Compliance Labeling Solutions for UDI and GHS Initiatives
Compliance labeling is a growing demand in many industries from GHS requirements in chemical manufacturing to FDA UDI requirements in medical device production. There are many other companies facing compliance rules from various vendors, manufacturers and partners.
With numerous label printer and label design software options, BCI is strategically equipped to help you design and implement label printing solutions that meet all of your company’s GHS and FDA labeling compliance requirements.
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What is GHS Compliance?
GHS stands for the Globally Harmonized System of Classification and Labeling of Chemicals. GHS was designed and created by the United Nations to become an internationally agreed-upon system.
GHS compliance requires that all manufacturers, importers, downstream users and distributors of chemical substances and mixtures comply with system standards. They are designed to unify the handling of hazardous products and replace existing, country-specific regulations.
With the right label design software and color label printers companies can create a GHS labeling solution that meets all of the compliance requirements.
What is UDI Compliance?
UDI stands for unique identification code and is typically assigned by the manufacturer of medical devices. The FDA UDI rules apply to all medical devices sold in the USA, regardless of where they’re produced.
Due to the FDA’s UDI regulations, use of NHRICs and NDCs for medical devices will be terminated on the date the device must be labeled with a UDI. In the interim, however, you may label your devices with both a UDI and an NHRIC.
The structure of a UDI label includes two segments: a device identifier (DI) and a production identifier (PI). The FDA UDI rule doesn’t require a specific PI be used. It simply requires that whatever PI(s) appear on the device label or package be included in the UDI.
The FDA UDI rule also doesn’t specify which barcode font must be used. The rule only requires that the UDI is presented on the label so that it’s readable for both humans and barcode scanners.
With the right label printers and label design software companies can create a UDI labeling solution that meets all of the FDA UDI rules and requirements.
BCI Solutions for Compliance Labeling Applications
Regardless of your company’s specific compliance labeling requirements, BCI can help design a solution that effectively and efficiently meets all of your labeling compliance needs. BCI has partnered with leaders in label printer manufacturing and label design software development. This gives our customers a direct connection to expert resources in compliance labeling applications.
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