Published: January 2010
During the operational life of a GxP system, regulators usually focus on the integrity, consistency, and completeness of controls required to maintain compliance. The GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems highlights the importance of the operation phase of the system lifecycle, when it is more likely that the return on investment will be achieved for the significant time and resources expended in implementing new computerized systems. The Guide will help regulated organizations create regulated computerized systems that are fit for intended use and compliant with applicable regulations and provides comprehensive guidance for maintaining control of regulated systems throughout their operational life.
|Available in German|
|GAMP® Gute-Praxis-Leitfaden: Ein risikobasierter Ansatz für den Betrieb GxP -computergestützter Systeme
(Ein Begleitband zu GAMP® 5)
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