The Food and Drug Administration (FDA) requires that all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI). TEKLYNX labeling software helps businesses comply with 21 CFR Part 11, and is capable of printing HIBC and GS1 barcodes required to generate labels for UDI compliance, with support for thermal and thermal transfer printers.
The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was enacted to improve safety and protect the health of workers within the chemical industry. The Final Rule states that as of June 1, 2016, all chemical manufacturers, importers, distributors and employers must comply with all modified provisions. TEKLYNX offers two GHS label software solutions for GHS labeling compliance.
FDA 21 CFR Part 11 was established to protect the public health and ensure accuracy of electronic medical records. It also enables organizations to reduce costs by using electronic records in lieu of paper. TEKLYNX CENTRAL CFR was designed specifically to address FDA 21 CFR Part 11 and UDI requirements.
The EU MDR is designed to ensure public health and safety across Europe and to increase quality and transparency of medical devices through label design, approval, and tracking standardization
Easily create serial numbers to be labeled on prescription drugs to comply with the FDA's Drug Supply Chain Security Act (DSCSA)
Built-in formulas to generate Voice Pick codes that can easily be incorporated into PTI-compliant label designs
Be prepared to comply with the Nutrition Facts label by leveraging label templates with variable data
GS1 barcodes are a worldwide standard used for traceability of all logistic units
Secure label approval, traceability, and label storage software helps you comply with food & beverage industry standards and regulations such as the Food Safety Modernization Act (FSMA)
Automate stylistic differences for allergens when they appear in an ingredients list to comply with EU Regulation 1169/2011 on the Provision of Food Information to Consumers (FIC)
Stay on top of emerging Food & Beverage labeling regulations, such as alcoholic beverage labeling, and leverage TEKLYNX to stay compliant
Create AIAG compliant labels accurately and efficiently
Create UID compliant labels that include 2D Data Matrix, linear barcodes, and a human readable
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