This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Dennis Cantellops
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Dennis Cantellops is an independent GMP and data integrity consultant and a former consumer safety officer for the US Food and Drug Administration.
Articles by Dennis Cantellops
This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.
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