The Journal of GXP Compliance
Vol. 20, Issue 1, Jan 2016

Ivan Soto
The validation of laboratory instruments is one area of continued debate in the industry. One of the biggest debates is whether a URS document is needed or whether using only the vendor qualification package is enough. Some other debates are related to whether Part 11 functions need to be enabled in the system. Many of debates are driven by...
Ivan Soto
One of the biggest challenges some companies have is the validation of legacy computer systems. As the validation requirements and expectations change over the year’s companies struggle with the strategy for validating legacy computer systems Validation planning for legacy computer systems can be challenging for some companies due to lack of...
Karen Ginsbury
At IVT's 21st annual Validation week in Philadelphia, Karen Ginsbury gave this presentation to a packed house. Later that day she was voted IVT Network presenter of the year.
Jerry Lanese and Timothy J. Fields, editors
“GXP Talk ” provides a forum for compliance practitioners to address issues identified by the readers of the Journal of GXP Compliance.
Richard C. Wedlich
Kevin J. Webb
The quality agreement (QAG) between a pharmaceutical company and its partnering contract research organization (CRO) is essential. This discussion outlines the elements of a useful quality agreement. It provides details of a simple procedure that the CRO can use to ensure that the terms of the quality agreement are implemented.
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