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

GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500.

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Member Price: $ 250.00 / € 230.00
Non Member Price: $ 570.00 / € 500.00
Item #: 5BOUNDUS

Pages: 356
Publishing Date: 02/08