Computer software assurance (CSA) is a topic of keen interest in the life sciences industry. The U.S. Food and Drug Administration’s upcoming CSA guidance (Computer Software Assurance for Manufacturing, Operations and Quality System Software), is expected mid-2022 as of this writing (March 2022). Understandably, companies awaiting updated guidance have numerous questions and concerns.
This e-book from ValGenesis offers educational insight to help industry stakeholders better prepare for, adapt to, and abide by upcoming CSA guidance. With the following key insights, ValGenesis helps you evolve and adapt to industry changes with greater ease.