CSV Risk Management

Risk Management is a thread that runs all the way through the Computer System Validation (CSV) process, from Initial Assessment to final testing, as covered in a series of C-realize blog articles (see Resources).

CSV Risk Management involves identifying, evaluating, mitigating, and documenting the risks associated with computerized systems that could impact product quality, patient safety, or data integrity.

Identifying risks

Risk management within the validation project begins in the Initial Assessment stage discussed previously (see Resources).

This process will make use of the different input sources including product and process knowledge, user requirements, vendor assessment, criticality and complexity of the system.

Analyzing risks

There are a range of methods and tools that can be used to analyze and quantify identified risks. A widely used in the life science industries method is the Failure Mode Effects Analysis (FMEA).

However, while FMEA works well for complex systems  simpler approaches aligned with FDA’s Computer Software Assurance guidance may be more efficient and just as effective.

Risk mitigation

After differentiating the functional areas that are low risk from those that are higher risk, the CSV process can then turn to identifying the measures needed to mitigate and control these risks.

This can use strategies that include:

• adaptation of system design.
• training of personnel.
• controls that will allow early detection of potential failures, breaches and harm.

Any controls implemented should be reassessed for their efficacity at the end of the project.

Ongoing risk management

The need for ongoing checks emphasizes that risk management should also not be limited to the validation project but should be monitored throughout the systems lifecycle. In particular, risks need to be re-assessed when changes occur or during periodic reviews.

Resources

Click on CSV Fundamentals: Validation Planning to read previous article in series.
Click on C-realize blog to read entire Computer System Validation series.

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