Loftware Blog / Regulatory

by Craig Hodgson, on May 11, 2018

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 …

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Topics:Medical DevicesRegulatory

by Craig Hodgson, on May 4, 2018

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 …

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Topics:Medical DevicesRegulatoryLabeling

by Craig Hodgson, on April 25, 2018

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 …

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Topics:Regulatory

by Laura Johnson, on April 20, 2018

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 …

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Topics:Medical DevicesLife SciencesRegulatory

by Craig Hodgson, on April 9, 2018

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 …

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Topics:RegulatoryLabeling

by Jay Crowley, on March 29, 2018

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 …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on March 5, 2018

When health care data isn't stored on paper, efficiency and accuracy can improve. Using GS1 labeling standards in health care is one of the major ways to speed up a …

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Topics:HealthcareRegulatoryLabeling

by Max Manikian, on February 23, 2018

Bracodes and warehouses go together, and the connection is deepening. The era of warehouses managed manually is quickly passing into history. Today's fulfillment and distribution centers are too large - …

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Topics:Supply ChainRegulatoryLabelingLogistics

by Guenther Martin, on February 19, 2018

Barcodes remain an essential tool in pharmaceuticals. The need for accurate pharmaceutical tracking, enabled by barcode labels, is clear due to the potential consequences if data is insufficiently traceable. Quality …

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Topics:PharmaceuticalsHealthcareRegulatoryLabeling

by Laura Johnson, on February 16, 2018

Staying compliant with regulations in the pharmaceutical industry is a constant battle. Many organizations struggle to adapt and stay ahead of the constant changes and updates, including the most recent …

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Topics:PharmaceuticalsRegulatorySAP Labeling

by Craig Hodgson, on February 7, 2018

We’re fast approaching the three-year anniversary of GHS deadlines. That’s of course when U.S. companies had to comply with OSHA’s Hazard Communication Standard (HCS) for the classification and labeling of chemicals, which …

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Topics:Supply ChainRegulatoryLabeling

by Maureen Perroni, on January 17, 2018

The complex food supply chain benefits from easy data exchange. Food safety isn't quite like the consumer protection built into any other industry. Food and beverage products, often bearing short …

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Topics:Supply ChainRegulatoryLabelingFood & Beverage

by Harald Desjarlais, on December 18, 2017

When auto parts are easily traceable, recalls stand a better chance of being quick and efficient. While no manufacturer of auto parts or finished vehicles wants its products to be …

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Topics:AutomotiveRegulatoryManufacturingLabeling

by Scott Vigneault, on December 14, 2017

What can make the retail supply chain quick and visible? Companies shipping goods around the world with increasing volume and velocity can only operate at their peak efficiency if they never …

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Topics:Consumer ProductsRegulatoryRetailLabelingLogistics

by Max Manikian, on December 11, 2017

The IoT can illuminate the manufacturing world in ways that were previously impossible. The tiny, mechanical actions transporting products from one stage of the manufacturing process to the next benefit …

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Topics:RegulatoryManufacturing