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Integrated Risk Management: Go Beyond Compliance

To ensure patient safety, proactively detect signals and trends and continuously improve device quality and safety, integrating quality risk management with the quality management system (QMS) is essential. In our latest article, we consider the benefits of this integration and address the growing complexity of risk management.

The Elements of a Successful CAPA Process

To date, the most widely-used and effective process for ensuring safety and quality management is a closed-loop corrective action and preventive action system (CAPA).

Root Cause Analysis - Blog

5 Steps to Performing an Effective Root Cause Analysis

Conducting a root cause analysis (RCA) is an essential problem-solving method used to isolate and identify concerns. RCA goes beyond simple cause and effect to identify failure points in a process or system.

Shaping the Future of Quality at the RQA Virtual European QA Congress

"Transformation is a dramatic change. It is an alteration. It is not doing the same thing we did thirty years ago but now using a computer."

Sparta Experts Present Their Insights on Digital Quality Transformation and Supplier Management

On March 30th and 31st, Sparta Systems, A Honeywell company, was a proud platinum sponsor of the 5th...

How Pharmaceutical Quality Drives Performance

While many pharmaceutical and biotech companies have begun investing in their quality systems, it’s not uncommon to still...

Overview: Sparta Experts Speak at the RQA International QA Conference

Did you miss it? Here are some highlights from Sparta’s expert sessions.

Beyond Compliance: The Benefits of Integrated Risk Management

To reduce harm to patients and users, quality risk management must successfully integrate with the quality management system.

Quality Challenges Facing the Medical Device Industry

Medical device companies need a solution that mitigates quality challenges with supply chain quality management, complaint handling and reporting processes.

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