Tag: manufacturing software

Dec 23 2014

Cybersecurity and Managing your Information Online
There are more reasons than ever to think about your online safety: in addition to cyber-thievery, hacking and identity theft, a growing number of information is gathered via social media. And the concern is not only for the general public and consumers, it also extends to corporate HQs and into the healthcare industry. Recently, the FDA […]
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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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Nov 12 2014

Maintaining Good Manufacturing Practices
It is important that manufacturers of isotopes and radiopharmaceuticals maintain consistent high quality when supplying pharmacies and PET centers. It is critical that the products provided by the nuclear medicine industry allow for safe and effective imaging and treatment of disease. Toward this end, good manufacturing practices have long been promoted by the FDA to […]
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Nov 04 2014

Evolve Beyond Paper with BioTrax QMS
The FDA published it’s top 6 major issues for 2013/2014 as PET Inspections major issues in 2013/2014. Note how many of them are about records: Lack of adequate “Out of Specification” investigations Inadequate media fill validations, aseptic techniques and Environmental Monitoring Analytical assay methods not validated or verified for intended use Deficiencies in production and […]
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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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Sep 26 2014

LEU Isotopes for Nuclear Imaging
HEU or Highly Enriched Uranium is uranium that can be developed into nuclear weapons. The Global Threat Reduction Initiative (GTRI) was signed by President Obama in an effort to permanently reduce the threat of weapons of mass destruction. The Highly Enriched Uranium (HEU) Reactor Conversion sub-program was developed to work with manufacturers to convert the […]
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Aug 27 2014

Radiopharmaceutical Manufacturers Need Quality Management Software
Radiopharmaceutical manufacturers offer many Nuclear Medicine products that provide safe and effective techniques to image the body and treat disease. Manufacturers are developing new and innovative nuclear medicine treatments that target and pinpoint molecular levels within the body.  These manufacturers are revolutionizing the understanding of and approach to a range of diseases and conditions. Hospitals […]
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Apr 03 2014

BioTrax QMS Software For Your Facility
The BioTrax QMS software facilitates regulatory compliance, increases efficiencies, improves quality and reduces operational costs.  To be able to accomplish this BioTrax QMS integrates the programs document repository, raw materials, production, equipment, training and facilities modules into a single comprehensive package.  The integration of these modules allows the production staff, quality staff and management to […]
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