Blog Post
LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING
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...
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Blog Post
LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING
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...
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Blog Post
Is CSA Really a Game Changer for the Life Science Industry?
Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry...
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