Computer Software Assurance (CSA): What Are Assurance Needs?

In traditional Computer System Validation (CSV), assurance needs sit near the bottom of the hierarchy. CSV prioritizes documentation first, followed by testing, assurance needs, and finally critical thinking. However, in the FDA's modern Computer Software Assurance (CSA) approach, assurance needs move close to the top, second only to critical thinking. The graphic below illustrates this shift in priority within the CSA framework.

As their importance grows, clearly defining assurance needs and understanding what must be addressed in this phase becomes essential to adopting the FDA CSA guidance effectively. 

What Are Assurance Needs?

In a nutshell, assurance needs refer to the activities required to ensure that a computer system operates as intended. According to the FDA's Case for Quality initiative, determining these activities is a three-step process.

1. First, you must identify the intended use of the system, which is explained in the user requirements. 
   
   
2. Second, you must employ a risk-based approach to pinpoint the high-risk areas of the system, focusing primarily on areas that directly impact patient safety. 
   
   
3. The third and final step is to determine when a failure in these identified areas will have a high-risk impact on the system's quality and safety. These areas will require the most rigorous validation.

Risk-based Assurance Activities

Once you have determined the assurance needs of the system, you will know the activities you must perform to address these needs. Key activities include:

• Meet and validate user requirements: The intended use of the system must be clear. You must ensure that all user requirements have been met and validated and that using the system does not jeopardize quality or safety, with patient safety being the primary concern.
  
  
• Ensure you are working from a quality-centric (not compliance-centric) mindset: The driving force behind CSA is the need to reclaim the quality-centric mindset lost to CSV. With CSV, the focus is on gathering documentary records for auditors. But focusing too much on regulatory requirements and compliance can cause (and has caused) life sciences professionals to lose sight of quality. Take an honest look at your organization. Do you have a quality culture? If you do, compliance is more or less assured.
  
  
• Conduct a risk assessment: Assessing risk at the beginning of the validation initiative is critical to avoid wasting time and resources validating low- to medium-risk areas that do not warrant the highest degree of rigor. Risk-based assurance requires applying the appropriate level of rigor for the determined level of risk to patient safety or product quality. The risk assessment drives everything else that occurs during the software validation process.
  
  
• Leverage available tools: The advancement of new technology means we have many tools at our disposal to perform validation. The CSA methodology encourages the use of computer system validation tools to automate assurance activities.
  
  
• Test appropriately: Testing is the third phase of CSA, but determining which testing methods (scripted, ad hoc, exploratory, or automated) to use and how much testing is required starts in the assurance needs phase. The overall goal is to focus more on testing, less on scripting.
  
  
• Identify documentation needs: Documentation is the fourth and final phase of CSA, but again, understanding the assurance needs associated with the documentation you will produce starts during this phase. What is adequate documentation? What is the objective evidence? These are the questions you must consider.

The End Goal

In the assurance needs phase of CSA, you must demonstrate that the software will perform as intended and that you are using the right technologies, techniques, and systems (manual and automated) at the right time. The ultimate goal is to ensure that everyone, including regulators, is confident that the validation effort meets or exceeds your quality standards and aligns with regulatory requirements.

Putting CSA Into Practice With a Risk-Based, AI-Driven Digital Validation Suite

CSA depends on clear intended use, thoughtful risk assessment, and selecting the right level of assurance for what matters most. But applying these principles consistently is difficult without tools that support risk-based decisions, streamline testing, and ensure reliable evidence.

A digital validation platform can help teams carry CSA forward in day-to-day work by connecting requirements, risk, testing, and documentation in one place. It reduces manual effort, improves traceability, and supports the level of assurance expected under the FDA’s CSA guidance.

Learn how ValGenesis Validation Lifecycle Suite (VLS)—powered by AI—can support your CSA approach.