Gamp good practice guide it infrastructure control and compliance pdf
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Compliance and Frameworks - CompTIA Security+ SY0-501 - 3.1
‘Have you heard of CSV?’ part 6. CSV and the Cloud.
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In the last few years, a new way of computing has attracted life sciences companies, one that most of us use often for online data storage or for our email needs. There is plenty of information available that describes what the Cloud is and how it is utilized in general. In this article we briefly introduce the Cloud and we examine its relationship with Computerized System Validation CSV in the life sciences industry. We follow the guidance given by the four points below:. The Cloud offers its users a variety of service models Fig. In the life sciences industry, although the CSP cares for the data residing in the Cloud, it is ultimately the responsibility of the customer i.
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 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. The Guide also provides an overview of industry best practices for the design, qualification, and operation of an IT Infrastructure with emphasis on the qualification requirements of the major components. The revision expands the scope of the Guide to include guidance on the emergence of cloud and virtualized technologies. Information has been added to reflect significant changes in the technologies that make up IT Infrastructure, including:.
The first edition was published in , the IT infrastructure used on these days is far from the current one. IT infrastructure has increased its power and it has appeared new systems that are vastly used by IT departments. In this second version the scope of the qualification is extended to new systems and services like virtualization technologies, Cloud Services SaaX and third parties contractors like datacenters. Demonstrable training. Processes and procedures Effectiveness. Once the system is qualified, next change controls may lose qualification status.