Is the FDA getting ready to crack down on medical device clinical trials?

Michael Causey, Editor & Publisher, eDataIntegrityReport.com Well, we told you 2010 was going to be a big year for the FDA. While most of us were enjoying holiday treats or making new year’s resolutions, a leading FDA official said the agency was developing new guidelines designed to establish stricter standards for the data received from tests with human subjects used by medical device makers... [Read more]

FDA Takes Food Safety Seriously With Electronic Reporting System

Michael Causey, Editor & Publisher, eDataIntegrityReport.com Is it just me, or does it seem like someone must have reminded the FDA that the first part of its name starts with the word “Food”? In the past several weeks we’ve seen a very public and very aggressive FDA take some big steps to assure consumers that their food is safe after a bad year or two out there in America’s food chain.... [Read more]

FDA Moves to Mandate eMDR by February 2011; Will Device Firms be Ready?

Michael Causey, Editor & Publisher, eDataIntegrityReport.com Well, they finally did it. After more delays and internal intrigue than your typical Hollywood Blockbuster, the FDA today unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports. It’s going to save time (paper submissions take up to two weeks to process at FDA HQ) and money... [Read more]

NERC Standards Management: Beyond the Spreadsheet

As we all know on August 8, 2005, President Bush signed into law the Energy Policy Act of 2005, which authorized the creation of an electric reliability organization (ERO) with the statutory authority to enforce compliance with reliability standards among all market participants.  The electric industry has had to adjust to the change from a voluntary system of compliance to a mandatory system of reliability... [Read more]

Who Says You Can’t Integrate Systems in Software as a Service (SaaS) Environment?

The idea of software as a service is not new and in fact AssurX has offered its CATSWeb enterprise quality and compliance system in a hosted environment for over 10 years.  However, there has always been a certain resistance in business for utilizing this software model.  The reasons have varied from security issues to wanting to have control over the platforms to a perception that the data just... [Read more]