Is Computer Software Assurance (CSA) A Game Changer For Life Sciences?

By Brian Stephens

Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto life science companies for the past two decades, with less-than-desired results. The FDA’s upcoming CSA guidance promises to be a useful tool to help the industry finally achieve this elusive goal.

The last FDA guidance proposing significant changes in validation approaches came out in 2004, the Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century¹. It promotes the use of the latest technology, the newest quality methodologies, and a risk-based assessment of system functions to achieve compliance more efficiently than previous methods used in the 1990s and earlier. Still, the industry has been slow to adopt the philosophy and implement the suggested changes. This lack of acceptance has been due to the initial cost to employ new technology and processes, the perceived lack of maturity of some of the technology, and the resistance of companies to changing their processes from FDA “known and accepted” validation methodologies currently in use. The draft of a new guidance on the topic, “Computer Software Assurance for Manufacturing, Operations, and Quality System Software,” is scheduled for release by the Center for Devices and Radiological Health (CDRH) before the end of 2020² to streamline the validation of systems using non-product software. Since this guidance will not present any information that has not been stated in previous guidance, and it will not require any changes to existing guidance or predicate rules, what benefits will it bring to the life science industry?