Regulatory Focus™ > News Articles > FDA Transitioning to Tablet-Based Inspection System for Food, Pharmaceutical Facilities

FDA Transitioning to Tablet-Based Inspection System for Food, Pharmaceutical Facilities

Posted 18 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is laying the groundwork to eventually transition away from the use of paper-based inspection journals in favor of digital-based tablet inspection aids, say several FDA officials.

The agency, including FDA Commissioner Margaret Hamburg, has recently begun to tout its use of a new, Windows-based rugged tablet computer for use during egg  farm inspections.

An FDA spokeswoman, Patricia El-Hinnawy, told Regulatory Focus that the agency is using the technology to replace its manual paper process, most commonly associated with the agency's iconic green inspection notebooks.

"The Egg Farm Inspection Prototype System (EFIPS) tools use intelligent questionnaires to guide the investigators through inspections," explained El-Hinnawy. "This system of intelligent data gathering saves time by targeting questions and alleviates note taking required by the current pen and paper system."

The benefits to this system are numerous, she said. "This saves a considerable amount of time during the inspection and helps ensure that regulations are being applied to the deviations uncovered by our investigators." Other benefits involve the device's physical properties, such as being able to be sanitized.

An added bonus: Because the system is so much more efficient than past inspections, it is actually projected to save FDA money-some $70 million, its economists predict.

Thinking Differently with the EggPad

The device, a Panasonic Toughbook, has been dubbed the "Egg Pad" by internal staff-a play on Apple's iPad-and runs on software developed by consultancy Booz Allen Hamilton.

The device is used to cross-check a facility's deviations with the latest versions of the Code of Federal Regulations, generate draft reports at the facility, and make sure deficiencies are responded to appropriately by staff.

"The system will streamline and improve our inspection reporting processes," said Commander Scott Lewis, deputy to FDA's senior IT advisor, in a video the agency posted on YouTube. "The data that we capture can be used for better risk modeling."

Coming Soon to Pharmaceutical Inspections

If the inspection system eventually spreads to other areas within FDA-and it likely will at some time after the first quarter of 2013, say agency officials-it will likely have been at the urging of the Office of Regulatory Affairs (ORA), which conducts inspections for the agency. In an April 2012 address to the Food and Drug Law Institute, Dara Corrigan, then-Director of ORA, told conference attendees that the agency is moving toward more digital approaches to information gathering.

"Most of the time, we're still using green notebooks, and we need to get past that,'' Corrigan said. The real-time entry of data can also allow for greater and immediate feedback for agents in the field, as well as the ability to conduct more rapid recalls if necessary.

Corrigan remarked to AOL Governmentin April that the agency is currently in the process of evaluating, "the next place where we are going to [implement the technology]."

"It's capable of being moved rather than standing still."

Corrigan later said in an address posted on YouTube that she is, "Confident that if we go in that direction-and we will-that we will be able to conduct better, more efficient inspections both on the food side and the drug side."

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