Transitioning to CSA

US FDA has laid out broad guidelines in transitioning from the traditional validation methods to CSA based on a risk-driven culture, which impacts patient safety, product quality and data integrity. We at Valina, can help you to take this journey.


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.

Risk-based Requirements

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.

Critical Thinking

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.

Testing vs Qualification

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.

Light Weight Documentation

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.

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