Computer and Software Validation

GXP
At IVT's 15th Annual Computer and Software Validation Conference, Joseph Zec and Lana Tong discussed the source of much of the discord between the quality assurance (QA) group and the information technology (IT) group. As they discuss in this presentation, much of the hostility between the two groups comes from different mindsets and perceived mutually exclusive goals. However, as Zec and Tong explained, there are some clarifications,...

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Schedule Myths vs Facts Understanding misinterpretations related to Part 11 What is really applicable to the industry?...
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The benefits of a unified and consistent configuration management process are expounded in Joe Zec's session from IVT's 12th...
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A virtual environment is a combination of hardware and software that works in tandem to simulate a real world computer...Download
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Network infrastructure qualification is a rapidly evolving, multi-faceted practice. As desktops, servers, network services,...Download
During the finale of his presentation at IVT's Validation Week East Coast Update, Joseph Zec analyzed the intricacies of documenting validation protocol results. The regulatory expectation of objective evidence, as per US Food and Drug Administration's General Principles  of Software Validation, is explained. Zec led the audience through handling test deviations, the issue management...
The staff of IVT were onsite at the 2015 EU Validation Week held in the center city of Amsterdam's Crowne Plaza Hotel. Check out some photos from the conference's opening speeches.
The configuration management activities for computerized systems were thoroughly detailed by Joseph Zec at IVT's 12th Annual Change Control conference. Zec illustrated each aspect of compliant configuration management, including establishing baselines, mechanics of execution, and the change control sub-process.
GXP
Here the name of the game is remediation for compliance. The Part 11 requirement has not changed, however, its interpretation and enforcement has in light of the new Food and Drug Administration (FDA) guidance document. For us, what was begun, is now being completed. A task force was assembled in order to create a matrix to apply the legislation created and passed in 1997 to those systems being...
GXP
In today’s environment of technology and automation, it is important to understand disaster recovery (DR), business continuity (BC), and contingency plans (CP) and how they all work together to ensure continuity and integrity of systems and availability of data and records System owners and technology professionals should understand how these plans should be developed and when/how to exercise...

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