5 Misconceptions about Computer Software Assurance (CSA) 

Computer Software Assurance (CSA) emphasizes a flexible, risk-based approach to software validation, focusing on critical aspects of software that impact data integrity, product quality, and patient safety. It is becoming a popular addition to traditional Computer Software Validation (CSV); but as with any new methodology, it is important to recognize what CSA is and what it isn’t.  

Here are five common misconceptions about CSA to consider before you make the switch: 

  1. Unscripted = No documentation: FALSE. CSA puts an emphasis on less documentation, but testing still must be accompanied by a record of completion and evidence commensurate with the criticality of the function. 

  1. Screenshots are required for all tests: FALSE. In most cases, indicating that a particular test passes or fails suffices as evidence because the audit trail will contain the respective details. 

  1. All test defects and test errors must be documented using the same defect process:  
    FALSE. Error documentation may include more than one approach to ensure the information is captured in an effective way. For example, testing errors may be documented within test script actual results, whereas test defects for system issues might follow the defect process using compliance reports or test reports. 

  1. CSV is being eliminated and replaced by CSA: FALSE. CSA offers an additional flexible, risk-based, and efficient approach to software validation, but it does not replace CSV. The decision to use CSA vs. CSV should be based on the inherent risks and level of documentation necessary for assurance.  

  1. All assurance/testing activities must be performed in the Quality (QA) environment: FALSE. Assurance/testing activities can be done in different environments as per the activity's intent. 

CSA is a risk-based approach to software validation, considering the potential of compromised safety and/or quality to determine the appropriate level of assurance effort and activities. It goes beyond the traditional verification of system design to provide confidence in system performance while supporting a more efficient use of resources. Embracing CSA with a clear understanding of its principles, benefits, and limitations can lead to more efficient and effective software assurance processes.