Insights Blog

Smart Decisions Behind a Successful FDA Inspection with eRegulatory

Posted on Jun 26, 2018 12:30:20 PM
New Case Study Offers Insight into an FDA Inspection from a Research Site using eRegulatory 

If you find yourself standing on a railroad track, you can expect that at some point you’ll hear the distant whistle and rumble of an oncoming train. At that moment the smart decision is to step off the track in preparation of the train’s arrival.

For clinical research sites, FDA inspections are a bit like an oncoming train. They don’t whistle or rumble,  but you know they are coming. You just don’t know exactly when. The difference between getting rolled over by the inspection and surviving unscathed comes down to preparation. What are you doing to step off the tracks?

How you answer that question is particularly important If you’ve recently made the transition from paper documentation to an eRegulatory system. Whatever you did to prepare for an inspection under your old paper-based system may no longer be relevant.

Smart Decisions Behind a Successful FDA Inspection, a new case study from Complion, shares the details of the steps Neal Surasky and the staff at Chesapeake Research Group (CRG) took to prepare for an FDA inspection of their eRegulatory system.

While this certainly wasn’t the first FDA inspection Neal had experienced at CRG, this was the first after the implementation of Complion’s eRegulatory solution. “All the other studies we had done involved paper binders,” Neal says in the article.

The article presents Neal’s insight into the inspection process, the advance preparation, and the adjustments made to help to ensure a positive outcome.  You’ll learn about the special considerations driven by the differences between a paper-based system and eRegulatory, and how the team at CRG took advantage of features in the eRegulatory system to keep the inspectors happy.

Download your copy of Smart Decisions Behind a Successful FDA Inspection from Complion.

Your FDA inspection is coming. Are you ready?Case Study: A Research Site's FDA Inspection with eRegulatory

Topics: eRegulatory, Paperless Clinical Trials, Compliance, Regulatory Compliance, FDA Inspections, Paperless Research Sites, Electronic Signatures

Abbie Hosta

Written by Abbie Hosta

Abbie manages the educational and marketing efforts at Complion, a company dedicated to transforming the way clinical trial documentation is maintained. She is passionate about technology, education, and finding new ways to solve old problems. Her goal is to deliver knowledge and value in every interaction. Abbie has a B.A. from Baldwin-Wallace University where she studied Marketing and Human Resources.

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