Last month, the FDA issued the draft of a new guidance for Computer Software Assurance (CSA) for computers and automated data processing systems. The goal? To describe how can CSA simplify your Validation process. 

Let’s dive on what is it all about. 

Validation only goes so far 

Software validation is usually achieved through software testing and other activities performed during its development.  

But, as thorough as this process can be, it’s not enough to proof that a software is fit for its intended use.

Overcoming these limitations 

The logic behind CSA is to prevent the introduction of defects into software. 

This is done by assessing the risk of safety and/or quality compromise and, from there, define the assurance effort and what activities are necessary to make sure the software is trustable. 

What happens is that, by using this risk-based approach, the validation efforts can be better focused. This means a better resource use, a simpler process and a superior product quality. 

Taking the steps towards CSA 

In order to accomplish CSA, you need to take a few steps. These are: 

  • Identify the intended use 
  • Determine the risk-based approach 
  • Define the appropriate assurance activities 
  • Establish an appropriate record 

More agility, less paperwork 

As software development life cycle methodologies evolved from the well-known Waterfall used as a basis for the GAMP into Agile and DevOps, the validation of a computer system is no longer a one-time activity based on documentation. 

But, more importantly, the transition from CSV to CSA reduces the amount of paperwork.  

And, as we’ve seen, it does so by leveraging the manufacturer’s experience and robustness of its QMS (Quality Management System), in which it is crucial that testing follows the best practices including emerging methodologies and tools, such as ATDD (Acceptance Test-Driven Development), Session-based testing and automated testing. 

Curious about the transition to CSA? 

If the topic of transition to Computer Software Assurance is something that interests you, you can check our work on the subject such as: 

Making a smooth transition from CSV to CSA 

4TE is ready to support your transition from CSV to CSA, from a detailed assessment of your current QMS and computer systems inventory to identify the best transition approach, going through a supplier qualification and culminating into a validation of upcoming computer systems in your current environment. 

We recommend that you check our Computer System Validation Services. If you think we may be able to help you out, don’t hesitate to book a call, we’ll do our absolute best to help.