Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry has been waiting for from the FDA? Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto…
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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