products, features advanced analytics and reporting capabilities, which allow for the analysis of risk files and risk assessments. The solution's scheduled reporting capability and intelligent threshold rules increase management awareness and provide assurance that corporate risk tolerance thresholds are being followed for all activities that are related to risk.
  • Compliant with 21 CFR Part 11: MasterControl's online risk management software provides a single collection point for all risk-related activities that are pertinent to a particular project, process, or supplier. These activities can include risk assessments, documentation, and other processes related to risk management, such as FMEA, FTA, surveys, etc. Risk files may be routed for approval and electronically authorized in accordance with 21 CFR Part 11. These features are critical for regulated organizations that are hoping to achieve compliance with their online risk management program.
  • One Solution Simplifies Ease of Doing Business: By automating all paper-based or hybrid risk management processes in a single online risk management repository, your organization is provided with a comprehensive and precise picture of its entire risk landscape - across product lines, business processes, and business units. The solution offers "one-stop shopping" to quality and compliance professionals in need of quick access to full search capabilities and electronic workflows and signatures for the execution, review, and approval of all risk-related activities and documentation. MasterControl Risk insures that organizational risk tolerance is not exceeded because the online risk management software's standard methodology simplifies the application of resources in the most risk-prone areas.

Online Risk Management Offers Many Additional Benefits

Whether you decided to go with a premise-based or a subscription-based online risk management system ultimately depends upon the specific needs and goals of your business as there are advantages to both. As you begin to explore what's possible in a subscription or cloud-based environment, you should start examining some of the fundamental questions about the role technology plays in your business. While the opportunity to avoid the large initial investment in software licenses and infrastructure costs is one of the biggest advantages of opting for a cloud-based risk solution, it is far from the only one. MasterControl's subscription-based online risk management solution offers the following additional benefits:

  • Reduced Overhead: MasterControl's online risk management solution simplifies IT managment. You have the option of hosting the application with us to handle the IT administration for you, so there's no need to invest in additional infrastructure. In addition, software installation, configuration, and connectivity policies and procedures are provided by MasterControl experts who understand your compliance concerns. Finally, MasterControl monitors hardware and software environments for performance, connectivity, and uptime; this frees up valuable IT resources.
  • Fast, Easy Implementation and Scalability: MasterControl's online risk management solutions offers a scalable infrastructure, which makes it easy to add more users and/or increase storage as your business needs grow and/or change. Since our hosted solution is delivered over the Internet, deployment is fast and easy. You'll be able to start using the system, and improving your compliance efforts, almost immediately. With the exception of scheduled systems maintenance periods, MasterControl commits to maintaining a minimum system availability of 99.95% during primary hours of operation.
  • Increased Cost-Efficiency and Productivity: Our online risk management solution allows you to upgrade to the electronic quality management system you want - and need - instead of sticking with an inadequate and inefficient manual system. 100% Web-based access means your information is available to all of your employees from anywhere, increasing collaboration and productivity. Predictable subscription-based payments based on the number of users accessing the service means there are no surprises or unforeseen IT expense increases to contend with, which makes budgeting easier. Best of all, we make sure you have the most up-to-date version of the software relieving your staff from the burden on having to maintain your online risk management solution.

For More Details on Online Risk Management

To learn more about MasterControl's hosted or on-premise online risk management, please contact MasterControl representative.

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