LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING
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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LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING
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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Is CSA Really a Game Changer for the Life Science Industry?
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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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