Pioneering Progress: How Innovation is Transforming Manufacturing Operations
Manufacturing has entered a new era in which success depends on more than traditional optimization methods. While Lean and Six Sigma have served as foundational...
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The Future of AI-Driven Operational Readiness – An Outcome-Based Approach to Enhanced Process Validation and Asset Performance
As AI and related technologies continue to advance, the potential to reshape operational readiness grows exponentially. The future of AI for use in operational readiness...
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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
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
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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