Posted by Brad Siefert
In the barcode industry, there is considerable dialogue about (UDI) Unique Device Identification and (MDR) –Medical Device Regulation. We read and hear all about the initiatives and the deadlines, but why are these compliance requirements so important…. These compliance regulations provide for more accurate reporting, content review and the ability to report on device […]
Posted by Brad Siefert
Oracle OpenWorld- How a small business sells world class services to the fortune 500 Pragmatyxs might be a small company, but they have some very big clients. The 15-person firm works with Fortune 500 companies to bridge the communications gap between supply chain or ERP systems and barcode and product labels. “The labels that you […]
Posted by Brad Siefert
The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers is November 27, 2017; the date by which Pharmaceutical manufacturers are required to print a unique product identification […]
Posted by Brad Siefert
The first compliance date for Unique device identification, UDI, class III was September 2014. Class III medical devices are defined as devices that support or sustain human lives, Class III Medical Devices include implanted pacemakers, heart valves and implanted cerebral simulators. At that time the FDA mandated that labels and packages of class III medical […]
Posted by Brad Siefert
Demand for safe packaging to combat illicit drug market rackets spread across the globe is increasing. The present market is plagued by forged pharmaceutical formulas. The soaring market size of counterfeit drugs is creating a parallel economy in the global market. The emerging threat has a rippling effect on all the stakeholders as well as […]
Posted by Brad Siefert
Pragmatyxs Smart Label (PXSL) is our answer to simplifying the label printing process; while it is a very intuitive, easy to use tool to the operator it is a product that allows so much more than meets the eye. Pragmatyxs is constantly reviewing and implementing new features that we feel will improve our customers everyday […]
Posted by Brad Siefert
One of the largest labeling regulations in recent history; UDI (Unique Device Identifier) labeling has been at the forefront of any medical companies agenda to not only implement new information but to also properly display this critical information in a proper fashion. Barcode-test.com provided simple yet resourceful list of common issues that they have seen […]
Posted by Brad Siefert
The G.M.O.(Genetically Modified Organism) labeling rule has been a widely discussed topic in the food labeling industry. While some wanted full transparency on whether products contained G.M.O’s other fought the regulation in its entirety claiming increased production and labeling costs. Congress has agreed to a bipartisan agreement on the matter allowing companies to disclose whether […]
Posted by Brad Siefert
In the labeling industry product validation and label clarity are two of the most important components, whether in the final packaging stage or en-route to other production sites. Clear and precise product labeling provides significant competitive advantages while also meeting regulatory compliance. Pragmatyxs has been evaluating and testing integrating a third party label verification device […]
Posted by Brad Siefert
If you have high volumes of label printing, print speed is of high importance. Many manufacturers are printing thousands of labels on a daily and even an hourly basis. Understanding the difference between ‘Extended’ and ‘Continuous’ mode within BarTender (http://www.seagullscientific.com/) and how to ensure you are falling within one of those modes is critical to […]
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