Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory

GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. T