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April 2010

Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

Kerry Potter

What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to successfully pass any inspection.

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Improving Data and Content Migration Testing: A Top Ten for Getting Data and Content Migration Testing on the Right Track

David Katzoff

Traditionally, migrations have been tested using some form of post-migration testing, often limited to sampling. While this certainly has a role for some migrations, it starts relatively late in the overall process, is labor intensive, and misses many data-level errors. These limitations particularly come into play in highly regulated companies where the required margins of error are not feasible.

This article introduces a broad set of data migration testing techniques beginning with pre-migration testing. These techniques are all well established and offer a number of benefits. After a review of these techniques, a set of "top ten" recommendations are provided for the design of an appropriate migration testing strategy.

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The Challenges of Change Control

Maintaining a validated state of equipment, utilities and processes is a basic component of a quality system as defined in current regulations, and to that end, changes made to equipment, utilities and processes need to be documented through a formal change control program, which will naturally be different from one company to another. However, the basic expectations—luckily—of a successful change control program can be summarized.

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Did you know that supplier evaluations differ from audits in scope, requirements? "What's the difference between a supplier evaluation and an audit, from FDA's point of view?" you might ask. Find out from EduQuest, a global team of compliance experts, what the main differences are and learn how to prepare for both.
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