ISPE GAMP® 5: A Risk Based Approach to Compliant GxP Computerized Systems (Second Edition),1
ISPE GAMP® 5: A Risk Based Approach to Compliant GxP Computerized Systems (Second Edition),1
This article describes a practical and pragmatic approach to the management of computerized system life cycle and information technology (IT) process records. The objective is to effectively achieve and maintain compliant GxP-regulated systems that are fit for intended use, and to support patient safety, product quality, and data integrity.
This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative
In the previous blog, GAMP® Support for Pragramtic Quality & Risk-Based Approaches, we saw how as part of the Case for Quality program US FDA CDRH (Center for Devices and...