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What You Need to Know about a Risk-Based CSV Approach

What You Need to Know about a Risk-Based CSV Approach

In the biopharmaceutical field, it's essential for regulatory, clinical, and IT staff to make sure computer systems work well by using smart computer system validation methods (CSV).

Laura Hatchard

The FDA’s General Principles Validation framework helps by allowing companies to apply a critical risk-based approach to their computer system validation activities. By staying up to date on these practices, experts can ensure systems run smoothly.

Understanding Risk-Based CSV

The FDA’s framework allows manufacturers to a use a smart risk-based method, focusing on critical areas that directly impact product safety and quality. This approach adjusts documentation based on how much system changes or updates might impact things.

Getting started with a Formal Risk Assessment

Every CSV journey should begin with a thorough risk assessment. This should include a response plan for:

  • What could go wrong?
  • How likely is it that the system will require downtime?
  • What are the consequences of the system not functioning properly?

From there, you should approach by categorizing the risk of each computer system.

Prioritizing Computer Systems Risk

To save time and resources it’s important to prioritize validation efforts based on the identified risks. High-risk functionalities require meticulous validation, whereas lower-risk aspects may use streamlined validation processes.

Risks in your computer system can be identified by understanding their likelihood to occur and characterizing each into the following categories:

  • High: Direct impact on data integrity, patient safety, or product quality.
  • Medium: Indirect impact on data integrity, patient safety, or product quality.
  • Low: No impact on data integrity, patient safety, or product quality.

Collaborating with validation experts, the customer system vendor and stakeholders can help in comprehensive risk identification.

Creating a Computer Systems Risk Assessment Plan

Once you’ve identified the risks in your system, you should document how you will respond should these occur. This should include identifying appropriate controls and verifying that the controls are applied successfully.

If software or hardware is updated or significantly changed, reassessment and revalidation is imperative to ensure the system still functions as intended.

Not every change to a computer system requires complete revalidation. Save time by pinpointing changes that don’t affect the system’s functionality and documenting procedures in your Quality Management System (QMS) to address them. Examples of such changes include:

  • System access updates
  • Creating rights and roles
  • User-level operations
  • General configuration modifications

If you’re looking to learn more or need assistance with your validation needs, feel free to reach out to your local team. We’re here to support you through the computer system validation process and ensure everything runs seamlessly. Let’s collaborate to keep our systems operating efficiently!

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