Qx

Quality

Risk Management Software Applications

Risk management software applications are key to compliance.

The term “risk” has an increasingly large presence in regulations and standards. The importance of risk management and risk-based thinking are tied back to safety and quality. From ISO 9001 to ICH Q9 to GAMP, risk management is important in every industry. Using risk management applications standardizes processes and improves compliance.

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Better risk management is in demand everywhere.

01

Medical Device Companies

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ISO 14971 is a standard used worldwide to handle risk in medical devices. The standard requires companies to develop a risk management framework to identify and control risk.

02

Pharmaceutical Companies

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The U.S. Food and Drug Administration (FDA) developed “Guidance for Industry: Q9 Quality Risk Management” to help the pharmaceutical industry deal with risk. The guidance explains risk and how quality management principles can help mitigate and control it.

03

Computer System Validation

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In every industry, digital systems are becoming the norm. Validating these systems is simpler with risk taken into consideration. The GAMP 5 guidelines encourage a risk-based approach to validation to cut time and cost.

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Control and Mitigate Risk

Risk can’t be eliminated. But it can be mitigated and controlled. With the right risk management tools, regulated companies can turn risks into opportunities.

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Risk-Based Validation

The Validation Excellence Tool (VxT) is a unique, patented risk-based validation tool. It helps users identify and manage risk in their software validation. It also cuts time and cost of validation, in some cases letting users validate in less than an hour.

The best tool for your risk management.

Learn more about how MasterControl Risk can help your organization.

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