We recently shared how Unique Device Identification (UDI) systems are an integral part of streamlining regulatory processes. There are also numerous articles touting the benefits of cloud-based labeling solutions further supporting the importance of medical device labeling. What we don’t often hear about are the personal stories of how these regulatory processes and labeling solutions […]
We have shared many articles about the highly regulated pharmaceutical industry. Still, we don’t often think about all the other products the FDA may periodically come across through inspections that we don’t categorize as pharmaceuticals. A well-known natural ingredient toothpaste brand needed to make swift changes when the FDA accused the toothpaste maker of bacteria-tainted […]
We have spoken frequently about the importance of Unique Device Identification (UDI) systems and their ability to improve traceability of medical devices throughout the supply chain to ensure patient safety. Our partners at Loftware share more about navigating global UDI systems and how they are “an integral part of streamlining regulatory processes.” As mentioned above, […]
When discussing the optimization of a company’s labeling solution, we highlight the innovative strategies they implement to demonstrate how a strong supply chain can effectively adapt to rapid changes and updates. Labeling plays a crucial role in this process, ensuring the smooth and efficient operation of the entire supply chain. When news like “Texas Instruments quadruples […]
Our Loftware partners conducted a recorded webinar discussion with pharma experts about how regulatory labeling challenges impact the global pharmaceutical industry. During this webinar, the conversation covered: Standardizing global labeling operations Integrating labeling with existing business applications Increasing supply chain efficiency and agility The opportunity to hear from industry experts with firsthand experience working within […]
When thinking about labeling, we often only consider the process—manufacturing, inventory control, and supply chain management. However, it’s important not to overlook the products themselves. Regulatory and compliance requirements for labels constantly change depending on the product, whether medical devices, pharmaceuticals, or various chemicals. Navigating EU CLP compliance cloud-based solutions from Loftware will help many […]
The Universal Device Identification (UDI) system was developed by the U.S, Food and Drug Administration (FDA) as global UDI compliance to protect patients and clinicians by improving traceability of medical devices through a common and shared system. It has and continues to fulfill its role in safety and traceability tenfold and medical device software has […]
Accuracy in healthcare is essential, if not expected because one incorrect piece of information can result in irreparable damage to a patient. Medical devices “can be complex, but clear and accurate labeling ensures that the right information, directions, warnings, and risks are available to the healthcare professionals who use them.” Loftware shares why medical device […]
“The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The final rule is a key component of the FDA’s New Era of […]