The Essentials of FDA Computer Software Assurance

The U.S Food and Drug Administration (FDA) requires companies under them to do personal validation to ensure their software and systems are performing optimally. That is why the Computer System Validation has been in operation for the past 20 years in the regulated sector. However, this technique has been under increased levels of improvement.

People who have been using the CSV throughout have near equal levels of hate and love for this program. While the initial intention of the CSV was to make the whole process more efficient, some challenges have seen the method fail in vast areas. These problems span the various concerns, including in-depth automation, cloud developments, and a complicated 21 Code of Federal Regulations.

What this means is the increased level of inconsistencies and ambiguities in the computer software and system innovations. It is pretty evident, for instance, that automation will bring a host of issues that, in essence, will require better ways to improve them. Apart from that, the CSV itself is falling short in enhancing the automation quests by offering heaps of documents for audit purposes.

With all these, FDA has seen it wise to narrow the gap between the evolving technology and its measures in offering guidance. Essentially, this is where computer software assurance comes in to offer solutions where the CSV failed. This modern-day approach aims to solve the Pain Points of CSV, which are seen as a great hindrance in using technology to the required maximum. Some of the pain points include:

  • Automation discouragement
  • Audit evidence focus
  • Unacknowledged supplier documentation efforts
  • Complex risk assessments
  • Human error responsible for 80% of deviations
  • Post-go-live problems

The Computer Software Assurance Solutions

The computer software assurance is set to address these pain points in the following ways.

Automation discouragement

The FDA’s view is to encourage automation in the tools and other IT solutions. No one can doubt the great strides automation has taken to make life easier in various scopes. So it makes perfect when software developers leverage from this. Automation can help optimize the use of resources, reduce patient risk, and reduce errors in testing. Undoubtedly, this is a green light that is going to see more advancement in software automation.

Audit evidence focus

CSV’s main pain point was on the heaps of documentation. This is not only a hindrance to automation but is also a hefty case to handle. Also, there have been near-zero cases or no critical thinking in using documentation when it comes to computer software validation. For this reason, computer software assurance attempts to shift this paradigm back to critical thinking. This will mean developing an approach focused on addressing the patient risks with more concise testing in place of documentation.

Unacknowledged supplier documentation efforts

The truth is that even the most trusted vendor companies will, in one way or the other, reproduce documentation. And that what the CSA solves by offering guidelines that in case of vendor documentation is there, then it should be copied.  Here, more effort is directed to ensure that the software works for the intended purpose instead of repeating vendor documents.

Complex risk assessments

The computer software assurance’s approach is going to be based mainly on the intended use. That means limiting the risk assessments to clear systems usage cases. For instance, there will be no need to validate a software out of context. It is crucial to note that the riskier the software, the more documentation and testing the facility will require.

Human error responsible for 80% of deviations

Unlike the CSV, the computer software assurance recommends a streamlined risk assessment with two variables. That is the potential impact on the patient safety/product quality and the method’s functionality implementation. Typically, this eliminates the case of Failure Mode Effect Analysis.

The Bottom Line

While the transition of CSV to CSA is yet to be fully implemented, it is an excellent idea to understand all the requirements. While at it, considering some steps like changing the culture from a compliance-centric mindset to quality-focused culture will come a long way to make a significant difference. Also, it makes perfect sense to know the suppliers and the intended use of the computer system. This way, the user will understand the risk features, operations, and functions of the computer software and know the existing gaps in the current validations.

Moreover, it is crucial to note that CSA is pro automation. That is why computer software and system experts will have to major mainly on this. Automation is a tool that will lead to the production and use of higher quality medicines. Plus, this will reduce risks that patients have to undergo whenever substandard products are on the line of care.

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