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