GAMP IT INFRASTRUCTURE CONTROL AND COMPLIANCE PDF

Yves takes care of computerised system validation since Since , he works as consultant, auditor and trainer for all aspects of quality management in automated and IT environments particularly within the regulated industry — pharmaceutical industry, medical device manufacturing, blood transfusion services — and for its suppliers. He supports Quality Assurance and development departments regarding e-compliance for automated and IT systems. In , he founded the consulting company Kereon AG, Basel.

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GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)

The increasing prevalence of new technology has presented regulated companies with significant technological advantages, as well as a changed compliance model. The validated status of GxP applications that are dependent upon an underlying IT Infrastructure can be compromised if the IT Infrastructure is not maintained in a demonstrable state of control and regulatory compliance. Data integrity can also be affected by problems related to IT Infrastructure, leading to increased risks which can in turn affect product quality or patient safety. The Guide applies a structured approach, including risk management, to the qualification, management, and control of IT Infrastructure platforms supporting GxP regulated applications. The Guide provides a scalable qualification framework which can be applied to different platform types, across both the physical and virtualized space, in order to determine the extent and scope of qualification efforts.

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