Quality

Excelling at Pharma Risk Management

An integrated software solution gives you a smart and consistent approach to assessing and managing risk. Modern pharma risk management tools eliminate delays and avoid added costs of product releases.

Pharmaceutical companies operate in a highly regulated environment. Compliance depends on proper risk management. Companies should deploy advanced pharma risk management tools to unify all risk-related activities, enabling staff from multiple departments to collaborate in risk assessment and mitigation. Automatically track and trace risks. Effectively analyze trends to ensure you can correctly rank and resolve issues.

Free Resources

MasterControl Risk

Frequently Asked Questions (FAQ) About Pharma Risk Management

What are the five steps in a risk management process?

MasterControl’s Risk: digitized pharma risk management tools and solutions.

List questions about the risks involved in the process or system.

Identify hazards associated with the risk.

Use both current and historic data to analyze the risk and determine if it is above the acceptable level.

Determine the likelihood and level of impact of the risk.

Document the risk and inform all relevant stakeholders.

What is good risk management in the pharma industry?

Good risk management uses a systematic, data-driven approach to identify and mitigate risks to avoid costly delays and product recalls. A risk management strategy includes a planned set of controls designed to ensure process performance and product quality. Staff should be able to share data and collaborate in risk assessment and mitigation.

How can you reduce risk?

Employ risk-based thinking. Set up a system for effectively aligning people, processes, and technology. Defects or discrepancies commonly go undiscovered until later in the production process or postmarket. Pharma risk management needs to start earlier and be performed in greater detail and at every stage of the product’s life cycle.

Quality Risk Management Resources

Select the free quality risk management resources you’re interested in downloading.

Ultimate Guide: The Ultimate Guide to Pharmaceutical Quality Management
White Paper: 6 Must-Haves for a Quality Management System (QMS)
Case Study: Fagron Case Study
Industry Brief: Simplify CAPA in 7 Steps
Trend Brief: 2024 Pharmaceutical Industry Trends

Identify and Resolve All Risks

Quality risk management involves designing processes to monitor, control, review, and communicate risks to ensure product quality and safety.

Risks can be discovered at any stage of drug production and manufacturing.

MasterControl Quality Excellence – Digitized quality management solution ensures quality across the product’s life cycle.
Applying pharma risk management processes later could cause costly delays.

MasterControl Equipment Calibration – Automates equipment calibration processes, helping manufacturers prevent out-of-specification (OOS) risks and ensure audit readiness.
Complex and undocumented quality risk management leads to undetected risks.

MasterControl Risk – Gives you a complete view of your enterprise risk landscape.
Lack of training leads to quality issues slipping through the cracks.

MasterControl Training – Streamlines training tasks, including routing, tracking, and follow-up.
Lack of integrated quality risk management causes gaps and noncompliance.

MasterControl’s QMS – Integrates with all other quality processes for a holistic approach to quality.