Guest Author: Hillari Allen
What Hillari is reading tonight
Most of us spend a few hours a day browsing the web for our news, gossip, social media and we also try to stay on top of information in our respective professions. Hillari our Director of QA came across an interesting abstract online that she started reading and wanted to share titled ‘Building Quality in Clinical Trials With Use of a Quality Systems Approach‘.
In the words of Hillari
“In the world of Clinical Research, quality data is key to reporting accuracy, as well as for the efficacy of the products they represent. The same is for the SaaS business model.
In this industry, not only do the Clinical Research Organizations have to validate their data in a tightly regulated manner, but SaaS companies have to abide by many of the same standards and regulations, in order to be accepted in this industry, and in order to compete.”
We found this article not only a testament to goBalto processes, but inspiring since we have instituted building a quality system, since inception.
Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
Reprints or correspondence: Dr Cynthia Kleppinger, Div of Scientific Investigations, OC/CDER/FDA, Federal Research Center, Bldg 51, Rm 5352, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 (Cynthia.Kleppinger@fda.hhs.gov).