Quality Risk Management Solutions

Quality Risk Management Software Solutions: Finding the Right Fit

As compliance environments become progressively more rigorous, a consistent approach to managing risk and anticipating quality issues is easiest to achieve with the implementation of an all-inclusive risk management solution. Automated quality risk management systems allow organizations to evaluate critical events more thoroughly and help them appropriately assess whether or not corrective measures are successful.

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Data Sheet: MasterControl Risk
White Paper: GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems
FAQ: Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance

Which Quality Risk Management Solution Is Right for You?

Every organization must able to accurately assess risk levels across product lines, business processes, and business units in real time. If the risk assessment systems in use are manual and (by default) disconnected, it is nearly impossible to track and record comprehensive, up-to-date documentation. The company may even be generating several duplicate data repositories simultaneously. An automated quality risk management solution can bring all risk-related activities and documentation together under a single secure repository that can be accessed and leveraged across the enterprise.

With so many risk management solutions on the market, however, how do you know what you need and what can you do without? Here are a few key factors to consider:

Uniformity:

Standardization and centralization are vital components of any enterprise-wide system. Any risk-oriented documentation that can have potentially negative organizational consequences must be contained in one secure and centrally accessible repository. Similarly, a lack of uniform risk analysis methodologies can only result in resource waste that will touch every department. A connected quality risk management solution loaded with useful features such as robust search and scheduled reporting capabilities can reduce wasted resources and provide ready access to risk assessment and mitigation documents and actions.
Full Management Oversight:

A quality risk management solution should be geared toward comprehensive and transparent supervision of risk activities. The core methodology of the system must be based on applying resources to the most risk-averse areas. Essentially, the risk management system has to provide the assurance that the organization is never able to exceed predetermined risk tolerances.
Risk Tolerance Thresholds:

A quality risk management solution must guarantee that corporate risk tolerance thresholds are followed for all risk-oriented activities throughout the organization. Calculation functionality and methodology can also be extremely useful.
Practical Functionality:

A quality risk management solution must be integrated and of use to all departments. It should give all personnel an unambiguous and convenient means of collaborating on risk management and mitigation tasks. Capabilities such as electronic workflows and signatures for document review, approval, and execution are just a couple of examples of the types of useful features that might come in handy.

MasterControl’s Quality Risk Management Solution Stands Apart from the Competition

If a risk management solution isn’t uniform and connected, it is useless. MasterControl’s quality risk management solution gives quality and regulatory teams a consistent means of performing dependable risk assessments. Engineering and manufacturing personnel can also use the MasterControl system to document and gather risk assessment/mitigation documentation in product design and process areas. MasterControl ensures that a risk assessment generated from any source throughout the enterprise (such as a bill of materials, risk-related document, etc.) is automatically connected to associated links within the risk management system.

MasterControl’s off-the-shelf functionality makes it particularly appealing, but the solution’s flexibility truly sets it apart from the field. Users have the ability to configure multiple risk types for evaluating different categories of operational risk. Risk assessments can be launched from virtually anywhere within the system in order to analyze dangers associated with any activity or procedure. Also, the risk management solution’s best practice process includes risk mitigation and reassessment capabilities. Because it has been designed with regulatory environments in mind, the system allows risk files to be routed for approval and electronically authorized in accordance with strict regulatory standards such as the FDA’s 21 CFR Part 11.

Another distinctive characteristic of MasterControl’s quality risk management software is its incomparable reporting tools. The system’s analytics capabilities allow for in-depth analysis of risk assessments and other risk-related reports. The system also boasts scheduled reporting features and intelligent threshold rules that further entrench risk awareness throughout the enterprise.

Perhaps most importantly, the MasterControl quality risk management solution offers a single collection point for all risk-related activities that are relevant to a given project, process, or supplier. This is extremely beneficial in that it allows companies to effectively integrate risk assessments, documentation, and other risk management processes (FMEA, FTA, surveys, etc.).