GAMP® Good Practice Guide: IT Infrastructure Control and Compliance

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Published: September 2005
Pages: 128
Table of Contents ( 62 KB)  

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The validated status of GxP applications that are dependent upon an underlying IT Infrastructure is compromised if that IT Infrastructure is not maintained in a demonstrable state of control and regulatory compliance. The consequences of the IT Infrastructure being out of effective control can be significant. Depending on the nature of a failure, an entire site or geographic region of operations could be brought to a standstill while the problem is resolved.

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