What To Expect When You Adopt CSA

Computer Software Assurance (CSA) is a risk-based approach to software validation. It focuses on reducing unnecessary testing while designing meaningful documentation and testing that protects data integrity, product quality, and study participants’ safety. The FDA first released a draft guidance for CSA in 2022, and today regulatory professionals have begun adopting this new methodology and enjoying the benefits of this streamlined approach to validation.

But as with adopting any new methodology, moving to CSA requires some adjustments to your process and expectations. Here are a few important things to consider when making the switch.

  1. Extended time to adjust SOPs/SOIs: Ensure you have a thorough understanding of how many SOPs/SOIs will need to be updated to reflect the new CSA approach.

  2. Extended project start timelines: CSA begins with an assessment of risks in order to determine necessary testing activities, so your project start-up must account for this.

  3. Critical role of the business owner: The business owner needs to thoroughly understand the intended use of the system and advise the team during the risk assessment.

  4. Getting the risk levels right: The ultimate safety and reliability of the system relies on knowing which parts of the system are high-risk, and which are not.

  5. Collaboration is crucial: Team members need to understand each other's goals and objectives to correctly assess dependencies and risks.

  6. Change management needs to be strong: Adapting to changes in technology and requirements while maintaining system assurance is a delicate balance.

  7. You need vendor partners: CSA enables you to leverage the vendor’s testing activities, so having a strong partnership with the vendor (with clear expectations about what they can provide) will make for a smoother implementation.

Implementing CSA brings great benefits, but you need to make the switch with an understanding of the challenges you might encounter. Setting your expectations appropriately will ensure that your CSA implementation supports your broader goals of quality, compliance, and innovation.