What’s all the fuss about CSA and why is it becoming important to computer software validation, especially for MedTech companies? CSA is a methodology for process improvement by which you change the way you perform validation through planning, assessing, automating and implementing.
It requires replacing old processes with new processes, developing success criteria and metrics, such as Key Performance Indicators (KPI) and/or Software-Level Agreement (SLA with suppliers/vendor/partners, and addressing the barriers to transformation your organization’s change management (OCM).
New technical competencies need to be developed through learning management programs to train employees on the new FDA guidance. Software Suppliers and Vendors assume responsibility for compliance with FDA regulations during development.
This saves time, resources, and more and assures that the software works the way it was intended to. For more information see RCM’s whitepapers and blogs.
See Case Study: HERE