What is Computer Software Assurance?

28 September 2021

What is Computer Software Assurance?

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What is Computer Software Assurance?

The speed and efficiency of computer software validation (CSV) has emerged as a key focus over recent years, with the FDA set to release their new approach: Computer Software Assurance (CSA) in 2021.

But why is there a need to shift away from CSV, and what exactly does the new approach entail?

During a 2011 review of medical device quality data, the FDA’s Center for Devices and Radiological Health (CDRH) detected manufacturing risks that were impacting product quality. This prompted them to launch their ‘Case for Quality’ initiative.

One of the key findings of the initiative was that Computer Software Validation (CSV) had become a burden for life science companies. CSV seemed to have shifted the industry's focus to passing audits with extensive documentation requirements. They also found that less time and effort was spent concentrating on quality.

Most companies have been deterred from investing in automated systems due to the frustrations that come with CSV. For the past two decades, CSV has remained mostly unchanged. However, with the advances in software (which have been elevated due to the pandemic), the FDA must now bridge the gap between regulation and technology.

To address these issues, the CDRH and FDA will release a new guidance document later this year entitled ‘Computer Software Assurance for Manufacturing and Quality System Software’. The new FDA guidance has changed its emphasis to a more risk-based approach known as Computer Software Assurance (CSA), which allows manufacturers to concentrate on areas such as product quality, patient safety, and speed to market.

Traditionally, the FDA’s CSV has prioritized documentation, followed by testing activities, assurance needs, and critical thinking. However, the new CSA model will focus on critical thinking first, followed by assurance needs, testing activities and finally, documentation.

What is CSA and what will it focus on?

CSA aims to reduce unnecessary documentation whilst still assuring that the software is fit for purpose and that any risks are mitigated. This new approach will focus on:

  • Critical thinking: Risk definition for each software feature
  • Assurance: Demonstrate if the feature and functionality is working as desired
  • Testing activities: Leverage and define the different test methods like scripted and unscripted testing.

What are the benefits of the FDA’s Computer Software Assurance approach?

  • A reduction in cycle times such as test creation, review, and approval
  • A risk-based approach means systems can be broken into features, so only those of high-risk will require scripted testing
  • Reduced test script implementation time
  • Reduced number of generated documents
  • Testing focused on guaranteeing software quality
  • Better use of supplier qualification
  • Reduced time-to-value in product development

The need for speed

Typically, software validation can take four to eight months or more for a single system. The new approach will see reduced software development and implementation times, lower costs, and decreased documentation for life science companies.

As the FDA prepares to release its new CSA guidance, they have advised manufacturers to take a proactive stance in their approach to the new CSA methodology. This should focus on patient safety, product quality, and data integrity.

Those who take this proactive approach will be part of an innovative new system, putting the needs of their patients first by developing high-quality products in a timely manner. Conversely, those who fail to take this approach may run the risk of falling behind in the race to market.

How to get your organization ready for the shift to CSA

The FDA strongly advises life science organizations to start getting ready for CSA now. To find out more about how your business can take a proactive approach to the transition, download our guide, 'Gearing up for the FDA's transition from CSV - CSA' now.

Download guide


Ideagen's content executive Chloe Weaver
Written by

Chloe Weaver

As Ideagen’s Content Marketing Executive, Chloe produces engaging content to inform and educate customers on the intricate world of quality, audit, risk and compliance. With a journalistic background in renewable and nuclear energy, Chloe is passionate about creating content to educate, enlighten and inspire customers.

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