Jul 01 2014

New FDA Drug Quality Regulations Require Detail Reporting
Recent news has custom-drug makers under public and government scrutiny.  The US Food and Drug Administration has citied drug makers for not meeting new regulations passed by President Barack Obama when he enacted the federal Drug Quality and Security Act in November of 2013.  This new act is designed to rein in larger drug facilities […]
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Sep 22 2014

Norton Symantec Antivirus Update
On Sept 16th, 2014 , there was a Norton Symantec antivirus update that happened to some customers. After the update NMIS HL7 users experienced their NMIS HL7 interface no longer working.  Our technical support team diagnosed the issue and tracked it down to Tuesday mornings Symantec virus definitions update.  It was flagging the NMIS HL7 interface services […]
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Oct 07 2014

FDA Compliance
        Dear Regulatory Affairs, I’ve spent my entire career working in and around FDA regulated medical activities. I know the frustration, anxiety and added expense one experiences preparing for and enduring an FDA inspection. Eight years ago I was overseeing cyclotron operations at a number of different facilities and anticipating that the […]
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Nov 18 2014

News from the FDA regarding Cybersecurity
At ec2 Software Solutions, we hope that our clients are up to date on the latest FDA news. Recently, the FDA finalized its recommendations to manufacturers regarding Internet security of medical devices. The FDA recommends all medical device manufacturers consider their cybersecurity risks and create a plan to actively manage these risks. It is imperative […]
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Mar 23 2015

CryptoWall, the Virus du Jour
  Even tech-savvy computer users (especially those in the software industry!) will eventually suffer the effects of a virus. The latest threat is known as CryptoWall, and like many of its predecessors, it is a Trojan horse type virus. As with most viruses, CyptoWall delivers its nasty payload via an email attachment or other non-threatening […]
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Mar 31 2015

BioTrax QMS Enables Prestigious Cyclotron Facility to Improve FDA Compliance
The Situation The Cyclotron Radiochemistry Lab at Huntsman Cancer Institute is located on the University of Utah Campus in Salt Lake City. A concern about the efficiency of a paper based quality system was the driving force behind their search for an electronic solution. Representatives from Huntsman Cancer Institute turned to industry trade shows and […]
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Apr 08 2015

SNMMI Annual Meeting Heads to Baltimore
Each year ec² Software Solutions has the privilege of attending the industry’s premier education and research meeting in molecular imaging and nuclear medicine. SNMMI always  provides the nuclear medicine and molecular imaging community with the most up-to-date information in the field. We look forward to joining more than 4,000 attendees  this year in Baltimore, MD, for the 2015 Annual Meeting. This year’s educational program provides […]
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May 26 2015

FDA INSPECTION RESULTS – PET DRUG FACILITIES 2013-2014
When keeping your facility compliant and ready for an FDA audit, its important to have as much information as possible. Below is a list of 2013-2014’s FDA PET Facility audit results. TOP 6 Major Issues Lack of adequate out of specification (OOS) investigations Inadequate media fill validations, aseptic techniques and environmental monitoring Analytical assay methods […]
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