March 18, 2024 || Brian Stephens
This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects that used the FDA’s draft of the Computer Software Assurance for Production and Quality System Software Guidance (CSA). The number of resources, the amount of…
February 12, 2024 || Brian Stephens
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer Software Assurance guidance in September 2022. Since that time, I have used this guidance to reduce the effort and cost required to complete two large…
June 11, 2020 ||
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…
