Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 24 March 2014 | By Alexander Gaffney, RAC
Pharmaceutical regulators at the US Food and Drug Administration (FDA) handle massive amounts of data on a regular basis, including data on inspections, approvals, recalls, adverse events and more. But as a new FDA notice indicates, agency officials are now just as interested in what they can do with their data as they are in collecting it.
The 18 March 2014 Federal Business Opportunities (FBO) notice explains that FDA's Center for Drug Evaluation and Research (CDER) uses a variety of "unique" information technology systems, reporting tools and processes that pool business and regulatory data from a variety of sources.
However, data are presently not "stored, organized, and presented in a way that facilitates ease of use, consistency, and performance," the regulator observed. What FDA needs, it says, is a "core set of reporting and analytical capabilities" to help it "enhance the overall capability to approve safe and effective medical products."
Luckily, FDA is already well on its way in this regard, having already purchased an off-the-shelf software tool known as the OBIEE Foundation Suite Business Intelligence tool, which it says will allow it to analyze and report on its own data.
But FDA's FBO notice indicates that it now wants something else: The ability to view its information in map form.
"The objective is to acquire and integrate the geospatial digital map database into CDER's analytics platform," FDA wrote. "The geospatial data will reside in the Oracle database and provide the OBIEE tool the capability to pinpoint an address related to FDA business functions on a map. This feature will benefit end users by providing them a capability to view information on a map and then be able to perform analytics using standard OBIEE tool capability."
Calling its current data analytic capabilities "deficient with regard to visualizations," FDA said the focus of the mapping project would be pharmaceutical quality. Specifically, by being able to geo-map all of the facilities that manufacture a particular drug product in case of quality or manufacturing issues, FDA will be able to quickly pinpoint trouble spots and deploy resources to address problems.
Whatever geospatial system FDA selects, it will need to be compatible with its current OBIEE tool, it said. Responses are due to the agency by 28 March 2014.
FDA Geospatial Data Software Notice
Tags: Pharmaceutical Quality, Geospatial, Mapping, Latest News, data