LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 3 –SUMMARIZING
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LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 3 –SUMMARIZING

This is the last installment of a three-article series that presents several lessons learned by our validation team while completing a pair of validation projects...

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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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