Computer Software Assurance (CSA) is a risk-based approach to computer systems and the software used. This approach is product quality-focused and patient-centric. Computer Software Assurance follows a critical thinking approach while still focusing on patient safety, product quality, and data integrity with risk-based testing and less documentation.
With the benefits of using Computer Software Assurance FDA observed that only a few companies opted for automated solutions. Many continued using outdated software versions during the launch of their Case for Quality initiative in 2011. The FDA decided to partner with the industry to promote automation in medical devices and improve their quality.
Most people think CSA replaces the current System Computer Validation (CSV), which is not valid.
The Difference between CSA and CSV
CSV focuses on computerized systems and includes the processes around the design, while CSA focuses more on the software and the computer system.
CSV focused more on documentation and scripting and less on critical process thinking. Most of the efforts were spent on validation, documentation, testing, and reconfirming the previous testing. The approach was all about testing and documentation to satisfy auditors. This approach never focused on high-risk processes.
The critical thing in CSA is vital thinking and as little documentation as possible. Most of the efforts are focused on risk evaluation and prioritized testing, which is sometimes automated and not scripting as in CSV. This approach dramatically reduces the workload, shortens the process, and ensures more focus is on high-risk areas of the system.
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Scripted versus Unscripted Testing: the Difference
Scripted testing, also known as traditional testing, contains at a minimum a test objective for the test script, step-by-step procedure, expected results, and a pass or fail. Scripted testing is used to test higher-risk systems as the software directly impacts the product or patient safety.
Unscripted testing is the testing carried out without using detailed test scripts. Unscripted testing tests lower-risk systems as the software does not directly impact the product or patient safety. It only affects the quality system. There should always be Pass or Fail but no step-by-step procedure.
Computer Software Assurance Benefits
Computer Software Assurance reduces customer validation and assurance efforts by:
- Speeding up the whole process
- Saving time and cost
- Reducing efforts for testing and documentation
- Focusing on the high-risk parts of a person’s systems
- Lowering the number of detected defects such as script errors and configuration
- Concentrate on ensuring SW Quality
- Ensuring better use of Supplier Qualification
- Maximizing the use of CSV and Project Resources expertise
- Releasing CSA guidelines that support companies who have taken the automation path
How to Transition from CSV to CSA
- Know the high-risk features, operations, and functions of computer systems
- Review and update current policies to align with the CSA approach
- Know the use of the computer systems
- Use computer validation tools to automate assurance activities
- Change the culture of the organization from a compliance-centric mindset to quality-focused culture
- Perform supplier audition
There is revalidation, retrospective validation, concurrent validation and prospective validation.