CSA is an easier and less-resourceful way to validate your computer software. The good news is that if you already use a Digital QRM system you’re one step closer to easily implement CSA.  

Let’s see! Imagine that you have something to do, your brain is going to rapidly process how important that action is and what are the consequences of not doing it (or of doing it wrong). This makes you decide the amount of effort to put in that action.   

This is the rationale behind using QRM for the validation of your software. Indeed, by using a Digital QRM System, this becomes much easier and more automatic, which is what we’ll explore in this blog post. Let’s check it out!  

Moving towards CSA 

From the FDA recommendations on CSA, the focus of validation should not be to produce a large amount of documentation. Instead, it should be about ensuring that a system does not negatively impact your product quality, patient safety or data integrity. [1] 

And the point is that it can be done with much less documentation that the traditional validation. 

CSA does that using two key elements: critical thinking and a risk-based approach. If you can effectively prevent the introduction of quality or safety compromising defects during the software development process, you don’t need to test the software from top to bottom.  

Going after the Risks 

Basically, if you want to apply a risk-based approach to your validation you need first to figure those risks and their consequences. And from there you can evaluate their impact.  

In order to do that, we recommend answering the following questions: 

  • What products are affected by the usage of this computer system? 
  • What are the critical quality attributes of those products? 
  • How will the computer system affect those critical quality attributes? 
  • What are the regulatory rules applied to the process(es) affected by the computer system? 
  • What data will be captured and/or processed by the computer system? 
  • Which data captured and/or processed by the computer system is subject to regulatory inspection and retention? 
  • What are the know issues related to the products and processes affected by the usage of this computer systems? 

From these answers, you can map the risks and their impacts and perform your assessment.  

And, accordingly, determine the level of assurance and activities necessary to accurately validate that system. 

Finally, instead of simply validating the whole software, you start by considering the risks of the system compromising safety and/or quality.   

The benefits? It makes the validation activities more effective, more efficient, and less costly! 

Emphasis on Risk Management  

FDA recommends using a risk-based analysis to identify predictable software failures and determine if such failure has high-risk consequences for the process. With this, you will categorise your risks by different types and levels.  

And from there you can determine the appropriate activities:  

Digital QRM as your ally  

Now that is clear how a robust risk management system leverages the application of CSA, we’re getting to the part of how a digital QRM system can support it.  

A digital QRM platform can help you to identify, quantify and categorise risks related to your computer system in a user-friendly way using several QRM tools.  

Additionally, it allows your entire team to be involved on risk management throughout any validation phase of your computer system. Regarding document activities, it also brings benefits since you have all the information compiled in one place. 

How 4TE can support your CSA implementation 

4TE has a strong expertise with QRM optimization and digitalization to support organizations manage their risks. We can help you to take the most out of your digital QRM to implement your CSA and benefit from a simplified validation process. 

If you’re interested in going further in simplifying your validation process, shifting to a paperless automated validation lifecycle management system (VLMS) will also save you time, money, and effort. 

So, if you think we may be able to help you out, don’t hesitate to contact us

Do you want to know more about CSA? 

Check our blog posts about it: 

How can CSA simplify your Validation processes  

User Requirements Specification: Creating one for CSA 

Transitioning from CSV to CSA 

[1] U.S. Food and Drug Administration, “Computer Software Assurance for Production and Quality System Software: Draft Guidance for Industry and Food and Drug Administration Staff,” 2022. Accessed: Nov. 23, 2022. [Online]. Available: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software