Chicken Little Was Right: FDA Will Enforce Part 11 “Soon”
No one likes to be told he’s crying wolf or acting like Chicken Little squawking about the sky falling.
Big NERC CIP Changes Looming
In less than a year the sweeping changes to the NERC CIP requirements will become effective. The changes will require that all registered facilities be considered, to some degree, a critical asset.
FDA to Medical Device Companies: Forget Global Warming, it’s About to Get Really Cold
Is it time for medical device companies to panic? Yes and no.
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Chicken Little Was Right: FDA Will Enforce Part 11 “Soon”
Michael Causey, Editor & Publisher, eDataIntegrityReport.com I’ve got to admit, despite months (or years?) of hearing from those inside and close to the FDA that the agency intended someday to begin actual enforcement of 21 CFR Part 11, I was beginning to have my doubts. No one likes to be told he’s crying wolf or acting like Chicken Little squawking about the sky falling. Finally, however,... [Read more]
Big NERC CIP Changes Looming
James Holler, Founder, Abidance Consulting In less than a year the sweeping changes to the NERC CIP requirements will become effective. The changes will require that all registered facilities be considered, to some degree, a critical asset. There are going to be three levels of criticality when it comes to CIP – High, Medium & Low. According to NERC, the process and criteria currently being used... [Read more]
FDA to Medical Device Companies: Forget Global Warming, it’s About to Get Really Cold
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Geologists, archeologists and the like usually examine things in terms of hundreds of thousands of years: Think the Paleolithic Era which they measure from the introduction of stone tools by pre-humans or hominids such as Homo Habilis about 2.6 million years ago, to the introduction of agriculture around 12,000 years ago. That’s nearly... [Read more]
NERC Debuts Enhanced Alert Mechanism, Reviews Challenging 2009
NERC just rolled out its NERC Alert System (NAS), which gives NERC/ES-ISAC the ability to alert and notify NAS-registered entities of the bulk power system (BPS) of vulnerabilities, threats, and/or abnormal events/conditions that could impact the BPS. It is also designed to enable rapid Alert creation and dissemination of alerts and provides for quick acknowledgment and response from Alert recipients... [Read more]
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]
Risk Management Matures Beyond the Spreadsheet
Risk management is one of those terms that is often used a bit too loosely, warns AssurX’s Sal Lucido. “People say ‘risk management’ but it can mean very different things to people working at different parts of a company.” For example, the finance and accounting department focuses on documenting and managing risks associated with business financial transactions and reporting as governed by... [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]
