SOFIE Regulatory Intelligence System

Biz Report

So, we live in an increasingly regulated environment.  Regulated industries like healthcare are finding themselves buried in new regulations and massive amounts of information.   A company called Graematter has developed a patented software solution that integrates and cross references this data into a regulatory intelligence system with advanced search capabilities.

Healthcare regulation has taken the spotlight – namely, medical devices and pharmaceuticals – which are regulated by the FDA. Much like a lawyer reviews case law to prepare a position they will defend in court; regulatory professionals must research precedent information to develop a regulatory strategy that they can present before the FDA.   The problem is that this vast information is spread over more than 130 databases.  It is very time-consuming and if critical documents are missed, the regulatory process will be much longer and more-costly or they can even fail to get approval.  The Graematter System allows regulatory professionals to find, organizes, and analyze critical data they would have otherwise missed.  It also reduces the typical research process from a three-week process to less than two hours. Created from government data, the Graematter System is what is now referred to as an Open Data system and has the potential to be used in any regulated environment.

“The original concept for the regulatory intelligence system was conceived by Graematter’s founder, Melissa Walker, in 1999. An early-stage, pre-prototype version of the system was first created in 2000. It began as an effort to simply improve the ability to locate key information. As the volume of regulatory information began to expand dramatically and as the regulatory environment became increasingly complex, it continued to evolve.  Over time, Ms. Walker developed an intelligence system that provided simple, lower cost ways to better retrieve and analyze large amounts of data that reside in numerous locations. The evolving system has been in continuous use in actual applications during that time as its capabilities were expanded and improved.”

To learn more, head to today. Or join them at one of their upcoming events such as RAPS Regulatory Convergence in Baltimore, Maryland from October 26-27th.

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