Computer Software Assurance as the name suggests is to assure that the software product or solution is consistently performing based on its intended usage, which has been proven through a series of tests.

CSA emphasizes on risk-based computerized systems classification and estimating the validation efforts and planning the activities. Hence, the requirements should be assigned a certain risk based on the parameters of patient safety, product quality and data integrity.

The first step in the CSA is critical thinking, which is the science of risk-based validation planning and implementation. Attaching an element of risk in the form of Functional Risk Assessment, Technological and Compliance Risk-Assessment would add value to the process of Critical Thinking.

CSA allows the provisioning of conducting basic testing on low-risk items, which are a spin-off from the requirements and system design activties conducted prior. The testing should be commensurate with the right amount of rigor and a trade-off with Qualification should be weighed in terms of its realizable benefits.

The validation package could be reduced with combination of some documents or hiving off the low-risk elements into a different test document. The efforts towards maintaining the validation package becomes easier with less documents.