Loftware Blog / Regulatory

Manufacturing speed and flexibility upgrades are welcome in all industries. Sometimes, though, the pharmaceutical sector is left behind when other fields sprint ahead into advanced processes. The latest innovation making …

Labeling regulations always change. Getting regulatory compliance right is one of the most important product manufacturing concerns, regardless of industry. A mistake or misalignment with rules can lead to costly …

What's the key to saving money in labeling-related processes? Some manufacturing process costs are simply unavoidable and can't be reduced any further. Beyond these bedrock expenses associated with producing finished …

Medical device labeling requirements around the world are intensifying. As regulations continue to go into effect around the world, compliant and up-to-date medical device labeling has become an essential element …

Last week’s GS1 Connect event held in blazing hot Phoenix brought together hundreds of key influencers and decision makers from Foodservice, Healthcare, Retail Grocery and Apparel to discuss latest trends …

Manufacturing and transportation of food are more closely monitored than before. The Food and Drug Administration (FDA) has periodically revised the acceptable standards for manufacturers and sellers of foods and …

Getting into compliance with regulations is part of a general supply chain modernization strategy. While relevant regulations and specific practices may differ from one industry to another, there are a …

Heading to GS1 Connect next week in Phoenix? This annual event brings together key influencers and decision makers from Foodservice, Healthcare, Retail Grocery and Apparel to network and participate in …

Blockchain. Machine learning. IoT. There’s a lot of buzz around these technologies and how they’ll transform the supply chain. However, you and your trading partners must be ultra-efficient today. GS1 …

Labels continue to play a critical role in the safe testing, manufacturing, distribution and use of medical devices worldwide. Not only must they comply with a range of regulatory requirements …

Just as you’ve come to grips with the FDA’s Unique Device Identification (UDI) system, along comes the European Union’s version—and a new set of labeling requirements. The EU’s recently published …

In a perfect world, here’s how the supply chain would work: shipments would flow from one party to the next smoothly, without hassles or delays. Regulatory compliance would just happen …

Just as medical device companies have achieved a comfort level with their labeling programs to ensure compliance with the FDA's Unique Device Identification (UDI) system, along comes Europe's version of UDI with …

Managing regulatory compliance has always been a challenge for organizations, particularly those in the Chemical, Medical Device, Pharmaceutical and Food & Beverage industries. The stakes are even higher today as companies …

On January 12th, FDA published an immediately-in-effect (IIE) guidance document titled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices,” (available here). The guidance states that …