Quality

Risk Assessment Software

Risk Assessment Software Systems Automate Risk Controls and Facilitate Quality Compliance

MasterControl's Risk Assessment Software Systems are designed by industry practitioner for automating the Risk Assessment process in any organization. A Risk Assessment system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated Risk Assessment system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Data Sheet: MasterControl Risk
FAQ: Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance
Kit: 11 Free Resources to Boost Your FDA Readiness
White Paper: GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems White Paper: Noncompliance to FDA Quality Standards: What's the Risk to Executives? White Paper: Cannon Quality Group: Risk Management and Connected Risk
Industry Brief: Simplify CAPA in 7 Steps

Managing Risk with Automated Risk Assessment Software Systems

Every organization of every size wants an accurate vision of its risk landscape across product lines, business processes, and business units. When manual, disconnected risk systems are in place it becomes difficult to track and record comprehensive documentation and multiple separate data repositories are often generated. An automated risk assessment software system can provide a "one-stop shop" that unites all risk-related activities and documentation within a secure central repository that is accessible and utilized enterprise-wide.

When it comes time to shop for a risk assessment software system, what functionality should you be looking for - and what extra bells and whistles can you do without? Take the following factors into account:

Standardization and centralization are key components of risk assessment software. All-risk related documentation should be contained in a single secure repository. Just as importantly, a lack of standard risk analysis methodologies and assessments will result in wasted resources throughout the enterprise. A feature-rich risk assessment system with full search and scheduled reporting capabilities can help avoid such severed connections and waste while providing trouble-free access to risk assessment and mitigation activities and documentation.
The risk assessment solution should guarantee that corporate risk tolerance thresholds are followed for all risk-oriented activities throughout the organization. If available, calculation tools and methodologies can also be extremely useful.
An effective risk system should give employees from different departments a clear-cut and efficient means of participating in risk assessment and mitigation activities. Tools like electronic workflows and signatures for execution, review, and approval of documentation are examples of the types of useful elements to look for in a high-quality risk assessment software system.

What Sets MasterControl's Risk Assessment Software System Apart?

If a risk assessment system isn't uniform, it has no real purpose. MasterControl's risk assessment software gives quality and regulatory groups a standardized method to perform reliable risk assessments. Employees in engineering and manufacturing departments can also use MasterControl to easily document and store risk assessment/mitigation documentation in product design and process areas. The MasterControl system ensures that risk assessments launched via an item from anywhere throughout the enterprise (such as a document, process, project, bill of materials, etc.) will be automatically connected to the appropriately related links within the MasterControl software system.

The out-of-the-box functionality of the MasterControl software is robust, but the system's flexibility makes it truly unique. System users can configure multiple risk types for evaluating different categories of operational risk. Risk assessments can be launched from virtually anywhere within the MasterControl risk assessment software in order to analyze hazards associated with any process or activity. MasterControl's best practice process also includes risk mitigation and reassessment.

Other Benefits of MasterControl's Risk Assessment Software System

The importance of comprehensive management oversight is another core component of the MasterControl risk assessment software system. The solution's standard methodology simplifies the application of resources in the most risk-prone areas. To put it simply, the focus of the MasterControl software is to ensure that organizational risk tolerances are not exceeded.

Powerful reporting tools are also a key distinguishing feature of the MasterControl software. The solution's analytics reports allow for deep analysis of risk assessments and other risk-related files. The software scheduled reporting feature and intelligent threshold rules also increase risk awareness throughout the organization.

When it comes to efficient, secure, and compliant risk file management, the MasterControl risk assessment software system is unparalleled. The system offers a single collection point for all risk-related activities pertinent to a given project, process, or supplier to effectively integrate risk assessments, documentation, and other risk management processes (FMEA, FTA, surveys, etc.). In addition, risk files may be routed for approval and electronically authorized in accordance with rigid regulatory standards such as 21 CFR Part 11.

More Information about Risk Assessment Software Systems

For more information about risk assessment software systems offered by MasterControl, contact a MasterControl representative or by calling 800-942-4000.