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GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems

White Paper

GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems

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The GAMP 5 provides a framework of good practice for validation of computer systems used in complying with GxP regulations. This white paper provides an overview of the guidelines and explains the five-step risk management process to help manufacturers determine the best approach in system validation.

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