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Easier FDA Audits With Google Search Appliance



The U.S. government recently disclosed the amount of time it takes to comply with the FDA’s requirements for the reporting and recordkeeping of human drugs and biologics, related to Investigational New Drug (IND) applications. It probably won’t come as a surprise that it takes an exhausting 22,801,297 total hours. Yes, you read that correctly. 

Of that total, 413,196 hours are dedicated to just recordkeeping. Now, multiply that by the number of drugs you’ve launched or are trying to launch, and you have yourself an Herculean task of managing those records. Now, imagine having an FDA audit and being tasked to find a specific document? Oy vey!

With the Google Search Appliance (GSA), the record management process can be simplified. Think of GSA as Google (because it is), but for your documents and your systems. The solution can connect to almost any system, such as a document management system, CRM, portal, or even a clinical or drug safety system. It can search text in almost any file format, even documents that have been scanned using optical character recognition (OCR) software. How many old paper records does your organization have sitting in storage and how well are they organized?

While GSA can be extremely helpful in an FDA audit, there are myriad other use cases for such a tool. The ability to provide users with the content they’re looking for is where GSA excels. And, naturally, the more content you have, the harder it is to find what you’re looking for, and the more useful GSA becomes.

If you’re interested in having (or improving) the ability to search your systems for relevant content, let us know. We even offer a free structured engagement that helps identify your business challenges and where GSA can help.

You can also join Google’s Head of Search, Rob Cocks, and Perficient’s Google Practice Director, Chad Johnson, for an upcoming complimentary webinar in which they will discuss why and how life sciences companies can leverage the GSA to save time, money, and eliminate frustration.

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Rod Roderick

Rod Roderick is a Business Development Executive in Perficient’s life sciences practice.

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