The Computer Software Assurance method (sometimes also called Computer System Assurance) came about entirely because of the challenges posed by the practical application of Computer System Validation (CSV) approach. CSV was not manufacturer-friendly enough and we moved away from Risk based (critical thinking) principles as mentioned in the GAMP5®. The CSV process had many tiresome items, from wasted time to unnecessary documentation. It had become more of an effort to provide sufficient evidence for auditors than to ensure quality. The FDA (Food and Drug Administration) together with the industry CSA team (FISCA) has identified the obstacles to this approach as follows;

  • Complex, confusing, and hard to use risk-based approaches
  • Too much focus on documentation and not delivering a patient safe product
  • Uncertainty about the focus and adequacy of the tests


The documentation demands of CSV and its lacking concentration on quality have become a complete scourge for pharma companies. There have been companies that have discouraged investing in automated systems due to the bias created by CSV. And to bridge this gap between regulation and technology, the FISCA team has introduced an additional practical guidance named Computer Software Assurance for Manufacturing and Quality System Software. The focus of this new approach was different from that of CSV and was intended to lighten the burden.


 Focus points of CSA;

  • Critical Thinking (understand what you are doing and why you are doing this)
  • Concentration on product quality
  • Patient safety


It seems that what CSA is trying to do is actually to free the process from unnecessary documentation, by applying critical thinking, as it was intended by the GAMP5 ® and therefore without losing the intended use of the software while continuing to mitigate the risks.

So, what are the benefits of CSA? What exactly does it do?

  • Emphasizes critical thinking; you have to understand your process, system, and risks to spent time on those activities actually ensuring quality.
  • Reduces time spent on test protocol creation, review, and approval
  • Works to guarantee software quality
  • Has a risk-based approach and it gives us the ability to focus the testing approach on the criticality of the functionality
  • Allows for better utilization of supplier qualification
  • Shortens script implementation, review and approval time
  • Focus on valuable documents
  • Decreases time-to-value in product development


CSA also focuses on;

  • Assurance needs
  • Testing activities

Software validation requires very long periods, sometimes up to 8-9 months or even more. CSA paves the way for saving implementation time and cost in this process. Lightening the documentation load allows companies to breathe a sigh of relief.

Be aware that CSA requires personnel who know what they are doing and who know their processes and risks.

The FICSA team, which is the provider of this approach, advises manufacturers to take a proactive stance. In this way, manufacturers can produce high-quality products and be part of a new system that puts patient safety and data integrity at the focus point. Those who oppose the approach may fall behind in the rat race in the market.


If you need help or support or you want to get more details about it, do not hesitate to contact Rescop Professionals!

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