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Improving safety procedures with GHS Labeling

We can all agree that safety is a top priority within a company; however, depending on the tasks at hand safety could be the highest priority.  GHS (Global Harmonized System for Hazard Communication) was created as a solution for hazardous materials being handled between international boundaries using images to denote the products and the hazard. […]


Pragmatyxs Services: Template Upgrades and Conversions

Continuous change in the requirements for labels leads to difficulties in keeping pace, and your label teams and designers are challenged by competing deadlines for projects. Do you have product templates nearing a compliance deadline? Or just looking for an updated design and logic? Do you need to supplement resources to get all of this […]


PXSmartLabel Print History Reporting Tool

Label Print History provides the means for organizations to reconcile the printing of a label. Print History reconciliation provides an important tool in troubleshooting print issues as well as administering print operation facilities. The ability to easily access configurable information including which template printed, who was the  print operator and what date/time stamp is recorded […]


Globally managing print operations with PXSmartLabel

Managing label and barcode print operations can be a heavy task for any administrator, especially when it comes to controlling operations across the globe. Ensuring that the correct label and the quantities printed are important for supply chain movement and accuracy. A disciplined approach to global label printing that is extended to all of the […]


FDA Ruling to take effect on 10/15/2015

The FDA has recently published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule provides the FDA  with an administrative process for the destruction of certain drugs refused admission to the United States. Many of these drugs come into the United States via international mail. […]


Depuy Synthes reaches 100% compliance on Class II UDI Regulations

Depuy Synthes (www.depuysynthes.com) one of the largest manufacturers of orthopaedic and neurosurgery products has reached 100% compliance for UDI Class II. Pragmatyxs was retained as a strategic partner for DePuy Synthes to achieve this milestone. Pragmatyxs assisted in building the database where all product codes related to UDI are integrated into Depuy Synths ERP system […]


Feedback from UDI’s first roll out

The Pharma and Medical device industry is well informed on the changes being implemented for better device identification and issue tracking known as the UDI ruling. The first wave of requirements for Class III devices is now behind us  and Med Device Online sat down with Jay Crowley, VP and UDI Practice Lead at USDM […]


FDA looking to new sugar labeling regulations

The FDA is continually looking to improve not only the safety of food and drug manufacturing but also to provide a clear understanding of these products to consumers.  The FDA is proposing manufacturers implement labeling changes that identify natural sugars and those added. While including the amount of natural and artificial sugars in a product […]


Second UDI Compliance deadline due in September

In September of 2013 the Unique Device Identification (UDI)  Ruling was put into action responding to the demand for more clarity, understanding and an easier way to update medical devices.  Manufacturer’s have been implementing this ruling into their processes and come September 24, 2015 the second deadline will be put into action.  Non-class III implantable, […]


Ruling to come soon on updating generic drug labels

Drug Manufacturers  need to provide customers with  vital information on their product labels such as product ingredients and the possible side effects of the product. This information has become a top priority with any drug manufacturer.  Unfortunately we have seen many incidents where products did not contain the proper warnings and the outcomes can be […]