Recently, we helped a client adopt the CSA approach for software validation over the traditional CSV approach that had been in place since the company’s inception. Instead of allocating time and resources to developing traditional IQ, OQ, and PQ testing of basic system features, such as the ability to login and menu placement, the team examined their business processes and the software configuration aspects necessary to support those processes. Efforts then focused on testing the business processes related to patient safety, product quality, and data integrity within the context of the software configuration.
The validation team, comprised of IT, QA, and business stakeholders, found this to be a much more efficient approach to software qualification. They designed and executed a smaller set of risk-prioritized use cases, resulting in a quicker path to system validation. The complete validation package included vendor-provided materials to document the more traditional validation requirements such as the quality of software features and IT infrastructure.