GAMP GOOD PRACTICE GUIDE IT INFRASTRUCTURE CONTROL AND COMPLIANCE PDF

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.

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Citations are based on reference standards. It also offers a scalable framework which can be applied to different platform types to determine the scope of qualification efforts.

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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.

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New Guidance Document - ISPE GAMP® Good Practice Guide: IT Infrastructure Control & Compliance

Zujora Finding libraries that hold this item Updated information has been added to reflect the changes in the technologies that make up IT Infrastructure, including: Subjects Pharmaceutical technology — Automation — Quality control. Would you also like to submit a review for this item? View the discussion thread. Privacy Policy Terms and Conditions. August 31, Please select Ok if you would like to adn with this request anyway. Your request to send this item has been completed. Create lists, bibliographies compliancee reviews: You may send this item to up to five recipients.

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